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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 3 months, 5 months

Results posted on

2017-04-05

Participant Flow

Participant milestones

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).
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

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.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
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
12 Participants
n=5 Participants
Triglycerides
0.9 mmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months, 5 months

Population: 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

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
Blood Triglyceride
5 months
0.9 mmol/L
Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline, 3 months, 5 months

Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.

Outcome measures

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 519-824-4120

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place