Trial Outcomes & Findings for Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment (NCT NCT01865448)
NCT ID: NCT01865448
Last Updated: 2019-06-20
Results Overview
Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
6 months
Results posted on
2019-06-20
Participant Flow
Study performed in a single center. The patients attending the Endocrinology and Nutrition Department at the Hospital Clinico Universitario of Valladolid to receive treatment for obesity were consecutively enrolled in this study.
Participant milestones
| Measure |
Control
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
Omega-3 DHA
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Control
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
Omega-3 DHA
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
dropout unrelated to study
|
1
|
1
|
Baseline Characteristics
Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Baseline characteristics by cohort
| Measure |
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Weight (Kg)
|
92.2 Kg
STANDARD_DEVIATION 13.1 • n=5 Participants
|
92.1 Kg
STANDARD_DEVIATION 8.7 • n=7 Participants
|
92.1 Kg
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Body Mass Index (BMI) (kg/m^2)
|
32.9 kg/m^2
STANDARD_DEVIATION 1.9 • n=5 Participants
|
33.4 kg/m^2
STANDARD_DEVIATION 1.4 • n=7 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Waist circumference (cm)
|
109.2 cm
STANDARD_DEVIATION 7.9 • n=5 Participants
|
109.4 cm
STANDARD_DEVIATION 7.8 • n=7 Participants
|
109.3 cm
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
15-HETE
|
51.14 pg/ml
STANDARD_DEVIATION 84.24 • n=5 Participants
|
23.76 pg/ml
STANDARD_DEVIATION 38.35 • n=7 Participants
|
36.9 pg/ml
STANDARD_DEVIATION 64.8 • n=5 Participants
|
|
12 -HETE
|
4985.94 pg/ml
STANDARD_DEVIATION 4301.86 • n=5 Participants
|
5359.26 pg/ml
STANDARD_DEVIATION 3431.47 • n=7 Participants
|
5179.51 pg/ml
STANDARD_DEVIATION 3803.27 • n=5 Participants
|
|
8-HETE
|
43.74 pg/ml
STANDARD_DEVIATION 42.24 • n=5 Participants
|
57.85 pg/ml
STANDARD_DEVIATION 51.38 • n=7 Participants
|
51.06 pg/ml
STANDARD_DEVIATION 46.85 • n=5 Participants
|
|
5-HETE
|
424.39 pg/ml
STANDARD_DEVIATION 209.93 • n=5 Participants
|
369.63 pg/ml
STANDARD_DEVIATION 106.82 • n=7 Participants
|
396.00 pg/ml
STANDARD_DEVIATION 163.78 • n=5 Participants
|
|
TXB2
|
118.20 pg/ml
STANDARD_DEVIATION 133.33 • n=5 Participants
|
131.26 pg/ml
STANDARD_DEVIATION 95.62 • n=7 Participants
|
124.97 pg/ml
STANDARD_DEVIATION 113.2 • n=5 Participants
|
|
PGE2
|
2.82 pg/ml
STANDARD_DEVIATION 6.93 • n=5 Participants
|
0.14 pg/ml
STANDARD_DEVIATION 0.34 • n=7 Participants
|
1.43 pg/ml
STANDARD_DEVIATION 4.91 • n=5 Participants
|
|
LTB4
|
15.08 pg/ml
STANDARD_DEVIATION 29.88 • n=5 Participants
|
0.00 pg/ml
STANDARD_DEVIATION 0.00 • n=7 Participants
|
7.26 pg/ml
STANDARD_DEVIATION 21.71 • n=5 Participants
|
|
17-HDOHE
|
96.56 pg/ml
STANDARD_DEVIATION 87.70 • n=5 Participants
|
133.92 pg/ml
STANDARD_DEVIATION 80.78 • n=7 Participants
|
115.93 pg/ml
STANDARD_DEVIATION 84.70 • n=5 Participants
|
|
14-HDOHE
|
3668.74 pg/ml
STANDARD_DEVIATION 3540.69 • n=5 Participants
|
4071.54 pg/ml
STANDARD_DEVIATION 3150.66 • n=7 Participants
|
3877.60 pg/ml
STANDARD_DEVIATION 3285.03 • n=5 Participants
|
|
7-HDOHE
|
128.55 pg/ml
STANDARD_DEVIATION 52.83 • n=5 Participants
|
120.83 pg/ml
STANDARD_DEVIATION 49.09 • n=7 Participants
|
124.55 pg/ml
STANDARD_DEVIATION 50.08 • n=5 Participants
|
|
4-HDOHE
|
268.36 pg/ml
STANDARD_DEVIATION 148.25 • n=5 Participants
|
288.93 pg/ml
STANDARD_DEVIATION 147.32 • n=7 Participants
|
279.03 pg/ml
STANDARD_DEVIATION 145.27 • n=5 Participants
|
|
RVD2
|
64.89 pg/ml
STANDARD_DEVIATION 74.55 • n=5 Participants
|
50.68 pg/ml
STANDARD_DEVIATION 91.41 • n=7 Participants
|
57.52 pg/ml
STANDARD_DEVIATION 82.44 • n=5 Participants
|
|
PD1
|
6.27 pg/ml
STANDARD_DEVIATION 7.04 • n=5 Participants
|
3.80 pg/ml
STANDARD_DEVIATION 5.27 • n=7 Participants
|
