Trial Outcomes & Findings for Oxidized Omega-3 Supplements With Different Oxidation (NCT NCT01799720)
NCT ID: NCT01799720
Last Updated: 2015-08-03
Results Overview
In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Days 1 and 30
Results posted on
2015-08-03
Participant Flow
The place where women were recruited for our study was a pharmacy located in the city centre of Elche, during October 2010. Elche is an industrial city located in the Southeast of Spain, with a population of 230 000 inhabitants.
Before the survey began, 14 people were discarded from the survey because their cholesterol levels were lower than the inclusion standards. 5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.
Participant milestones
| Measure |
Less Oxidized Oil and Diet
Participants from group 1 took 2 capsules a day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
|
More Oxidized Oil and Diet
Participants from group 2 took 2 capsules a day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
|
Diet
Participants from group 3 took only diet, Follow-up 30 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
19
|
|
Overall Study
Began the Treatment
|
20
|
18
|
19
|
|
Overall Study
Began the Treatment and Finished it
|
17
|
17
|
18
|
|
Overall Study
COMPLETED
|
17
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
Less Oxidized Oil and Diet
Participants from group 1 took 2 capsules a day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
|
More Oxidized Oil and Diet
Participants from group 2 took 2 capsules a day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
|
Diet
Participants from group 3 took only diet, Follow-up 30 days
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
Baseline Characteristics
Oxidized Omega-3 Supplements With Different Oxidation
Baseline characteristics by cohort
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Only Diet
n=18 Participants
Participants from group 3 only received the diet. Follow-up 30 days.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Continuous
|
56.65 years
STANDARD_DEVIATION 12.65 • n=5 Participants
|
56.82 years
STANDARD_DEVIATION 12.18 • n=7 Participants
|
51.94 years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
55.14 years
STANDARD_DEVIATION 11.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
18 participants
n=5 Participants
|
52 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 30In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Day 1
|
70.17 kilogram
Standard Error 3.71
|
68.77 kilogram
Standard Error 3.42
|
75.15 kilogram
Standard Error 3.95
|
|
Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Day 30
|
69.38 kilogram
Standard Error 3.61
|
67.78 kilogram
Standard Error 3.41
|
74.29 kilogram
Standard Error 3.94
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the height of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 1
|
1.60 metres
Standard Error 0.02
|
1.59 metres
Standard Error 0.01
|
1.61 metres
Standard Error 0.01
|
|
Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 30
|
1.60 metres
Standard Error 0.02
|
1.59 metres
Standard Error 0.01
|
1.61 metres
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 30
|
27.10 kilogram / square metre
Standard Error 1.34
|
26.94 kilogram / square metre
Standard Error 1.36
|
28.64 kilogram / square metre
Standard Error 1.45
|
|
Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 1
|
27.43 kilogram / square metre
Standard Error 1.41
|
28.65 kilogram / square metre
Standard Error 2.13
|
29.00 kilogram / square metre
Standard Error 1.50
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Day 1
|
86.5 ratio*100
Standard Error 2.1
|
87.2 ratio*100
Standard Error 3.0
|
86.0 ratio*100
Standard Error 2.9
|
|
Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Day 30
|
86.5 ratio*100
Standard Error 2.1
|
87.2 ratio*100
Standard Error 3.0
|
86.0 ratio*100
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 1
|
129.9 millimetres of mercury
Standard Error 0.50
|
123.7 millimetres of mercury
Standard Error 0.66
|
118.6 millimetres of mercury
Standard Error 0.37
|
|
Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 30
|
118.2 millimetres of mercury
Standard Error 0.42
|
120.2 millimetres of mercury
Standard Error 0.41
|
119.4 millimetres of mercury
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 30
|
68.9 millimetres of mercury
Standard Error 0.21
|
75.1 millimetres of mercury
Standard Error 0.29
|
72.8 millimetres of mercury
Standard Error 0.20
|
|
Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 1
|
77.2 millimetres of mercury
Standard Error 0.26
|
73.9 millimetres of mercury
Standard Error 0.34
|
73.3 millimetres of mercury
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 1
|
103.35 milligram / decilitre
Standard Error 3.18
|
108.96 milligram / decilitre
Standard Error 11.11
|
99.72 milligram / decilitre
Standard Error 4.53
|
|
Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 30
|
116.24 milligram / decilitre
Standard Error 4.30
|
111.37 milligram / decilitre
Standard Error 2.46
|
108.26 milligram / decilitre
Standard Error 2.55
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 1
|
246.64 milligram / decilitre
Standard Error 12.92
|
232.94 milligram / decilitre
Standard Error 12.55
|
236.78 milligram / decilitre
Standard Error 4.17
|
|
Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 30
|
217.76 milligram / decilitre
Standard Error 8.98
|
237.52 milligram / decilitre
Standard Error 7.54
|
227.22 milligram / decilitre
Standard Error 6.02
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 1
|
164.41 milligram / decilitre
Standard Error 15.43
|
160.41 milligram / decilitre
Standard Error 11.34
|
174.83 milligram / decilitre
Standard Error 19.83
|
|
Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 30
|
125.52 milligram / decilitre
Standard Error 12.34
|
116.88 milligram / decilitre
Standard Error 11.43
|
130.04 milligram / decilitre
Standard Error 10.18
|
SECONDARY outcome
Timeframe: Days 1 and 30In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.
Outcome measures
| Measure |
Less Oxidized Oil and Diet
n=17 Participants
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=17 Participants
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=18 Participants
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 1
|
22.70 Units / litre
Standard Error 2.71
|
24.90 Units / litre
Standard Error 2.96
|
23.54 Units / litre
Standard Error 3.92
|
|
Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Day 30
|
20.69 Units / litre
Standard Error 3.34
|
18.46 Units / litre
Standard Error 1.62
|
19.94 Units / litre
Standard Error 2.19
|
Adverse Events
Less Oxidized Oil and Diet
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
More Oxidized Oil and Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Less Oxidized Oil and Diet
n=20 participants at risk
Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
More Oxidized Oil and Diet
n=18 participants at risk
Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
|
Diet
n=19 participants at risk
Participants from group 3 only took diet. Follow-up 30 days.
|
|---|---|---|---|
|
Investigations
Violation of protocol norms
|
0.00%
0/20
5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.
|
0.00%
0/18
5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.
|
5.3%
1/19
5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.
|
|
Social circumstances
Study abandonment
|
15.0%
3/20
5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.
|
0.00%
0/18
5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.
|
0.00%
0/19
5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place