Trial Outcomes & Findings for Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients (NCT NCT01826422)
NCT ID: NCT01826422
Last Updated: 2018-03-09
Results Overview
We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
At baseline and at months 3 and 6 of supplementation.
Results posted on
2018-03-09
Participant Flow
In this study were enrolled DMD/DMB patients from four Hospitals from Mexico city.
Participant milestones
| Measure |
EPA and DHA
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
EPA and DHA
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients
Baseline characteristics by cohort
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.3 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
8.6 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
8.1 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and at months 3 and 6 of supplementation.We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Body Composition (Body Fat)
Basal
|
172.1 g/Kg of body weight
Interval 84.7 to 530.4
|
232.7 g/Kg of body weight
Interval 122.5 to 542.0
|
|
Body Composition (Body Fat)
Month 3 after supplement
|
180.2 g/Kg of body weight
Interval 95.2 to 540.2
|
274.8 g/Kg of body weight
Interval 124.4 to 547.3
|
|
Body Composition (Body Fat)
Month 6 after supplement
|
181.9 g/Kg of body weight
Interval 98.0 to 535.0
|
298.2 g/Kg of body weight
Interval 120.7 to 567.2
|
PRIMARY outcome
Timeframe: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA).
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Lean Mass
Basal
|
774.7 g/kg of body weight
Interval 429.1 to 857.3
|
662.4 g/kg of body weight
Interval 413.3 to 841.4
|
|
Lean Mass
Month 1 after supplement
|
769.6 g/kg of body weight
Interval 427.0 to 846.0
|
647.7 g/kg of body weight
Interval 420.4 to 827.6
|
|
Lean Mass
Month 2 after supplement
|
772.4 g/kg of body weight
Interval 419.9 to 851.5
|
630.6 g/kg of body weight
Interval 420.1 to 827.4
|
|
Lean Mass
Month 3 after supplement
|
757.7 g/kg of body weight
Interval 421.0 to 838.7
|
627.7 g/kg of body weight
Interval 414.5 to 835.2
|
|
Lean Mass
Month 4 after supplement
|
755.7 g/kg of body weight
Interval 416.9 to 855.0
|
605.7 g/kg of body weight
Interval 414.0 to 823.6
|
|
Lean Mass
Month 5 after supplement
|
768.6 g/kg of body weight
Interval 423.6 to 829.8
|
617.7 g/kg of body weight
Interval 433.0 to 811.6
|
|
Lean Mass
Month 6 after supplement
|
766.7 g/kg of body weight
Interval 426.2 to 849.9
|
606.2 g/kg of body weight
Interval 398.1 to 813.1
|
PRIMARY outcome
Timeframe: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.We measured weight, height by anthropometric to calculate the body mass index (body mass index).
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Anthropometric Measurement: Body Mass Index
Basal
|
42.5 g/m^2
Interval 20.4 to 97.0
|
72.7 g/m^2
Interval 1.8 to 98.4
|
|
Anthropometric Measurement: Body Mass Index
Month 1 after supplement
|
48.2 g/m^2
Interval 9.6 to 97.2
|
78.3 g/m^2
Interval 3.9 to 98.7
|
|
Anthropometric Measurement: Body Mass Index
Month 2 after supplement
|
49.6 g/m^2
Interval 3.7 to 97.6
|
83.2 g/m^2
Interval 5.4 to 98.5
|
|
Anthropometric Measurement: Body Mass Index
Month 3 after supplement
|
47.4 g/m^2
Interval 15.3 to 97.2
|
82.2 g/m^2
Interval 4.8 to 97.7
|
|
Anthropometric Measurement: Body Mass Index
Month 4 after supplement
|
49.9 g/m^2
Interval 14.8 to 95.9
|
73.7 g/m^2
Interval 9.8 to 98.0
|
|
Anthropometric Measurement: Body Mass Index
Month 5 after supplement
|
47.4 g/m^2
Interval 3.4 to 96.5
|
75.3 g/m^2
Interval 7.7 to 98.1
|
|
Anthropometric Measurement: Body Mass Index
Month 6 after supplement
|
51.7 g/m^2
Interval 9.5 to 96.8
|
73.6 g/m^2
Interval 5.3 to 98.2
|
PRIMARY outcome
Timeframe: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Glucose in Serum
Basal
|
83.5 mg/dL
Interval 77.0 to 98.0
|
89.0 mg/dL
Interval 76.0 to 121.0
|
|
Glucose in Serum
Month 1 after supplement