4.99 pg/ml
STANDARD_DEVIATION 6.19 • n=5 Participants
|
|
Sum of proinflammatory mediators
|
5641.30 pg/ml
STANDARD_DEVIATION 4357.98 • n=5 Participants
|
5941.89 pg/ml
STANDARD_DEVIATION 3563.60 • n=7 Participants
|
5797.16 pg/ml
STANDARD_DEVIATION 3890.83 • n=5 Participants
|
|
Sum of proresolving mediators
|
4233.38 pg/ml
STANDARD_DEVIATION 3652.42 • n=5 Participants
|
4669.69 pg/ml
STANDARD_DEVIATION 3334.98 • n=7 Participants
|
4459.61 pg/ml
STANDARD_DEVIATION 3430.36 • n=5 Participants
|
|
Proresolution index
|
0.72 ratio
STANDARD_DEVIATION 0.23 • n=5 Participants
|
0.78 ratio
STANDARD_DEVIATION 0.35 • n=7 Participants
|
0.75 ratio
STANDARD_DEVIATION 0.29 • n=5 Participants
|
|
C-reactive Protein (CRP) (mg/dl)
|
3.3 mg/dl
STANDARD_DEVIATION 1.4 • n=5 Participants
|
3.8 mg/dl
STANDARD_DEVIATION 3.4 • n=7 Participants
|
3.6 mg/dl
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Adiponectin (ng/ml)
|
8.6 ng/ml
STANDARD_DEVIATION 4.2 • n=5 Participants
|
7.9 ng/ml
STANDARD_DEVIATION 3.5 • n=7 Participants
|
8.3 ng/ml
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Resistin (ng/ml)
|
5.3 ng/ml
STANDARD_DEVIATION 3.6 • n=5 Participants
|
4.5 ng/ml
STANDARD_DEVIATION 2.2 • n=7 Participants
|
4.9 ng/ml
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Tnf alpha (ng/ml)
|
4.7 ng/ml
STANDARD_DEVIATION 2.3 • n=5 Participants
|
5.0 ng/ml
STANDARD_DEVIATION 2.5 • n=7 Participants
|
4.8 ng/ml
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Interleukin-6 (ng/ml)
|
4.2 ng/ml
STANDARD_DEVIATION 2.1 • n=5 Participants
|
4.1 ng/ml
STANDARD_DEVIATION 1.7 • n=7 Participants
|
4.2 ng/ml
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Leptin (ng/ml)
|
29.7 ng/ml
STANDARD_DEVIATION 17.7 • n=5 Participants
|
45.2 ng/ml
STANDARD_DEVIATION 22.4 • n=7 Participants
|
37.2 ng/ml
STANDARD_DEVIATION 21.2 • n=5 Participants
|
|
7SMAR1
|
NA pg/ml
STANDARD_DEVIATION NA • n=5 Participants
|
NA pg/ml
STANDARD_DEVIATION NA • n=7 Participants
|
NA pg/ml
STANDARD_DEVIATION NA • n=5 Participants
|
|
7RMAR1
|
NA pg/ml
STANDARD_DEVIATION NA • n=5 Participants
|
NA pg/ml
STANDARD_DEVIATION NA • n=7 Participants
|
NA pg/ml
STANDARD_DEVIATION NA • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsProresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Proresolution Index
|
0.84 ratio
Standard Deviation 0.36
|
0.71 ratio
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: 6 monthsSum of proresolving mediators at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Sum of Proresolving Mediators at 6 Months
|
3409.31 pg/ml
Standard Deviation 2065.58
|
3342.11 pg/ml
Standard Deviation 4132.21
|
PRIMARY outcome
Timeframe: 6 monthsSum of proinflammatory mediators at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Sum of Proinflammatory Mediators at 6 Months
|
3931.00 pg/ml
Standard Deviation 1654.83
|
4276.89 pg/ml
Standard Deviation 35.89
|
SECONDARY outcome
Timeframe: 6 monthsWeight at 6 months (end of the monitoring period)
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Weight at 6 Months
|
72.3 kg
Standard Deviation 7.1
|
71.8 kg
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 6 monthsBody mass index at 6 months (end of the monitoring period)
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Body Mass Index at 6 Months
|
26.2 kg/m^2
Standard Deviation 1.6
|
25.6 kg/m^2
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 6 monthsWaist circumference at 6 Months (end of the monitoring period)
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Waist Circumference at 6 Months
|
89.0 cm
Standard Deviation 5.2
|
87.3 cm
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 2 monthsLevel of c-reactive protein (CRP) at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
C-reactive Protein (CRP) at 2 Months
|
3.2 mg/dl
Standard Deviation 2.9
|
2.3 mg/dl
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 6 monthsLevel of c.reactive protein (CRP) at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
