- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01292395
Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
10. august 2017 opdateret af: United States Army Research Institute of Environmental Medicine
The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake
Military personnel face many physiological challenges, including sustained physical activity and prolonged periods of negative energy balance.
Chronic energy deficiency often results in a loss of skeletal muscle mass and can reduce overall bone health.
Recent evidence suggests that dietary interventions that provide protein in excess of the current national dietary recommendation may confer protection against the negative effects of energy deficiency on the musculoskeletal system.
The primary objective of this randomized, controlled study is to assess the effects dietary protein intake spanning the current acceptable macronutrient distribution range on musculoskeletal health following prolonged energy deficiency.
Findings from this investigation will improve current understanding of dietary conditions necessary to reduce the damaging effects of caloric deficiency on musculoskeletal health in warfighters.
Furthermore, given the rise in obesity in military populations, findings may aid in the development of nutritional weight management strategies that promote healthy weight loss without compromising musculoskeletal health.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
42
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
North Dakota
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Grand Forks, North Dakota, Forenede Stater, 58202
- USDA Grand Forks Human Nutrition Research Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 42 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Weight stable with body mass index 22-29 kg/m2
- Physically active
- Refrain from NSAIDS and other aspirin containing medications
- Refrain from alcohol and nicotine
Exclusion Criteria:
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders
- Disease or medication that affects metabolism and/or exercise
- Allergies or intolerance to foods, vegetarian practices, or medications to be used in the study
- Anemia and Sickle Cell Anemia/Trait; abnormal PT/PTT test or problems with blood clotting
- Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
- Musculoskeletal injuries that compromise the ability to exercise
- Blood donation within 8 weeks of beginning the study
- Pregnancy and women not on contraceptives
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Protein level 1
|
Protein intakes within the current recommendation
|
|
Eksperimentel: Protein level 2
|
Protein intakes within the current recommendation
|
|
Eksperimentel: Protein level 3
|
Protein intakes within the current recommendation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from weight maintenance in muscle metabolism after energy restriction
Tidsramme: Measured after a 3 week energy deficit
|
Measured after a 3 week energy deficit
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from weight maintenance in bone metabolism after energy restriction
Tidsramme: Measured after a 3 week energy deficit
|
Measured after a 3 week energy deficit
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Stefan M Pasiakos, PhD, United States Army Research Institute of Environmental Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Carbone JW, McClung JP, Pasiakos SM. Skeletal muscle responses to negative energy balance: effects of dietary protein. Adv Nutr. 2012 Mar 1;3(2):119-26. doi: 10.3945/an.111.001792.
- Cao JJ, Pasiakos SM, Margolis LM, Sauter ER, Whigham LD, McClung JP, Young AJ, Combs GF Jr. Calcium homeostasis and bone metabolic responses to high-protein diets during energy deficit in healthy young adults: a randomized controlled trial. Am J Clin Nutr. 2014 Feb;99(2):400-7. doi: 10.3945/ajcn.113.073809. Epub 2013 Nov 27.
- Pasiakos SM, Margolis LM, McClung JP, Cao JJ, Whigham LD, Combs GF, Young AJ. Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial. Int J Obes (Lond). 2014 Jul;38(7):1015-8. doi: 10.1038/ijo.2013.197. Epub 2013 Oct 29.
- Carbone JW, Margolis LM, McClung JP, Cao JJ, Murphy NE, Sauter ER, Combs GF Jr, Young AJ, Pasiakos SM. Effects of energy deficit, dietary protein, and feeding on intracellular regulators of skeletal muscle proteolysis. FASEB J. 2013 Dec;27(12):5104-11. doi: 10.1096/fj.13-239228. Epub 2013 Aug 21.
- 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.
- Karl JP, Thompson LA, Niro PJ, Margolis LM, McClung JP, Cao JJ, Whigham LD, Combs GF Jr, Young AJ, Lieberman HR, Pasiakos SM. Transient decrements in mood during energy deficit are independent of dietary protein-to-carbohydrate ratio. Physiol Behav. 2015 Feb;139:524-31. doi: 10.1016/j.physbeh.2014.11.068. Epub 2014 Dec 3.
- Henning PC, Margolis LM, McClung JP, Young AJ, Pasiakos SM. High protein diets do not attenuate decrements in testosterone and IGF-I during energy deficit. Metabolism. 2014 May;63(5):628-32. doi: 10.1016/j.metabol.2014.02.007. Epub 2014 Feb 17.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2010
Primær færdiggørelse (Faktiske)
1. november 2011
Studieafslutning (Faktiske)
1. november 2011
Datoer for studieregistrering
Først indsendt
19. januar 2011
Først indsendt, der opfyldte QC-kriterier
7. februar 2011
Først opslået (Skøn)
9. februar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H10-03
- 503 (Anden identifikator: USDA GFHNRC)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .