- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02406040
Effects of Short-term Energy Deficit on Muscle Protein Turnover
14. března 2016 aktualizováno: 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
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
24
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ontario
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Hamilton, Ontario, Kanada, L8S 4K1
- Exercise Metabolism Research Laboratory, McMaster Univeristy
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let až 30 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Mužský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Muscle protein turnover
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Molecular markers
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. června 2015
Primární dokončení (Aktuální)
1. ledna 2016
Dokončení studie (Aktuální)
1. ledna 2016
Termíny zápisu do studia
První předloženo
28. března 2015
První předloženo, které splnilo kritéria kontroly kvality
28. března 2015
První zveřejněno (Odhad)
1. dubna 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
16. března 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. března 2016
Naposledy ověřeno
1. března 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Not assigned (Charles A. Dana Foundation Brain and Immuno-Imaging Grant)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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