- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02406040
Effects of Short-term Energy Deficit on Muscle Protein Turnover
14. mars 2016 oppdatert av: Stuart M. Phillips, McMaster University
Weight loss through energy restriction results in the loss of both fat and muscle mass.
Muscle mass is important for mobility, strength, glucose control and energy expenditure, and therefore the retention of muscle mass during energy restriction is an important goal.
The retention of muscle mass depends on the balance between muscle protein synthesis (MPS) and muscle protein breakdown (MPB).
It is well known that MPS is reduced during weight loss, however the effect of weight loss on MPB is currently a topic of debate.
The purpose of this study is to assess the effect of short-term (10 day) weight loss (40% energy deficit) on both MPS and MPB in order to gain insight into the mechanisms causing muscle loss during energy restriction.
In addition, the effect of resistance exercise and protein (both known to preserve muscle mass) on MPS and MPB will be examined
Studieoversikt
Detaljert beskrivelse
An undesirable consequence of energy restriction is the loss of muscle mass.
Muscle mass is determined by the the rates of two processes: muscle protein synthesis and muscle protein breakdown.
It has been consistently shown that a reduced rate of muscle protein synthesis exists during energy restriction.
However, it is currently unclear whether an increase in muscle protein breakdown also contributes to muscle mass loss.
In addition, the effect of high protein diets and resistance exercise on muscle protein turnover during energy restriction, two interventions known to preserve muscle, remains to be investigated.We aim to demonstrate that the decrease in muscle protein synthesis is the main contributor to a negative protein balance during energy restriction.
In addition, we hope to show that a higher-protein diet (2.4g/kg/d versus 1.2g/kg/d) and the addition of resistance exercise can help to maintain the muscle protein synthesis rate and thereby improve negative protein balance.The present study will be designed as a parallel group randomized controlled trial.
Subjects will be given pre-packaged diets (Copper County Foods) to consume which will put them in a relative energy deficit of 40% per day.
Based on random assignment, these subjects will either consume an adequate protein diet (1.2g/kg/d) or a high protein diet (2.4g/kg/d) for 10 consecutive days.
Participants in the adequate protein diet will consume a ratio of 50:35:15 (carbohydrates:fat:protein) while subjects within the high protein diet will consume a ratio of 50:15:35 (carbohydrates:fat:protein).
Subjects will undergo testing at baseline and following a 10 day dietary and unilateral resistance exercise intervention.
Testing will consist of muscle and blood samples.
Muscle protein synthesis and muscle protein breakdown will be measured using stable isotope tracers that are orally ingested (deuterated water) or infused into an antecubital vein (labelled phenylalanine tracers) before and after the 10 day diet.
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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
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
20 år til 30 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Between the ages of 20 and 30 years inclusive
- Have a BMI between 25 and 33 inclusive
Exclusion Criteria:
- Have a body mass index less than 25 kg/m2 or greater than 33 kg/m2.
- Vegan
- History of allergy, sensitivity, or strong dislike towards dairy protein
- Smoker or user of tobacco products
- High physical activity
- Have health problems such as: renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions for which volunteers are being treated that might put them at risk for this study.
- Taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications
- Use of an investigational drug product within the last 30 days
- Have participated in an infusion protocol in the last year
- Do not understand English or have a condition the PI believes would interfere with the ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put volunteers at undue risk
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: High Protein
2.4g protein/kg/d.
The macronutrient composition will be 50:15:35 (carbohydrates:fat:protein) during Energy Restriction
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All meals will be provided for the duration of the energy restriction intervention and the energy deficit will be calculated based on estimated energy requirements by indirect calorimetry to provide 60% of energy requirements.
In addition, one leg will be assigned to perform resistance exercise for 5 days during the 10 day energy deficit.
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Eksperimentell: Adequate Protein
1.2g protein/kg/d.
The macronutrient composition will be 50:35:15 (carbohydrates:fat:protein) during Energy Restriction
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All meals will be provided for the duration of the energy restriction intervention and the energy deficit will be calculated based on estimated energy requirements by indirect calorimetry to provide 60% of energy requirements.
In addition, one leg will be assigned to perform resistance exercise for 5 days during the 10 day energy deficit.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Muscle protein turnover
Tidsramme: Baseline and 10 days
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Change in muscle protein synthesis and muscle protein breakdown before and after the weight loss diet will be assessed.
The relationship between high protein diets (parallel groups) and exercise (unilateral resistance exercise) on muscle protein turnover will also be examined.
Muscle protein synthesis and muscle protein breakdown will be measured with stable isotope infusions of labelled phenylalanine tracers before and after the 10 day diet.
In addition, long term muscle protein synthesis will be measured with orally ingested deuterated water.
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Baseline and 10 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Molecular markers
Tidsramme: Baseline and 10 days
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Change in the the transcriptional expression of genes involved in the ubiquitin-proteasome pathway (main regulator of muscle protein breakdown) measured in muscle samples obtained at baseline and following the 10 day dietary intervention by quantitative polymerase chain reaction (qPCR).
These same samples will be analyzed by western blot for the expression of active and inactive isoforms of caspase-3, an important component of muscle protein breakdown.
Finally, immunoprecipitation and western blot will be used to examine the ubiquitination of translation initiation factors at baseline and following the 10 day intervention
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Baseline and 10 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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.
Generelle publikasjoner
- Areta JL, Burke LM, Camera DM, West DW, Crawshay S, Moore DR, Stellingwerff T, Phillips SM, Hawley JA, Coffey VG. Reduced resting skeletal muscle protein synthesis is rescued by resistance exercise and protein ingestion following short-term energy deficit. Am J Physiol Endocrinol Metab. 2014 Apr 15;306(8):E989-97. doi: 10.1152/ajpendo.00590.2013. Epub 2014 Mar 4.
- Pasiakos SM, Cao JJ, Margolis LM, Sauter ER, Whigham LD, McClung JP, Rood JC, Carbone JW, Combs GF Jr, Young AJ. Effects of high-protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial. FASEB J. 2013 Sep;27(9):3837-47. doi: 10.1096/fj.13-230227. Epub 2013 Jun 5.
- Pasiakos SM, Vislocky LM, Carbone JW, Altieri N, Konopelski K, Freake HC, Anderson JM, Ferrando AA, Wolfe RR, Rodriguez NR. Acute energy deprivation affects skeletal muscle protein synthesis and associated intracellular signaling proteins in physically active adults. J Nutr. 2010 Apr;140(4):745-51. doi: 10.3945/jn.109.118372. Epub 2010 Feb 17.
- Hector AJ, Marcotte GR, Churchward-Venne TA, Murphy CH, Breen L, von Allmen M, Baker SK, Phillips SM. Whey protein supplementation preserves postprandial myofibrillar protein synthesis during short-term energy restriction in overweight and obese adults. J Nutr. 2015 Feb;145(2):246-52. doi: 10.3945/jn.114.200832. Epub 2014 Dec 17. Erratum In: J Nutr. 2015 Jun;145(6):1373.
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 2015
Primær fullføring (Faktiske)
1. januar 2016
Studiet fullført (Faktiske)
1. januar 2016
Datoer for studieregistrering
Først innsendt
28. mars 2015
Først innsendt som oppfylte QC-kriteriene
28. mars 2015
Først lagt ut (Anslag)
1. april 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Not assigned (Charles A. Dana Foundation Brain and Immuno-Imaging Grant)
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. .
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