SarcopeniaPro-HabNCT01986842
Habitual Protein Intake and Muscle Protein Synthesis
A study testing Protein diet in people with Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Protein intake stimulates muscle protein synthesis. From the standpoint of maintaining skeletal muscle mass with aging, it is important to optimize the adaptive response to food intake. However, a paucity of information is available describing the effects of habitual dietary protein intake (i.e. Read more about this study
- Who is it for?
- Ages 55 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Jul 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 55 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Age between 55 and 75 y
- BMI between 18.5 and 30 kg/m2
Who cannot join
- Lactose intolerance
- Smoking and alcohol abuse
- Diabetes
- Diagnosed GI tract diseases
- Arthritic conditions
- A history of neuromuscular problems
Show all 10Show fewer
- 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
Official title: The Impact of Habitual Dietary Protein Intake on the Anabolic Response in Elderly Men
Protein intake stimulates muscle protein synthesis. From the standpoint of maintaining skeletal muscle mass with aging, it is important to optimize the adaptive response to food intake. However, a paucity of information is available describing the effects of habitual dietary protein intake (i.e. either high or low amounts of dietary protein consumed on a regular basis), on the subsequent meal-induced stimulation of muscle protein synthesis. An adaptation to a diet of several days or weeks may involve splanchnic and/or skeletal muscle adaptations that may further enhance, or decrease, the amino acid sensitivity of muscle protein synthesis after protein ingestion.
The aim of this study is to investigate the effect of a habitual (14 days) high protein diet when compared with low protein diet on digestion and absorption kinetics and the subsequent muscle protein synthetic response to dietary protein ingestion.
Read the detailed description
During the adult life skeletal muscle mass remains fairly constant until the fourth or fifth decade. Then, the slow process of sarcopenia (the age-related loss of muscle mass) is believed to begin. The maintenance of skeletal muscle mass is regulated by a balance between the opposing processes of muscle protein synthesis and muscle protein breakdown. Food intake, dietary protein in particular, stimulates muscle protein synthesis and allows net muscle protein accretion throughout the day, which allows the normal maintenance of muscle mass in healthy individuals. Many studies have described the postprandial muscle protein synthetic response to protein intake and/or physical activity, and these acute findings have led to recommendations for protein intake for both athletes wishing to gain muscle mass as well as patients and elderly individuals to help them maintaining muscle mass. However, translating the acute findings from a single meal to long-term recommendations is perhaps premature, since scientists know very little with regard to how previous consumed meals affect the anabolic responsiveness to subsequent food intake. A characteristic of the adaptation to habitual high or low protein intake is thought to be associated with a change in the amplitude of diurnal cycle of whole body proteins. If this speculation is accurate, it implies that the muscle protein synthetic responses to feeding (differences between fasting and feeding muscle protein synthesis rates) are adapting to differing habitual protein intake, which may reduce (or enhance) the anabolic responsiveness to protein intake.
To gain a more complete scientific understanding, it is necessary to examine whether an adaptation does in fact occur after habitual high or low amounts of protein intake with regard to the anabolic response to subsequent protein intake. In the present investigation, we wish to investigate the impact of the habitual consumption of either high or low protein diets for 14 days on the anabolic responsiveness to a protein meal in healthy elderly. Previous work has determined that whole body adaptations to protein intake occur after >10 days. Collectively, our findings will be valuable to maximize the skeletal muscle adaptive response to food intake and, ultimately, to develop nutritional strategies for maintenance or enhancement of skeletal muscle mass in elderly men.
- Conditions
- Sarcopenia
- Being tested
- Protein diet
- Keywords
- Muscle protein synthesis, Digestion and absorption kinetics, Leucine, Whey protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein dietDietary supplement
Subjects will receive either a low protein or a high protein diet for 14 days. High protein will be realized with protein supplements.
| Study group | Role | What they receive |
|---|---|---|
| Low protein | Experimental | Subject will receive a low protein diet (0.7 g/kg BW/day) for 14 days prior to the experimental trial Receives: Dietary Supplement: Protein diet |
| High protein | Experimental | Subjects will receive a high protein diet (1.5 g/kg BW/day) for 14 days prior to the experimental trial Receives: Dietary Supplement: Protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis rates
Change in MPS rates during the postprandial phase when compared with the basal phase
Measured: 0-5 h postprandial period
Secondary outcomes (1)
Digestion/Absorption kinetics
Difference in digestion of the intrinsically labeled protein after a 14-day period of high vs. low protein diet
Measured: 0-5 h postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986842
- Sponsor's protocol ID
- METC 13-3-050
- Acronym
- Pro-Hab
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
PubMed 32069356Gorissen SH, Horstman AM, Franssen R, Kouw IW, Wall BT, Burd NA, de Groot LC, van Loon LJ. Habituation to low or high protein intake does not modulate basal or postprandial muscle protein synthesis rates: a randomized trial. Am J Clin Nutr. 2017 Feb;105(2):332-342. doi: 10.3945/ajcn.115.129924. Epub 2016 Nov 30.
