- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ontario
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Guelph, Ontario, Kanada, N1G 2W1
- University of Guelph
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Omega-3 komplett
Orale Einnahme von 3000 mg (5 Kapseln) Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Kanada) pro Tag über 12 Wochen.
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Placebo-Komparator: Placebo-Pille
Orale Einnahme von 3 Kapseln einer Placebo-Olivenölpille (Swanson Health Products, PO Box 2803 – Fargo, ND 58108 USA) pro Tag über 12 Wochen.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Resting Metabolic Rate From Baseline
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Change in Maximum Oxygen Consumption From Baseline
Zeitfenster: Baseline, 12 weeks
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Baseline, 12 weeks
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Change in Whole Body Resting Fat Oxidation From Baseline
Zeitfenster: Baseline, 6 weeks, 12 weeks
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Baseline, 6 weeks, 12 weeks
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Change in Whole Body Resting Carbohydrate Oxidation From Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, 12 weeks
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Baseline, 12 weeks
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 14JA044
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