|
84.5 mg/dL
Interval 79.0 to 98.0
|
90.0 mg/dL
Interval 81.0 to 98.0
|
|
Glucose in Serum
Month 2 after supplement
|
87.5 mg/dL
Interval 74.0 to 93.0
|
89.0 mg/dL
Interval 79.0 to 107.0
|
|
Glucose in Serum
Month 3 after supplement
|
84.0 mg/dL
Interval 61.0 to 95.0
|
86.8 mg/dL
Interval 79.5 to 99.0
|
|
Glucose in Serum
Month 4 after supplement
|
83.0 mg/dL
Interval 72.0 to 97.0
|
87.0 mg/dL
Interval 82.0 to 107.0
|
|
Glucose in Serum
Month 5 after supplement
|
84.0 mg/dL
Interval 76.0 to 99.0
|
89.8 mg/dL
Interval 75.0 to 99.0
|
|
Glucose in Serum
Month 6 after supplement
|
82.0 mg/dL
Interval 76.0 to 98.0
|
88.0 mg/dL
Interval 78.0 to 99.0
|
PRIMARY outcome
Timeframe: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA).
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Insulin in Blood
Basal
|
10.2 µU/mL
Interval 3.1 to 28.4
|
20.9 µU/mL
Interval 3.0 to 49.2
|
|
Insulin in Blood
Month 1 after supplement
|
11.2 µU/mL
Interval 5.5 to 38.5
|
17.8 µU/mL
Interval 4.0 to 55.0
|
|
Insulin in Blood
Month 2 after supplement
|
12.2 µU/mL
Interval 3.6 to 30.8
|
18.5 µU/mL
Interval 2.4 to 50.0
|
|
Insulin in Blood
Month 3 after supplement
|
11.4 µU/mL
Interval 3.2 to 34.1
|
18.0 µU/mL
Interval 3.8 to 53.3
|
|
Insulin in Blood
Month 4 after supplement
|
9.2 µU/mL
Interval 2.0 to 24.2
|
21.0 µU/mL
Interval 3.9 to 60.0
|
|
Insulin in Blood
Month 5 after supplement
|
8.9 µU/mL
Interval 2.3 to 25.9
|
17.7 µU/mL
Interval 4.2 to 69.6
|
|
Insulin in Blood
Month 6 after supplement
|
10.6 µU/mL
Interval 1.5 to 28.9
|
18.8 µU/mL
Interval 1.9 to 61.6
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.Plasma cytokine TNF-A was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Inflammation Biomarkers (TNF-A)
Month 1 after supplement
|
8.77 percentage of change respect at basal
Standard Deviation 50.01
|
-1.45 percentage of change respect at basal
Standard Deviation 37.47
|
|
Inflammation Biomarkers (TNF-A)
Month 2 after supplement
|
-22.04 percentage of change respect at basal
Standard Deviation 28.04
|
-21.01 percentage of change respect at basal
Standard Deviation 37.69
|
|
Inflammation Biomarkers (TNF-A)
Month 3 after supplement
|
-43.79 percentage of change respect at basal
Standard Deviation 32.69
|
-37.76 percentage of change respect at basal
Standard Deviation 29.69
|
|
Inflammation Biomarkers (TNF-A)
Month 6 after supplement
|
-65.78 percentage of change respect at basal
Standard Deviation 26.62
|
-60.56 percentage of change respect at basal
Standard Deviation 18.77
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Inflammation Biomarkers (IL-1)
Month 1 after supplement
|
2.05 percentage of change respect at basal
Standard Deviation 53.77
|
21.74 percentage of change respect at basal
Standard Deviation 60.76
|
|
Inflammation Biomarkers (IL-1)
Month 2 after supplement
|
-6.00 percentage of change respect at basal
Standard Deviation 60.69
|
-2.49 percentage of change respect at basal
Standard Deviation 76.14
|
|
Inflammation Biomarkers (IL-1)
Month 3 after supplement
|
-43.84 percentage of change respect at basal
Standard Deviation 34.96
|
-9.89 percentage of change respect at basal
Standard Deviation 63.68
|
|
Inflammation Biomarkers (IL-1)
Month 6 after supplement
|
-57.04 percentage of change respect at basal
Standard Deviation 31.56
|
-10.97 percentage of change respect at basal
Standard Deviation 70.95
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.Plasma cytokine IL-6 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Inflammation Biomarkers (IL-6)
Month 1 after supplement
|
0.60 percentage of change respect at basal
Standard Deviation 43.80
|
0.08 percentage of change respect at basal
Standard Deviation 63.76
|
|
Inflammation Biomarkers (IL-6)
Month 2 after supplement
|
-10.57 percentage of change respect at basal
Standard Deviation 44.95
|
-3.6 percentage of change respect at basal
Standard Deviation 41.66
|
|
