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AzTrials

SarcopeniaNCT01952639

Postprandial Muscle Protein Synthesis Following Wheat Protein Ingestion in Vivo in Humans

A study testing protein type and amount in people with Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years, men onlyHealthy volunteers can take part
Conditions the study is for
Sarcopenia
What is being tested?
protein type and amount
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteNetherlands
Study dates
Jan 2014to Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • Men only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Healthy males
  • Age between 65 and 80 y
  • BMI between 18.5 and 30 kg/m2

Who cannot join

  • Wheat allergy
  • Celiac disease
  • Lactose intolerance
  • Smoking
  • Diabetes
  • Diagnosed GI tract diseases
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Maastricht University

    Maastricht, Limburg, 6229 ER

Other trials in Netherlands

About this study

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.

Read more

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.

Read the detailed description

Aging is accompanied by a progressive decline in skeletal muscle mass. This age-related loss of muscle mass, or sarcopenia, is attributed to an imbalance between muscle protein synthesis and breakdown. As basal muscle protein synthesis rates do not seem to differ between young and elderly, most research has focused on potential impairments in the muscle protein synthetic response to the main anabolic stimuli, i.e. food intake and exercise. Skeletal muscle protein synthesis is highly responsive to food intake in healthy young adults. Recent data indicate that the muscle protein synthetic response to food intake may be blunted in the elderly. This proposed anabolic resistance is now being regarded as a key factor in the etiology of sarcopenia. Effective strategies to prevent and/or counteract the age-related loss of muscle mass include protein supplementation, preferably in combination with resistance exercise. Recent studies show the efficacy of dietary protein supplementation to improve muscle strength and function in frail elderly and to further augment the gains in muscle mass and function when combined with resistance exercise. As a consequence, nutrition research is now looking for the optimal amount, type, and timing of protein consumption to maximize postprandial muscle protein synthesis rates.

Improvements in protein balance and/or higher muscle protein synthesis rates have been reported following the ingestion of various types of dietary protein: whey, casein, soy, casein hydrolysate, egg protein, and whole-milk and/or fat-free milk. It seems obvious to question which source of dietary protein is most effective in promoting muscle protein synthesis. There is only limited research comparing the efficacy of the ingestion of different proteins sources on the protein synthetic response. As such, it is difficult to identify a specific protein source that is most potentiating. This is further complicated by the fact that numerous parameters modulate the muscle protein synthetic response to protein ingestion. The amount and timing of protein administration, the amino acid composition of the protein, and the digestion and absorption kinetics of the protein source (or mixed meal), may all modulate the muscle protein synthetic response.

Milk proteins, i.e. whey and casein, are the most widely studied dietary proteins. Casein and whey seem to have distinct anabolic properties, which are attributed to differences in digestion and absorption kinetics. Whey protein is a soluble protein that leads to fast intestinal absorption, whereas intact casein clots in the stomach delaying its digestion and absorption and the subsequent release of amino acids in the circulation. The faster, but more transient rise in plasma amino acid concentration after whey protein ingestion can lead to higher protein synthesis rates. In addition to intrinsic differences in digestion and absorption rate, it has been suggested that whey protein can more effectively stimulate protein synthesis due to its greater leucine content when compared to casein. 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. In this study we will assess the capacity of wheat protein ingestion as a means to increase postprandial muscle protein synthesis in vivo in humans. By directly comparing the anabolic properties of wheat protein or wheat protein hydrolysate with both casein and whey, we will determine the anabolic properties of wheat protein (hydrolysate) in vivo in older humans.

Conditions
Sarcopenia
Being tested
protein type and amount
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • protein type and amountDietary supplement

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

Study groups in NCT01952639
Study groupRoleWhat they receive
30 g of wheat proteinExperimentalSubjects will consume 30 g of wheat protein protein type and amount
Receives: Dietary Supplement: protein type and amount
30 g of wheat protein hydrolysateExperimentalSubjects will consume 30 g of wheat protein hydrolysate protein type and amount
Receives: Dietary Supplement: protein type and amount
30 g of whey proteinActive comparatorSubjects will consume 30 g of whey protein protein type and amount
Receives: Dietary Supplement: protein type and amount
30 g of caseinActive comparatorSubjects will consume 30 g of casein protein type and amount
Receives: Dietary Supplement: protein type and amount
60 g of wheat protein hydrolysateExperimentalSubjects will consume 60 g of wheat protein hydrolysate protein type and amount
Receives: Dietary Supplement: protein type and amount

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. muscle protein synthesis (MPS) rates

    Measured: Change in MPS from baseline after ingestion of different types of protein (baseline vs. postprandial period (0-5h))

Secondary outcomes (1)
  1. whole-body protein metabolism

    Whole-body protein metabolism consists of protein breakdown, synthesis, oxidation, and net balance. This will assessed by measuring plasma enrichments of the infused and ingested tracers and calculate the endogenous rate of appearance (breakdown), total rate of disappearance (synthesis), oxidation, and net protein balance (synthesis - breakdown).

    Measured: Change in whole-body protein metabolism from baseline after ingestion of different types of protein (baseline vs. postprandial period (0-5h))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01952639
Sponsor's protocol ID
METC 13-3-045
Other IDs
NL45958.068.13
Status last verified
Nov 2014
First submitted
23 Sep 2013
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27440260

Questions about this trial

What is this clinical trial studying?

A study testing protein type and amount in people with Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

muscle protein synthesis (MPS) rates (time frame: Change in MPS from baseline after ingestion of different types of protein (baseline vs. postprandial period (0-5h))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01952639, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

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