Effect of Whey Protein Hydrolysate on Human Muscle Protein Synthesis
1 other identifier
interventional
11
1 country
1
Brief Summary
Muscle protein synthesis can be stimulated by ingestion of protein sources, such as whey, casein or soy. Protein supplementation can be useful to restore protein turnover after exercise but also to preserve skeletal muscle mass and function in aging adults. Ingestion of large doses of essential amino acids (EAA) or certain protein supplements may be an effective strategy to induce muscle protein synthesis. However, in many cases, it may not be practical or feasible to consume a large volume of amino acids or protein required for an effective response by muscle. Several evidences show how reduced strength and muscle mass, even in early life, are predictors of early mortality which explicit the importance of developing more effective methods to improve muscle quality. Therefore, identifying the better sources of protein that have higher anabolic potency is of high significance. The goal of this study is to determine the anabolic potency and efficacy of a new and novel Whey Protein Hydrolysate mixture (WPH) on skeletal muscle protein synthesis in healthy young subjects (age 20-35 yr). Previous studies on rats indicate WPH induces significant increases in muscle protein synthesis compared with carbohydrates or whey-amino acid mixture. WPH contains mostly peptides, which have physiological effects and could be absorbed more rapidly. Preliminary data from preclinical study has also demonstrated that WPH can stimulate muscle protein synthesis at lower doses compared with intact whey proteins. Thus, WPH could be absorbed more rapidly and may maximally stimulate muscle protein synthesis. Although there is substantial data on the individual effects of BCCA and intact protein such as whey, there have been no clinical investigations that have explored the efficacy of WPH for stimulating muscle protein synthesis in humans. Therefore, the investigators propose that WPH will increase muscle protein synthesis. They will compare the response of WHP to the response of WHEY when equal protein is provided in both treatments. 10 healthy subjects will be recruited and will receive both WPH and WHEY supplementation in a single blind crossover design. Muscle protein synthesis will be measured on both occasions. This acute study will allow to determine whether low dose WPH supplementation will be an effective nutritional treatment to stimulate muscle protein synthesis in young adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Oct 2017
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2017
CompletedStudy Start
First participant enrolled
October 7, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2020
CompletedNovember 10, 2020
November 1, 2020
3.1 years
October 6, 2017
November 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
muscle protein synthesis
measure muscle protein turnover by stable isotope infusion trial
change from Baseline muscle protein synthesis at 3 hours after mixture ingestion
Study Arms (2)
Whey Protein Hydrolysate (WPH)
EXPERIMENTALThe intervention consists of Whey Protein Hydrolysate (WPH) ingestion by young healthy subjects to determine rates of muscle protein synthesis.
Intact Whey Protein (WHEY)
EXPERIMENTALThe intervention consists of Intact Whey Protein (WHEY) ingestion by young healthy subjects to determine rates of muscle protein synthesis.
Interventions
Subjects will ingest WPH on one occasion.
Subject will ingest WHEY on another occasion.
Eligibility Criteria
You may qualify if:
- Men age 20-35 yrs
- Stable body weight for at least 1 year
- Able to provide written consent and understand the study requirements and procedures
You may not qualify if:
- Exercise training
- Significant heart, liver, kidney, blood, respiratory disease or thyroid issues
- Peripheral vascular disease
- Orthopedic injury
- Diabetes mellitus or other untreated endocrine disease
- Active cancer (all groups) and history of cancer
- Acute infectious disease or history of chronic infections
- Neurologic Injury or disease
- Recent systemic treatment with anabolic steroids, or corticosteroids.
- Alcohol or drug abuse
- Tobacco use
- Malnutrition
- Obesity
- Low hemoglobin levels
- Food allergies
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Medical Branch, Galvestonlead
- Meiji Co., Ltd.collaborator
Study Sites (1)
UTMB
Galveston, Texas, 77555, United States
Related Publications (1)
Moro T, Brightwell CR, Velarde B, Fry CS, Nakayama K, Sanbongi C, Volpi E, Rasmussen BB. Whey Protein Hydrolysate Increases Amino Acid Uptake, mTORC1 Signaling, and Protein Synthesis in Skeletal Muscle of Healthy Young Men in a Randomized Crossover Trial. J Nutr. 2019 Jul 1;149(7):1149-1158. doi: 10.1093/jn/nxz053.
PMID: 31095313DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Blake Rasmussen, PhD
UTMB
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2017
First Posted
October 18, 2017
Study Start
October 7, 2017
Primary Completion
November 6, 2020
Study Completion
November 6, 2020
Last Updated
November 10, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share