Inflammation Biomarkers (IL-6)
Month 3 after supplement
|
-29.33 percentage of change respect at basal
Standard Deviation 35.17
|
-16.61 percentage of change respect at basal
Standard Deviation 46.39
|
|
Inflammation Biomarkers (IL-6)
Month 6 after supplement
|
-52.33 percentage of change respect at basal
Standard Deviation 20.89
|
-24.83 percentage of change respect at basal
Standard Deviation 48.15
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Inflammation Biomarkers (IL-10)
Month 2 after supplement
|
4.83 percentage of change respect at basal
Standard Deviation 114.65
|
-21.16 percentage of change respect at basal
Standard Deviation 50.03
|
|
Inflammation Biomarkers (IL-10)
Month 3 after supplement
|
46.49 percentage of change respect at basal
Standard Deviation 171.49
|
-39.91 percentage of change respect at basal
Standard Deviation 32.72
|
|
Inflammation Biomarkers (IL-10)
Month 1 after supplement
|
27.66 percentage of change respect at basal
Standard Deviation 115.80
|
-8.89 percentage of change respect at basal
Standard Deviation 68.42
|
|
Inflammation Biomarkers (IL-10)
Month 6 after supplement
|
108.85 percentage of change respect at basal
Standard Deviation 173.87
|
-41.21 percentage of change respect at basal
Standard Deviation 52.60
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.The messenger ribonucleic acid (mRNA) expression of cytokines IL-6 from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR).
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Inflammation Biomarker (IL-6 Expression)
Basal
|
2.27 percentage of change respect at basal
Standard Deviation 2.7
|
2.45 percentage of change respect at basal
Standard Deviation 2.45
|
|
Inflammation Biomarker (IL-6 Expression)
Month 1 after supplement
|
1.26 percentage of change respect at basal
Standard Deviation 1.95
|
5.33 percentage of change respect at basal
Standard Deviation 4.47
|
|
Inflammation Biomarker (IL-6 Expression)
Month 2 after supplement
|
1.7 percentage of change respect at basal
Standard Deviation 0.88
|
7.82 percentage of change respect at basal
Standard Deviation 4.44
|
|
Inflammation Biomarker (IL-6 Expression)
Month 3 after supplement
|
0.6 percentage of change respect at basal
Standard Deviation 0.26
|
3.5 percentage of change respect at basal
Standard Deviation 2.72
|
|
Inflammation Biomarker (IL-6 Expression)
Month 6 after supplement
|
0.77 percentage of change respect at basal
Standard Deviation 0.39
|
9.5 percentage of change respect at basal
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.The messenger ribonucleic acid (mRNA) expression of cytokines TNF-A from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR)
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Inflammation Biomarker (TNF-A Expression)
Month 1 after supplement
|
2.07 percentage of change respect at basal
Standard Deviation 2.6
|
1.05 percentage of change respect at basal
Standard Deviation 0.94
|
|
Inflammation Biomarker (TNF-A Expression)
Month 2 after supplement
|
1.3 percentage of change respect at basal
Standard Deviation 2.07
|
2.12 percentage of change respect at basal
Standard Deviation 0.93
|
|
Inflammation Biomarker (TNF-A Expression)
Basal
|
1.82 percentage of change respect at basal
Standard Deviation 2.6
|
1.15 percentage of change respect at basal
Standard Deviation 0.63
|
|
Inflammation Biomarker (TNF-A Expression)
Month 3 after supplement
|
1.05 percentage of change respect at basal
Standard Deviation 2.0
|
2.27 percentage of change respect at basal
Standard Deviation 3.11
|
|
Inflammation Biomarker (TNF-A Expression)
Month 6 after supplement
|
1.25 percentage of change respect at basal
Standard Deviation 1.43
|
0.52 percentage of change respect at basal
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.The messenger ribonucleic acid (mRNA) expression of cytokines IL-1 was determined by quantifying the real-time polymerase chain reaction (PCR).
