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.
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.
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 group | Role | What they receive |
|---|---|---|
| 30 g of wheat protein | Experimental | Subjects will consume 30 g of wheat protein protein type and amount Receives: 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 Receives: 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 Receives: Dietary Supplement: protein type and amount |
| 30 g of casein | Active comparator | Subjects will consume 30 g of casein protein type and amount Receives: 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 Receives: Dietary Supplement: protein type and amount |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted30 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Gorissen, Maastricht University Medical Center
- Investigators
- Luc JC van Loon, Prof. Dr., Principal investigator, Maastricht University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Muscle Protein Synthesis Following Wheat Protein Ingestion in Vivo in Humans
- ClinicalTrials.gov ID
- NCT01952639
- Acronym / sponsor ID
- METC 13-3-045
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 30 g of wheat protein | Experimental | Dietary Supplement: protein type and amountSubjects will consume 30 g of wheat protein protein type and amount |
| 30 g of wheat protein hydrolysate | Experimental | Dietary Supplement: protein type and amountSubjects will consume 30 g of wheat protein hydrolysate protein type and amount |
| 30 g of whey protein | Active comparator | Dietary Supplement: protein type and amountSubjects will consume 30 g of whey protein protein type and amount |
| 30 g of casein | Active comparator | Dietary Supplement: protein type and amountSubjects will consume 30 g of casein protein type and amount |
| 60 g of wheat protein hydrolysate | Experimental | Dietary Supplement: protein type and amountSubjects will consume 60 g of wheat protein hydrolysate protein type and amount |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Healthy males
- Age between 65 and 80 y
- BMI between 18.5 and 30 kg/m2
Key exclusion criteria (12 listed)
- Wheat allergy
- Celiac disease
- Lactose intolerance
- Smoking
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein type and amountSubjects will stay in a supine position and consume a test beverage containing different amounts ans types of protein | Dietary supplement | 30 g of casein, 30 g of wheat protein, 30 g of wheat protein hydrolysate, 30 g of whey protein, 60 g of wheat protein hydrolysate |
Primary outcome
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))
1 secondary outcome
whole-body protein metabolism
Time frame: Change in whole-body protein metabolism from baseline after ingestion of different types of protein (baseline vs. postprandial period (0-5h))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 27440260Gorissen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc JC van Loon, Prof. Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
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.