Postprandial Muscle Protein Synthesis Following Wheat Protein Ingestion in Vivo in Humans
2 other identifiers
interventional
60
1 country
1
Brief Summary
Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a major impact on our health care system due to increased morbidity and greater need for hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to improve dietary intake of the elderly. Both whey and casein seem to offer an anabolic advantage over soy protein for promoting muscle hypertrophy. As a consequence it is assumed that (all) plant based proteins have less potent anabolic properties when compared with animal based proteins. However, there is little theoretical background for such assumptions. Objective: To provide evidence for the efficacy of wheat protein and wheat protein hydrolysate when compared with milk proteins (i.e. whey and casein) as a dietary protein to stimulate postprandial muscle protein synthesis in vivo in healthy older humans. Study design: double-blind, placebo-controlled intervention study Study population: 60 healthy non-obese (BMI 18.5-30 kg/m2) older males (age: 65-80 y) Intervention: A protein beverage (350 mL) containing 30 g of whey, casein, wheat protein, or wheat protein hydrolysate or 60 g of wheat protein hydrolysate will be consumed (n=12 per group). Main study parameters/endpoints: Primary study parameters include muscle protein synthesis rates. Secondary study parameters include whole-body protein synthesis, breakdown, oxidation, and net balance. Hypotheses: We hypothesize that ingestion of wheat protein hydrolysate results in a greater muscle protein synthetic response when compared with the intact wheat protein due to its faster digestion and absorption. Furthermore, ingestion of wheat protein hydrolysate results in a higher muscle protein synthetic response when compared with casein, but lower when compared with whey protein. Ingestion of 60 g of wheat protein hydrolysate (amount of leucine equal to 30 g of whey protein) will result in a similar muscle protein synthetic response compared to ingestion of 30 g of whey protein.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
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
September 23, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 2, 2014
November 1, 2014
9 months
September 23, 2013
November 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
muscle protein synthesis (MPS) rates
Change in MPS from baseline after ingestion of different types of protein (baseline vs. postprandial period (0-5h))
Secondary Outcomes (1)
whole-body protein metabolism
Change in whole-body protein metabolism from baseline after ingestion of different types of protein (baseline vs. postprandial period (0-5h))
Study Arms (5)
30 g of wheat protein
EXPERIMENTALSubjects will consume 30 g of wheat protein protein type and amount
30 g of wheat protein hydrolysate
EXPERIMENTALSubjects will consume 30 g of wheat protein hydrolysate protein type and amount
30 g of whey protein
ACTIVE COMPARATORSubjects will consume 30 g of whey protein protein type and amount
30 g of casein
ACTIVE COMPARATORSubjects will consume 30 g of casein protein type and amount
60 g of wheat protein hydrolysate
EXPERIMENTALSubjects will consume 60 g of wheat protein hydrolysate protein type and amount
Interventions
Subjects will stay in a supine position and consume a test beverage containing different amounts ans types of protein
Eligibility Criteria
You may qualify if:
- Healthy males
- Age between 65 and 80 y
- BMI between 18.5 and 30 kg/m2
You may not qualify if:
- Wheat allergy
- Celiac disease
- Lactose intolerance
- Smoking
- Diabetes
- Diagnosed GI tract diseases
- Arthritic conditions
- A history of neuromuscular problems
- Any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
- Use of anticoagulants
- Participation in exercise program
- Hypertension, high blood pressure that is above 140/90 mmHg.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University
Maastricht, Limburg, 6229 ER, Netherlands
Related Publications (1)
Gorissen SH, Horstman AM, Franssen R, Crombag JJ, Langer H, Bierau J, Respondek F, van Loon LJ. Ingestion of Wheat Protein Increases In Vivo Muscle Protein Synthesis Rates in Healthy Older Men in a Randomized Trial. J Nutr. 2016 Sep;146(9):1651-9. doi: 10.3945/jn.116.231340. Epub 2016 Jul 20.
PMID: 27440260DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc JC van Loon, Prof. Dr.
Maastricht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc
Study Record Dates
First Submitted
September 23, 2013
First Posted
September 30, 2013
Study Start
January 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 2, 2014
Record last verified: 2014-11