C-reactive Protein (CRP) at 6 Months
|
2.1 mg/dl
Standard Deviation 1.2
|
1.9 mg/dl
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 2 monthsLevel of Adiponectin at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Adiponectin at 2 Months
|
8.6 ng/ml
Standard Deviation 2.6
|
11.3 ng/ml
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 6 monthsLevel of Adiponectin at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Adiponectin at 6 Months
|
7.9 ng/ml
Standard Deviation 3.4
|
9.9 ng/ml
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 2 monthsLevel of Tnf alpha at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Tnf Alpha at 2 Months
|
3.3 ng/ml
Standard Deviation 1.8
|
3.1 ng/ml
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 6 monthsLevel of Tnf alpha at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Tnf Alpha at 6 Months
|
2.0 ng/ml
Standard Deviation 0.3
|
2.0 ng/ml
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 2 monthsLevel of Interleukin-6 at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Interleukin-6 at 2 Months
|
4.3 ng/ml
Standard Deviation 1.5
|
4.0 ng/ml
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 6 monthsLevel of Interleukin-6 at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Interleukin-6 at 6 Months
|
4.9 ng/ml
Standard Deviation 2.0
|
6.3 ng/ml
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 2 monthsLevel of Resistin at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Resistin at 2 Months
|
4.5 ng/ml
Standard Deviation 1.9
|
4.7 ng/ml
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 6 monthsLevel of Resistin at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Resistin at 6 Months
|
3.4 ng/ml
Standard Deviation 1.6
|
3.6 ng/ml
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 2 monthsLevel of Leptin at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Leptin at 2 Months
|
8.5 ng/ml
Standard Deviation 7.1
|
5.8 ng/ml
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 6 monthsLevel of Leptin at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Leptin at 6 Months
|
15.8 ng/ml
Standard Deviation 10.2
|
10.2 ng/ml
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 15-HETE at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
15-HETE at 2 Months
|
49.51 pg/ml
Standard Deviation 49.77
|
101.37 pg/ml
Standard Deviation 136.54
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 15-HETE at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
15-HETE at 6 Months
|
72.95 pg/ml
Standard Deviation 51.50
|
65.65 pg/ml
Standard Deviation 32.65
|
SECONDARY outcome
Timeframe: 2 monthLevel 12-HETE at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
12-HETE at 2 Months
|
5148.86 pg/ml
Standard Deviation 1817.86
|
6526.37 pg/ml
Standard Deviation 3922.55
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 12-HETE at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
12-HETE at 6 Months
|
3226.87 pg/ml
Standard Deviation 1431.22
|
3652.28 pg/ml
Standard Deviation 3488.85
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 8-HETE at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
8-HETE at 2 Months
|
88.25 pg/ml
Standard Deviation 37.00
|
92.05 pg/ml
Standard Deviation 69.45
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 8-HETE at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
8-HETE at 6 Months
|
82.88 pg/ml
Standard Deviation 36.02
|
70.10 pg/ml
Standard Deviation 28.45
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 5-HETE at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
5-HETE at 2 Months
|
399.09 pg/ml
Standard Deviation 126.57
|
512.39 pg/ml
Standard Deviation 362.39
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 5-HETE at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
5-HETE at 6 Months
|
369.10 pg/ml
Standard Deviation 149.68
|
313.75 pg/ml
Standard Deviation 104.23
|
SECONDARY outcome
