Trial Outcomes & Findings for Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate (NCT NCT02092649)
NCT ID: NCT02092649
Last Updated: 2016-01-06
Results Overview
Percent change in resting metabolic rate
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Baseline, 6 weeks, 12 weeks
Results posted on
2016-01-06
Participant Flow
Recruitment period: May 2014 - Dec 2014 Location: University of Guelph
Participant milestones
| Measure |
Omega-3 Complete
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete
|
Placebo Pill
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate
Baseline characteristics by cohort
| Measure |
Omega-3 Complete
n=13 Participants
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete
|
Placebo Pill
n=13 Participants
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill
|
Total
n=26 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
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 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
|
23 years
STANDARD_DEVIATION 3.29 • n=5 Participants
|
22 years
STANDARD_DEVIATION 1.61 • n=7 Participants
|
23 years
STANDARD_DEVIATION 2.57 • 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
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Resting Metabolic Rate
|
2041 kcal/day
STANDARD_DEVIATION 187 • n=5 Participants
|
2016 kcal/day
STANDARD_DEVIATION 227 • n=7 Participants
|
2029 kcal/day
STANDARD_DEVIATION 204 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPercent change in resting metabolic rate
Outcome measures
| Measure |
Omega-3 Complete
n=13 Participants
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete
|
Placebo Pill
n=13 Participants
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill
|
|---|---|---|
|
Change in Resting Metabolic Rate From Baseline
Baseline - Week 6
|
-0.19 percent change
Standard Deviation 4.70
|
-0.19 percent change
Standard Deviation 4.70
|
|
Change in Resting Metabolic Rate From Baseline
Baseline - Week 12
|
0.67 percent change
Standard Deviation 8.65
|
1.11 percent change
Standard Deviation 6.51
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksOutcome measures
| Measure |
Omega-3 Complete
n=13 Participants
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete
|
Placebo Pill
n=13 Participants
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill
|
|---|---|---|
|
Change in Maximum Oxygen Consumption From Baseline
|
3.30 percent change
Standard Deviation 5.54
|
2.17 percent change
Standard Deviation 5.52
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksOutcome measures
| Measure |
Omega-3 Complete
n=13 Participants
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete
|
Placebo Pill
n=13 Participants
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill
|
|---|---|---|
|
Change in Whole Body Resting Fat Oxidation From Baseline
Baseline - Week 6
|
0.39 percent change
Standard Deviation 34.53
|
2.92 percent change
Standard Deviation 31.37
|
|
Change in Whole Body Resting Fat Oxidation From Baseline
Baseline - Week 12
|
19.52 percent change
Standard Deviation 38.39
|
17.82 percent change
Standard Deviation 48.56
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksOutcome measures
| Measure |
Omega-3 Complete
n=13 Participants
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete
|
Placebo Pill
n=13 Participants
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill
|
|---|---|---|
|
Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Baseline - Week 6
|
-3.47 percent change
Standard Deviation 42.05
|
7.23 percent change
Standard Deviation 32.64
|
|
Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Baseline - Week 12
|
-12.41 percent change
Standard Deviation 39.15
|
14.23 percent change
Standard Deviation 42.86
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksOutcome measures
| Measure |
Omega-3 Complete
n=13 Participants
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete
|
Placebo Pill
n=13 Participants
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill
|
|---|---|---|
|
Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Week 0
|
2.70 percent variability
Standard Deviation 2.44
|
2.57 percent variability
Standard Deviation 1.32
|
|
Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Week 6
|
3.98 percent variability
Standard Deviation 3.30
|
2.77 percent variability
Standard Deviation 2.04
|
|
Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Week 12
|
3.22 percent variability
Standard Deviation 2.97
|
2.18 percent variability
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksOutcome measures
| Measure |
Omega-3 Complete
n=12 Participants
Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.
Omega-3 Complete
|
Placebo Pill
n=12 Participants
Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.
Placebo Pill
|
|---|---|---|
|
Change in Fasted Blood Triglyceride Concentration From Baseline
|
-18.07 percent change
Standard Deviation 44.44
|
-2.41 percent change
Standard Deviation 60.00
|
Adverse Events
Omega-3 Complete
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place