Fish Oil and Muscle Function
8. desember 2014 oppdatert av: Washington University School of Medicine
Omega-3 Fatty Acids, Muscle Mass and Muscle Function
The purpose of this study is to examine the effect of omega-3 fatty acid supplementation on changes in muscle mass, muscular strength and physical function.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Loss of muscle mass is a normal consequence of aging in many older adults, worsened by chronic illness, poor appetite and diet, and reduced physical activity.
The ensuing decline in physical function is a major cause of frailty, disability and death.
Treatments that can reverse or reduce the age-associated loss of muscle mass are therefore much needed.
Evidence is emerging that consumption of fish or fish oil derived long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) may be important for maintenance of muscle mass and physical function throughout the life-span.
However, the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and overall physical function is not known.
The goal of this study therefore is to determine the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and physical function in older adults.
Studietype
Intervensjonell
Registrering (Faktiske)
77
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Missouri
-
Saint Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Non-obese (i.e., BMI less than 35 kg/m2)
- Between 18 to 45 or between 60 and 85 y old
- Subjects who are sedentary (<1 h of exercise/week)
Exclusion Criteria:
- Subjects with evidence of significant organ system dysfunction (e.g. diabetes, severe cardiovascular disease, hyperlipidemia, cirrhosis, hypogonadism, uncontrolled hypo- or hyperthyroidism; uncontrolled hypertension)
- Subjects with metal implants
- Subjects with iron storage disease,
- Subjects with severe ambulatory impairments,
- Individuals with cancer or cancer that has been in remission for <5 years,
- Individuals with dementia,
- Individuals who smoke,
- Subjects who are taking medications known to affect muscle (e.g., steroids),
- Subjects who receive anticoagulant therapy.
- Subjects taking medications to control certain medical conditions (e.g., hypertension) will be included if the drug regimen has been stable for at least 6 months before entering the study and is not expected to change during the study.
- Subjects with allergies to sea food,
- Subjects who regularly consume fish oil or consume >2 servings of fish with a high LCn-3PUFA content (e.g. salmon, mackerel, sardines, etc) per week.
- Physical performance test score less than 17 out of 36.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Maisolje
|
4 grams per day for 24 weeks
|
|
Eksperimentell: Long chain omega-3 fatty acids
|
4 grams per day for 24 weeks
Andre navn:
|
|
Ingen inngripen: Young healthy controls
Young subjects' muscle mass and physical function will be evaluated once (i.e., during baseline testing only).
The data in young subjects will be used to determine the magnitude of the aging-induced decline in muscle mass and physical function in the older subjects prior to starting the interventions.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the effect of omega-3 fatty acids on muscle mass
Tidsramme: Change from baseline in muscle mass at 24 weeks in older adults only
|
We will measure thigh muscle volume by using magnetic resonance imaging.
These measurements will also be assessed at week 12 in a subset of subjects but the data will not be used as a primary outcome measure.
|
Change from baseline in muscle mass at 24 weeks in older adults only
|
|
Evaluate the effect of omega-3 fatty acids on physical function
Tidsramme: Change from baseline in physical function at 24 weeks in older adults only
|
We will evaluate muscle strength by assessing one-repetition maximum strength of upper- and lower-body skeletal muscles, grip strength and isometric and isokinetic force development.
We will assess overall physical function using the physical performance tests, which evaluates the ability to perform usual daily activities such as climbing a flight of stairs, walking 50 feet and putting on and removing a coat.
These measurements will also be assessed at week 12 in a subset of subjects but the data will not be used as a primary outcome measure.
|
Change from baseline in physical function at 24 weeks in older adults only
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the effect of aging on muscle mass
Tidsramme: During baseline testing in both young and older subjects
|
We will measure total fat-free mass by duel X-ray absorptiometry, thigh muscle and intermuscular fat volumes by using magnetic resonance imaging.
|
During baseline testing in both young and older subjects
|
|
Evaluate the effect of aging on physical function
Tidsramme: During baseline testing in both young and older subjects
|
We will evaluate muscle strength by assessing one-repetition maximum strength of upper- and lower-body skeletal muscles, grip strength, thigh isometric and isokinetic force development and time-to-peak force development during thigh isokinetic exercises.
We will assess overall physical function using the physical performance tests, which evaluates the ability to perform usual daily activities such as climbing a flight of stairs, walking 50 feet and putting on and removing a coat.
|
During baseline testing in both young and older subjects
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2011
Primær fullføring (Faktiske)
1. desember 2014
Studiet fullført (Faktiske)
1. desember 2014
Datoer for studieregistrering
Først innsendt
25. februar 2011
Først innsendt som oppfylte QC-kriteriene
2. mars 2011
Først lagt ut (Anslag)
4. mars 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201012999
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .