Trial Outcomes & Findings for Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health (NCT NCT02042274)
NCT ID: NCT02042274
Last Updated: 2017-04-05
Results Overview
Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
COMPLETED
NA
12 participants
Baseline, 3 months, 5 months
2017-04-05
Participant Flow
Participant milestones
| Measure |
Fish Oil Supplement
Fish oil supplements providing up to 3g per day of EPA and DHA
Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
Measurements are made at three time points: Baseline (Day 0 - before beginning fish oil supplementation), 3 months (Day 90 - after fish oil supplementation), and 5 months (Day 150 - 2 month washout).
|
|---|---|
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Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health
Baseline characteristics by cohort
| Measure |
Fish Oil
n=12 Participants
Fish oil supplements providing up to 3g per day of EPA and DHA, for 90 days.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
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12 Participants
n=5 Participants
|
|
Triglycerides
|
0.9 mmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, 3 months, 5 monthsPopulation: Healthy adults, ranging in age from 18-65 years.
Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
Outcome measures
| Measure |
Fish Oil Supplement
n=12 Participants
Fish oil supplements providing up to 3g per day of EPA and DHA
Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
|
|---|---|
|
Blood Triglyceride
Baseline
|
0.9 mmol/L
Standard Deviation 0.3
|
|
Blood Triglyceride
3 Months
|
0.8 mmol/L
Standard Deviation 0.3
|
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Blood Triglyceride
5 months
|
0.9 mmol/L
Standard Deviation 0.5
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SECONDARY outcome
Timeframe: Baseline, 3 months, 5 monthsBlood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.
Outcome measures
| Measure |
Fish Oil Supplement
n=12 Participants
Fish oil supplements providing up to 3g per day of EPA and DHA
Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
|
|---|---|
|
Blood Glucose
Baseline
|
4.4 mmol/L
Standard Deviation 1.4
|
|
Blood Glucose
3 Months
|
3.9 mmol/L
Standard Deviation 1.3
|
|
Blood Glucose
5 months
|
4.2 mmol/L
Standard Deviation 1.4
|
Adverse Events
Fish Oil Supplement
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Mutch, Associate Professor
University of Guelph
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place