Timeframe: 2 monthsLevel of TXB2 at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
TXB2 at 2 Months
|
149.31 pg/ml
Standard Deviation 123.06
|
177.96 pg/ml
Standard Deviation 249.02
|
SECONDARY outcome
Timeframe: 6 monthsLevel of TXB2 at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
TXB2 at 6 Months
|
148.01 pg/ml
Standard Deviation 71.79
|
132.57 pg/ml
Standard Deviation 76.49
|
SECONDARY outcome
Timeframe: 2 monthsLevel of PGE2 at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
PGE2 at 2 Months
|
5.58 pg/ml
Standard Deviation 10.77
|
16.58 pg/ml
Standard Deviation 36.39
|
SECONDARY outcome
Timeframe: 6 monthsLevel of PGE2 at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
PGE2 at 6 Months
|
13.31 pg/ml
Standard Deviation 15.46
|
28.73 pg/ml
Standard Deviation 57.82
|
SECONDARY outcome
Timeframe: 2 monthsLevel of LTB4 at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
LTB4 at 2 Months
|
1.49 pg/ml
Standard Deviation 5.58
|
43.41 pg/ml
Standard Deviation 128.46
|
SECONDARY outcome
Timeframe: 6 monthsLevel of LTB4 at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
LTB4 at 6 Months
|
16.31 pg/ml
Standard Deviation 18.99
|
13.34 pg/ml
Standard Deviation 18.30
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 17-HDOHE at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
17-HDOHE at 2 Months
|
213.17 pg/ml
Standard Deviation 109.31
|
172.24 pg/ml
Standard Deviation 123.32
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 17-HDOHE at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
17-HDOHE at 6 Months
|
286.03 pg/ml
Standard Deviation 214.13
|
177.95 pg/ml
Standard Deviation 120.73
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 14-HDOHE at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
14-HDOHE at 2 Months
|
3423.64 pg/ml
Standard Deviation 1452.23
|
3320.96 pg/ml
Standard Deviation 2520.22
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 14-HDOHE at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
14-HDOHE at 6 Months
|
2575.02 pg/ml
Standard Deviation 1833.92
|
2760.07 pg/ml
Standard Deviation 3984.42
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 7-HDOHE at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
7-HDOHE at 2 Months
|
140.10 pg/ml
Standard Deviation 59.71
|
118.46 pg/ml
Standard Deviation 42.42
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 7-HDOHE at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
7-HDOHE at 6 Months
|
190.58 pg/ml
Standard Deviation 56.36
|
149.72 pg/ml
Standard Deviation 47.26
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 4-HDOHE at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
4-HDOHE at 2 Months
|
346.78 pg/ml
Standard Deviation 130.19
|
298.81 pg/ml
Standard Deviation 102.32
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 4-HDOHE at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
4-HDOHE at 6 Months
|
306.24 pg/ml
Standard Deviation 171.67
|
207.26 pg/ml
Standard Deviation 94.35
|
SECONDARY outcome
Timeframe: 2 monthsLevel of RVD2 at 2 motnhs
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
RVD2 at 2 Months
|
23.16 pg/ml
Standard Deviation 39.62
|
29.15 pg/ml
Standard Deviation 37.23
|
SECONDARY outcome
Timeframe: 6 monthsLevel of RVD2 at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
RVD2 at 6 Months
|
31.73 pg/ml
Standard Deviation 44.41
|
31.08 pg/ml
Standard Deviation 33.48
|
SECONDARY outcome
Timeframe: 2 monthsLevel of PD1 at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
PD1 at 2 Months
|
6.06 pg/ml
Standard Deviation 5.69
|
3.70 pg/ml
Standard Deviation 4.99
|
SECONDARY outcome
Timeframe: 6 monthsLevel of PD1 at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
PD1 at 6 Months
|
6.31 pg/ml
Standard Deviation 3.03
|
4.51 pg/ml
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 7SMAR1 at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
7SMAR1 at 2 Months
|
NA pg/ml
Standard Deviation NA
7SMAR1 at 2 months was below limits of detection
