NCT03313830

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

October 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

3.1 years

First QC Date

October 6, 2017

Last Update Submit

November 6, 2020

Conditions

Keywords

WheyMuscle Protein Synthesis

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)

EXPERIMENTAL

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)

Intact Whey Protein (WHEY)

EXPERIMENTAL

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)

Interventions

Subjects will ingest WPH on one occasion.

Whey Protein Hydrolysate (WPH)
Intact Whey Protein (WHEY)DIETARY_SUPPLEMENT

Subject will ingest WHEY on another occasion.

Intact Whey Protein (WHEY)

Eligibility Criteria

Age20 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

UTMB

Galveston, Texas, 77555, United States

Location

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.

Study Officials

  • Blake Rasmussen, PhD

    UTMB

    PRINCIPAL INVESTIGATOR

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

Locations