- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ontario
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Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Oméga-3 Complet
Ingestion orale de 3000 mg (5 capsules) d'Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) par jour pendant 12 semaines.
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Comparateur placebo: Pilule placebo
Ingestion orale de 3 capsules d'une pilule d'huile d'olive placebo (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) par jour pendant 12 semaines.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Resting Metabolic Rate From Baseline
Délai: Baseline, 6 weeks, 12 weeks
|
Percent change in resting metabolic rate
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Baseline, 6 weeks, 12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in Maximum Oxygen Consumption From Baseline
Délai: Baseline, 12 weeks
|
Baseline, 12 weeks
|
|
Change in Whole Body Resting Fat Oxidation From Baseline
Délai: Baseline, 6 weeks, 12 weeks
|
Baseline, 6 weeks, 12 weeks
|
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Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Délai: Baseline, 6 weeks, 12 weeks
|
Baseline, 6 weeks, 12 weeks
|
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Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days
Délai: Baseline, 6 weeks, 12 weeks
|
Baseline, 6 weeks, 12 weeks
|
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Change in Fasted Blood Triglyceride Concentration From Baseline
Délai: Baseline, 12 weeks
|
Baseline, 12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 14JA044
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