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Inflammation Biomarker (IL-1 Expression)
Basal
|
1.22 percentage of change respect at basal
Standard Deviation 0.96
|
1.7 percentage of change respect at basal
Standard Deviation 1.78
|
|
Inflammation Biomarker (IL-1 Expression)
Month 1 after supplement
|
0.93 percentage of change respect at basal
Standard Deviation 1.24
|
1.08 percentage of change respect at basal
Standard Deviation 1.02
|
|
Inflammation Biomarker (IL-1 Expression)
Month 2 after supplement
|
0.69 percentage of change respect at basal
Standard Deviation 0.51
|
0.86 percentage of change respect at basal
Standard Deviation 0.41
|
|
Inflammation Biomarker (IL-1 Expression)
Month 3 after supplement
|
0.29 percentage of change respect at basal
Standard Deviation 0.16
|
0.66 percentage of change respect at basal
Standard Deviation 0.46
|
|
Inflammation Biomarker (IL-1 Expression)
Month 6 after supplement
|
0.47 percentage of change respect at basal
Standard Deviation 0.4
|
1.93 percentage of change respect at basal
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Markers of Muscle Degeneration (Creatinine Kinase)
Month 1 after supplement
|
23.30 percentage of change respect at basal
Standard Deviation 38.56
|
8.82 percentage of change respect at basal
Standard Deviation 52.59
|
|
Markers of Muscle Degeneration (Creatinine Kinase)
Month 2 after supplement
|
30.10 percentage of change respect at basal
Standard Deviation 58.23
|
-9.95 percentage of change respect at basal
Standard Deviation 55.82
|
|
Markers of Muscle Degeneration (Creatinine Kinase)
Month 3 after supplement
|
8.45 percentage of change respect at basal
Standard Deviation 38.24
|
0.75 percentage of change respect at basal
Standard Deviation 44.76
|
|
Markers of Muscle Degeneration (Creatinine Kinase)
Month 6 after supplement
|
4.46 percentage of change respect at basal
Standard Deviation 42.67
|
-1.52 percentage of change respect at basal
Standard Deviation 33.98
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 of supplementation.Plasma matrix metalloproteinase 9 (MMP9) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in ng/mL.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Markers of Muscle Degeneration (MMP9)
Month 3 after supplement
|
-21.2 percentage of change respect at basal
Interval -61.9 to 92.0
|
53.5 percentage of change respect at basal
Interval -59.1 to 526.6
|
|
Markers of Muscle Degeneration (MMP9)
Month 6 after supplement
|
-23.6 percentage of change respect at basal
Interval -58.0 to 37.3
|
39.9 percentage of change respect at basal
Interval -40.1 to 443.0
|
|
Markers of Muscle Degeneration (MMP9)
Month 1 after supplement
|
-31.5 percentage of change respect at basal
Interval -84.0 to 58.5
|
-13.0 percentage of change respect at basal
Interval -74.4 to 168.4
|
|
Markers of Muscle Degeneration (MMP9)
Month 2 after supplement
|
-3.5 percentage of change respect at basal
Interval -58.8 to 315.6
|
47.7 percentage of change respect at basal
Interval -73.0 to 274.2
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.The concentration in plasma of soluble Fas (sFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Markers of Muscle Degeneration (sFas)
Month 1 after supplement
|
11.1 percentage of change respect at basal
Interval -87.4 to 33.0
|
15.8 percentage of change respect at basal
Interval -49.8 to 89.5
|
|
Markers of Muscle Degeneration (sFas)
Month 2 after supplement
|
14.2 percentage of change respect at basal
Interval -89.0 to 53.5
|
15.8 percentage of change respect at basal
Interval -29.7 to 67.2
|
|
Markers of Muscle Degeneration (sFas)
Month 3 after supplement
|
7.2 percentage of change respect at basal
Interval -88.8 to 47.1
|
