We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Effect of Whey Protein Hydrolysate on Human Muscle Protein Synthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03313830
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : November 10, 2020
Meiji Co., Ltd.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Whey Protein Hydrolysate (WPH) Dietary Supplement: Intact Whey Protein (WHEY) Not Applicable

Detailed Description:

The central hypothesis will be tested in 10 healthy young adults (20-35 yr). The subjects will be studied in the post-absorptive state on two different days, during which they will randomly assigned to drink a WPH or WHEY mixture.

Measures of muscle protein synthesis will be taken at baseline, one and three hours following nutrient ingestion.

The expected outcome of the proposed work is the identification of a new nutritional strategy for activating skeletal muscle protein synthesis. The findings of the proposed studies will have a positive impact, because they will allow us to translate this information into evidence-based clinical interventions to improve muscle size, strength and function and improve recovery after conditions associated with muscle wasting.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Whey Protein Hydrolysate on Human Muscle Protein Synthesis
Actual Study Start Date : October 7, 2017
Actual Primary Completion Date : November 6, 2020
Actual Study Completion Date : November 6, 2020

Arm Intervention/treatment
Experimental: Whey Protein Hydrolysate (WPH)
The intervention consists of Whey Protein Hydrolysate (WPH) ingestion by young healthy subjects to determine rates of muscle protein synthesis.
Dietary Supplement: Whey Protein Hydrolysate (WPH)
Subjects will ingest WPH on one occasion.

Experimental: Intact Whey Protein (WHEY)
The intervention consists of Intact Whey Protein (WHEY) ingestion by young healthy subjects to determine rates of muscle protein synthesis.
Dietary Supplement: Intact Whey Protein (WHEY)
Subject will ingest WHEY on another occasion.

Primary Outcome Measures :
  1. muscle protein synthesis [ Time Frame: change from Baseline muscle protein synthesis at 3 hours after mixture ingestion ]
    measure muscle protein turnover by stable isotope infusion trial

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Men age 20-35 yrs
  2. Stable body weight for at least 1 year
  3. Able to provide written consent and understand the study requirements and procedures

Exclusion Criteria:

  1. Exercise training
  2. Significant heart, liver, kidney, blood, respiratory disease or thyroid issues
  3. Peripheral vascular disease
  4. Orthopedic injury
  5. Diabetes mellitus or other untreated endocrine disease
  6. Active cancer (all groups) and history of cancer
  7. Acute infectious disease or history of chronic infections
  8. Neurologic Injury or disease
  9. Recent systemic treatment with anabolic steroids, or corticosteroids.
  10. Alcohol or drug abuse
  11. Tobacco use
  12. Malnutrition
  13. Obesity
  14. Low hemoglobin levels
  15. Food allergies
  16. Taking dietary supplements
  17. Chronic use of aspirin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313830

Layout table for location information
United States, Texas
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Meiji Co., Ltd.
Layout table for investigator information
Principal Investigator: Blake Rasmussen, PhD UTMB
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03313830    
Other Study ID Numbers: 17-0086
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Medical Branch, Galveston:
Muscle Protein Synthesis