|
NA pg/ml
Standard Deviation NA
7SMAR1 at 2 months was below limits of detection
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 7SMAR1 at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
7SMAR1 at 6 Months
|
7.35 pg/ml
Standard Deviation 8.52
|
5.52 pg/ml
Standard Deviation 8.81
|
SECONDARY outcome
Timeframe: 2 monthsLevel of 7RMAR1 at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
7RMAR1 at 2 Months
|
NA pg/ml
Standard Deviation NA
7RMAR1 at 2 months was below limits of detection
|
NA pg/ml
Standard Deviation NA
7RMAR1 at 2 months was below limits of detection
|
SECONDARY outcome
Timeframe: 6 monthsLevel of 7RMAR1 at 6 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
7RMAR1 at 6 Months
|
6.05 pg/ml
Standard Deviation 6.95
|
6.01 pg/ml
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: 2 monthssum of proinflammatory mediators at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Sum of Proinflammatory Mediators at 2 Months
|
5842.09 pg/ml
Standard Deviation 1944.08
|
7470.14 pg/ml
Standard Deviation 4105.76
|
SECONDARY outcome
Timeframe: 2 monthssum of proresolving mediators at 2 months
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Sum of Proresolving Mediators at 2 Months
|
4152.90 pg/ml
Standard Deviation 1545.52
|
3943.32 pg/ml
Standard Deviation 2545.83
|
SECONDARY outcome
Timeframe: 2 monthsProresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Outcome measures
| Measure |
Omega-3 DHA
n=14 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=15 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Proresolution Index
|
0.72 ratio
Standard Deviation 0.19
|
0.55 ratio
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 6 monthsNumber of Participants with Adverse Events as a Measure of Safety and Tolerability of standardized weight-loss programme (PronoKal® Method)and Safety and Tolerability of DHA Supplements
Outcome measures
| Measure |
Omega-3 DHA
n=17 Participants
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
Control
n=17 Participants
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Musculoskeletal and connective tissue disorders
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Blood and lymphatic system disorders (hypotension)
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Gastrointestinal disorders
|
7 participants
|
7 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
General disorders
|
6 participants
|
2 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Nervous system disorders (migraine, cephalea)
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Skin and subcutaneous tissue disorders (hair loss)
|
3 participants
|
1 participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Omega-3 DHA
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=17 participants at risk
Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
|
Omega-3 DHA
n=17 participants at risk
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA: Patients take daily 2 tablets of placebo
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
41.2%
7/17 • Number of events 7 • 6 months
|
41.2%
7/17 • Number of events 9 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculokeletal and connective tissue disorders
|
11.8%
2/17 • Number of events 2 • 6 months
|
5.9%
1/17 • Number of events 1 • 6 months
|
|
General disorders
General Disorders
|
11.8%
2/17 • Number of events 2 • 6 months
|
35.3%
6/17 • Number of events 13 • 6 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/17 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
5.9%
1/17 • Number of events 1 • 6 months
|
17.6%
3/17 • Number of events 3 • 6 months
|
|
Nervous system disorders
Nervous System disorders
|
0.00%
0/17 • 6 months
|
11.8%
2/17 • Number of events 3 • 6 months
|
Additional Information
Dr. Daniel de Luis
Unidad de Apoyo a la Investigacion. Hospital Rio Hortega
Phone: 983420400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place