14.5 percentage of change respect at basal
Interval -53.5 to 89.7
|
|
Markers of Muscle Degeneration (sFas)
Month 6 after supplement
|
18.3 percentage of change respect at basal
Interval -89.5 to 157.7
|
20.7 percentage of change respect at basal
Interval -34.7 to 51.2
|
SECONDARY outcome
Timeframe: At baseline and at months 1, 2, 3 and 6 of supplementation.The concentration in plasma of the receptor o Fas (rFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Markers of Muscle Degeneration (Receptor of Fas)
Month 1 after supplement
|
16.5 percentage of change respect at basal
Interval -45.3 to 95.7
|
-2.0 percentage of change respect at basal
Interval -62.5 to 5.0
|
|
Markers of Muscle Degeneration (Receptor of Fas)
Month 2 after supplement
|
2.4 percentage of change respect at basal
Interval -54.3 to 47.7
|
-10.1 percentage of change respect at basal
Interval -56.5 to 15.4
|
|
Markers of Muscle Degeneration (Receptor of Fas)
Month 3 after supplement
|
-15.7 percentage of change respect at basal
Interval -44.2 to 28.8
|
-16.3 percentage of change respect at basal
Interval -58.5 to 49.7
|
|
Markers of Muscle Degeneration (Receptor of Fas)
Month 6 after supplement
|
-16.5 percentage of change respect at basal
Interval -54.4 to 14.9
|
-30.0 percentage of change respect at basal
Interval -61.2 to 30.9
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Markers of Muscle Regeneration (VEGF)
Month 3 after supplement
|
-15.7 percentage of change respect at basal
Interval -44.2 to 28.8
|
-16.3 percentage of change respect at basal
Interval -58.5 to 49.7
|
|
Markers of Muscle Regeneration (VEGF)
Month 6 after supplement
|
-15.9 percentage of change respect at basal
Interval -40.0 to 26.9
|
14.3 percentage of change respect at basal
Interval -39.0 to 42.6
|
|
Markers of Muscle Regeneration (VEGF)
Month 1 after supplement
|
-25.9 percentage of change respect at basal
Interval -89.6 to 75.3
|
-5.7 percentage of change respect at basal
Interval -75.3 to 182.1
|
|
Markers of Muscle Regeneration (VEGF)
Month 2 after supplement
|
2.4 percentage of change respect at basal
Interval -47.0 to 123.3
|
-9.5 percentage of change respect at basal
Interval -46.3 to 169.0
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.Plasma marker of regeneration fibroblast growth factor basic (FGF) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Markers of Muscle Regeneration (FGF)
Month 1 after supplement
|
-13.6 percentage of change respect at basal
Interval -76.2 to 133.6
|
-37.3 percentage of change respect at basal
Interval -79.7 to 50.2
|
|
Markers of Muscle Regeneration (FGF)
Month 2 after supplement
|
2.4 percentage of change respect at basal
Interval -47.0 to 123.3
|
-9.5 percentage of change respect at basal
Interval -46.3 to 169.0
|
|
Markers of Muscle Regeneration (FGF)
Month 3 after supplement
|
-0.92 percentage of change respect at basal
Interval -69.8 to 186.2
|
-57.1 percentage of change respect at basal
Interval -89.2 to 81.9
|
|
Markers of Muscle Regeneration (FGF)
Month 6 after supplement
|
-28.0 percentage of change respect at basal
Interval -87.0 to 18.0
|
-70.9 percentage of change respect at basal
Interval -80.0 to 20.8
|
SECONDARY outcome
Timeframe: Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Incorporation of DHA in the Erythrocytes
Month 1 after supplement
|
57.8 percentage of change respect at basal
Interval -34.4 to 721.9
|
0.9 percentage of change respect at basal
Interval -79.0 to 77.2
|
|
Incorporation of DHA in the Erythrocytes
Month 2 after supplement
|
31.1 percentage of change respect at basal
Interval -63.2 to 364.1
|
-2.1 percentage of change respect at basal
Interval -78.9 to 98.5
|
|
Incorporation of DHA in the Erythrocytes
Month 3 after supplement
