- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03059836
n3 PUFA and Muscle-disuse Atrophy in Young Women
Effects of n3 PUFA Supplementation on the Attenuation of Muscle Disuse Atrophy in Young Women
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Biological aging is associated with the loss of skeletal muscle mass and strength resulting in compromised metabolic function and mobility. Throughout life, individuals will also experience periods of reduced physical activity/muscle disuse that independently lower muscle mass and strength accelerating the aging process. The losses in muscle mass with aging and disuse are underpinned by feeding-induced declines in rates of muscle protein synthesis. Thus, strategies to enhance muscle protein synthesis could have clinical implications for those who wish to maintain metabolic health and function during times of muscle disuse.
Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle protein synthesis in response to simulated feeding in both younger and older adults. Fish oil supplementation also has been efficacious in enhancing skeletal muscle strength during a period of resistance exercise training. However, no study has examined the impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in muscle mass/strength during a period of immobilization.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Exercise Metabolism Research Laboratory, McMaster Univeristy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Female
- Aged 18-30 years
Exclusion Criteria:
- Take any analgesic or anti-inflammatory drugs(s), prescription or non-prescription, chronically will be excluded
- A history of neuromuscular problems or muscle and/or bone wasting diseases
- Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires
- Use medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)
- Fish allergy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: n3 PUFA
Intervention: n3 PUFA (3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day)
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3000mg eikosapentaensyre per dag og 1800mg dokosaheksaensyre per dag
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Placebo komparator: Placebo
Intervention: Organic Sunflower Oil 5000mg per day
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Økologisk solsikkeolje 5000mg per dag
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Muscle Volume
Tidsramme: Baseline (0 days), After (14 days) of unilateral limb immobilization and at 14 days post immobilization
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Change in Muscle Volume Measured by Magnetic Resonance Imaging
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Baseline (0 days), After (14 days) of unilateral limb immobilization and at 14 days post immobilization
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Integrated Rates of Muscle Protein Synthesis
Tidsramme: Before (0 days), During (0-14 days inclusive), and After (14-28 days inclusive) of unilateral limb immobilization
|
Change in Muscle Protein Synthesis
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Before (0 days), During (0-14 days inclusive), and After (14-28 days inclusive) of unilateral limb immobilization
|
Skeletal Muscle Strength
Tidsramme: Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
|
Change in Skeletal Muscle Strength
|
Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
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Muscle Lipid Composition
Tidsramme: Baseline (-28 days), and at Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
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Change in Muscle Lipid Composition
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Baseline (-28 days), and at Before (0 days), After (14 days) of unilateral limb immobilization and at 14 days Post immobilization
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1457
Plan for individuelle deltakerdata (IPD)
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