PubMed 27903518
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
- The Impact of Habitual Dietary Protein Intake on the Anabolic Response in Elderly Men
- ClinicalTrials.gov ID
- NCT01986842
- Acronym / sponsor ID
- Pro-Hab / METC 13-3-050
- Conditions
- Sarcopenia
- Keywords
- Muscle protein synthesis, Digestion and absorption kinetics, Leucine, Whey protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Nov 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.
Protein intake stimulates muscle protein synthesis. From the standpoint of maintaining skeletal muscle mass with aging, it is important to optimize the adaptive response to food intake. However, a paucity of information is available describing the effects of habitual dietary protein intake (i.e. either high or low amounts of dietary protein consumed on a regular basis), on the subsequent meal-induced stimulation of muscle protein synthesis. An adaptation to a diet of several days or weeks may involve splanchnic and/or skeletal muscle adaptations that may further enhance, or decrease, the amino acid sensitivity of muscle protein synthesis after protein ingestion.
The aim of this study is to investigate the effect of a habitual (14 days) high protein diet when compared with low protein diet on digestion and absorption kinetics and the subsequent muscle protein synthetic response to dietary protein ingestion.
Detailed description
During the adult life skeletal muscle mass remains fairly constant until the fourth or fifth decade. Then, the slow process of sarcopenia (the age-related loss of muscle mass) is believed to begin. The maintenance of skeletal muscle mass is regulated by a balance between the opposing processes of muscle protein synthesis and muscle protein breakdown. Food intake, dietary protein in particular, stimulates muscle protein synthesis and allows net muscle protein accretion throughout the day, which allows the normal maintenance of muscle mass in healthy individuals. Many studies have described the postprandial muscle protein synthetic response to protein intake and/or physical activity, and these acute findings have led to recommendations for protein intake for both athletes wishing to gain muscle mass as well as patients and elderly individuals to help them maintaining muscle mass. However, translating the acute findings from a single meal to long-term recommendations is perhaps premature, since scientists know very little with regard to how previous consumed meals affect the anabolic responsiveness to subsequent food intake. A characteristic of the adaptation to habitual high or low protein intake is thought to be associated with a change in the amplitude of diurnal cycle of whole body proteins. If this speculation is accurate, it implies that the muscle protein synthetic responses to feeding (differences between fasting and feeding muscle protein synthesis rates) are adapting to differing habitual protein intake, which may reduce (or enhance) the anabolic responsiveness to protein intake.
To gain a more complete scientific understanding, it is necessary to examine whether an adaptation does in fact occur after habitual high or low amounts of protein intake with regard to the anabolic response to subsequent protein intake. In the present investigation, we wish to investigate the impact of the habitual consumption of either high or low protein diets for 14 days on the anabolic responsiveness to a protein meal in healthy elderly. Previous work has determined that whole body adaptations to protein intake occur after >10 days. Collectively, our findings will be valuable to maximize the skeletal muscle adaptive response to food intake and, ultimately, to develop nutritional strategies for maintenance or enhancement of skeletal muscle mass in elderly men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low protein | Experimental | Dietary Supplement: Protein dietSubject will receive a low protein diet (0.7 g/kg BW/day) for 14 days prior to the experimental trial |
| High protein | Experimental | Dietary Supplement: Protein dietSubjects will receive a high protein diet (1.5 g/kg BW/day) for 14 days prior to the experimental trial |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males
- Age between 55 and 75 y
- BMI between 18.5 and 30 kg/m2
Key exclusion criteria (10 listed)
- Lactose intolerance
- Smoking and alcohol abuse
- Diabetes
- Diagnosed GI tract diseases
- Arthritic conditions
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 dietSubjects will receive either a low protein or a high protein diet for 14 days. High protein will be realized with protein supplements. | Dietary supplement | High protein, Low protein |
Primary outcome
Muscle protein synthesis rates
Time frame: 0-5 h postprandial period
Change in MPS rates during the postprandial phase when compared with the basal phase
1 secondary outcome
Digestion/Absorption kinetics
Time frame: 0-5 h postprandial period
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 32069356Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
- Derived from this study: PubMed 27903518Gorissen SH, Horstman AM, Franssen R, Kouw IW, Wall BT, Burd NA, de Groot LC, van Loon LJ. Habituation to low or high protein intake does not modulate basal or postprandial muscle protein synthesis rates: a randomized trial. Am J Clin Nutr. 2017 Feb;105(2):332-342. doi: 10.3945/ajcn.115.129924. Epub 2016 Nov 30.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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, PhD principal investigator
Maastricht University Medical Center
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 diet 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 10 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 rates (time frame: 0-5 h postprandial period). 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 NCT01986842, which also lists 2 linked publications.
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.