|
153.4 percentage of change respect at basal
Interval -43.7 to 1385.8
|
-17.4 percentage of change respect at basal
Interval -89.9 to 96.0
|
|
Incorporation of DHA in the Erythrocytes
Month 4 after supplement
|
247.6 percentage of change respect at basal
Interval -49.5 to 1100.6
|
5.6 percentage of change respect at basal
Interval -59.4 to 76.6
|
|
Incorporation of DHA in the Erythrocytes
Month 5 after supplement
|
116.6 percentage of change respect at basal
Interval -35.2 to 1163.8
|
-0.6 percentage of change respect at basal
Interval -77.7 to 125.2
|
|
Incorporation of DHA in the Erythrocytes
Month 6 after supplement
|
289.4 percentage of change respect at basal
Interval -82.7 to 2117.6
|
-1.5 percentage of change respect at basal
Interval -73.8 to 79.9
|
SECONDARY outcome
Timeframe: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography.
Outcome measures
| Measure |
EPA and DHA
n=17 Participants
Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U
|
Sunflower Oil
n=19 Participants
Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg
|
|---|---|---|
|
Incorporation of EPA in the Erythrocytes
Month 6 after supplement
|
446.4 percentage of change respect at basal
Interval -51.8 to 1174.4
|
-53.1 percentage of change respect at basal
Interval -77.2 to 20.2
|
|
Incorporation of EPA in the Erythrocytes
Month 1 after supplement
|
233.0 percentage of change respect at basal
Interval 4.0 to 604.7
|
-11.8 percentage of change respect at basal
Interval -87.63 to 18.8
|
|
Incorporation of EPA in the Erythrocytes
Month 2 after supplement
|
300.4 percentage of change respect at basal
Interval -10.7 to 656.3
|
-11.5 percentage of change respect at basal
Interval -87.6 to 274.0
|
|
Incorporation of EPA in the Erythrocytes
Month 3 after supplement
|
552.6 percentage of change respect at basal
Interval 168.6 to 1185.1
|
-19.5 percentage of change respect at basal
Interval -91.0 to 96.9
|
|
Incorporation of EPA in the Erythrocytes
Month 4 after supplement
|
552.7 percentage of change respect at basal
Interval -86.7 to 999.3
|
-20.9 percentage of change respect at basal
Interval -80.2 to 14.4
|
|
Incorporation of EPA in the Erythrocytes
Month 5 after supplement
|
480.6 percentage of change respect at basal
Interval 23.4 to 2356.3
|
-5.4 percentage of change respect at basal
Interval -81.0 to 92.6
|
Adverse Events
EPA and DHA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sunflower Oil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EPA and DHA
n=18 participants at risk
Supplementation of 2.9 g / d of EPA and DHA will be provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade.
EPA and DHA: Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U.
|
Sunflower Oil
n=22 participants at risk
Supplementation of placebo with sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process. This placebo is sunflower oil and so will not expected to produce anti-inflammatory or insulin sensitivity effects.
Placebo Comparator: Sunflower oil; the placebo capsules will also contain sunflower oil. Each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting and diarrhea
|
5.6%
1/18 • Number of events 1 • One patient presented vomiting and diarrhea, the patient had three evacuations during the night in a period of 3 hours and vomiting occurred for a period of 10 minutes. These complications occurred only once in the first month of supplementation.
|
0.00%
0/22 • One patient presented vomiting and diarrhea, the patient had three evacuations during the night in a period of 3 hours and vomiting occurred for a period of 10 minutes. These complications occurred only once in the first month of supplementation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place