NCT01952639

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

September 23, 2013

Last Update Submit

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

EXPERIMENTAL

Subjects will consume 30 g of wheat protein protein type and amount

Dietary Supplement: protein type and amount

30 g of wheat protein hydrolysate

EXPERIMENTAL

Subjects will consume 30 g of wheat protein hydrolysate protein type and amount

Dietary Supplement: protein type and amount

30 g of whey protein

ACTIVE COMPARATOR

Subjects will consume 30 g of whey protein protein type and amount

Dietary Supplement: protein type and amount

30 g of casein

ACTIVE COMPARATOR

Subjects will consume 30 g of casein protein type and amount

Dietary Supplement: protein type and amount

60 g of wheat protein hydrolysate

EXPERIMENTAL

Subjects will consume 60 g of wheat protein hydrolysate protein type and amount

Dietary Supplement: protein type and amount

Interventions

protein type and amountDIETARY_SUPPLEMENT

Subjects will stay in a supine position and consume a test beverage containing different amounts ans types of protein

30 g of casein30 g of wheat protein30 g of wheat protein hydrolysate30 g of whey protein60 g of wheat protein hydrolysate

Eligibility Criteria

Age65 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Luc JC van Loon, Prof. Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

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

Locations