- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02092649
Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate
Fatty acids are the main components of the cell membranes. It has been demonstrated that diet can alter the characteristics and function of many membranes in the body, which has an effect on cardiovascular and metabolic health. Over the last two decades there has been a substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on bodily function. There are two fatty acids that are of particular interest to researchers, eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique unsaturated structures, and their incorporation into biological membranes seems to generate important and positive physiological effects. The body is unable to synthesize these fatty acids in high concentrations to elicit significant effects, so they must be obtained through diet in food or via supplementation.
It has been suggested that EPA and DHA supplementation increases resting metabolic rate (RMR) in humans, in part by increasing the use of fat as a fuel during rest. There are a limited number of studies examining the effects of Omega 3 supplementation on RMR. Some have found an increase in RMR while others have found no change. These studies have some limitations, as that they have either used a small sample size, a low omega fatty acid dose and/or short supplementation periods. Due to the variable results, the investigators will improve the reliability of the RMR measurements by making measures on each subject during two consecutive days at each time point that it is measured (0, 6 and 12 weeks).
Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3 supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR and fat oxidation in some subjects and not in others. The duplicate RMR measures will determine the prevalence and magnitude of the omega 3 supplementation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ontario
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Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 - 30 years of age.
- Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study.
Exclusion Criteria:
- Current or previous supplementation with omega-3's.
- Average fish intake greater than two times per week.
- Taken any medications, have any medical condition, and hospitalization or surgeries.
- Allergy to fish/fish oil, , (rosemary extract, ascorbyl palmitate, or natural tocopherols).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Omega-3 komplet
Oral indtagelse af 3000 mg (5 kapsler) Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) om dagen i 12 uger.
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Placebo komparator: Placebo pille
Oral indtagelse af 3 kapsler af en placebo-olivenoliepille (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) om dagen i 12 uger.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Resting Metabolic Rate From Baseline
Tidsramme: Baseline, 6 weeks, 12 weeks
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Percent change in resting metabolic rate
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Baseline, 6 weeks, 12 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in Maximum Oxygen Consumption From Baseline
Tidsramme: Baseline, 12 weeks
|
Baseline, 12 weeks
|
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Change in Whole Body Resting Fat Oxidation From Baseline
Tidsramme: Baseline, 6 weeks, 12 weeks
|
Baseline, 6 weeks, 12 weeks
|
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Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Tidsramme: Baseline, 6 weeks, 12 weeks
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Baseline, 6 weeks, 12 weeks
|
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Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Tidsramme: Baseline, 6 weeks, 12 weeks
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Baseline, 6 weeks, 12 weeks
|
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Change in Fasted Blood Triglyceride Concentration From Baseline
Tidsramme: Baseline, 12 weeks
|
Baseline, 12 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 14JA044
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