SarcopeniaNCT00557388
Dietary Strategies to Promote Muscle Protein Anabolism in the Elderly
A study testing Protein/Amino Acids and Physical exercise in people with Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Aging is associated with the loss of lean muscle mass, termed sarcopenia. Food intake and in particular the ingestion of protein or amino acids has been shown to be a powerful stimulus to promote net muscle protein anabolism. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Protein/Amino Acids and Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2007to Nov 2010
- 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 18 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In study A, non-obese male subjects (BMI <27) between the age of 18-30 yrs and 70-85 yrs will be selected.
- In studies B and C, non-obese male subjects (BMI <27) between the age of 70-85 yrs will be selected.
Who cannot join
- Type II diabetes or other known diseases
- Use of medication
- Female
- Other ages or BMI than indicated above
- Participation in any regular exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
Aging is associated with the loss of lean muscle mass, termed sarcopenia. Food intake and in particular the ingestion of protein or amino acids has been shown to be a powerful stimulus to promote net muscle protein anabolism. However this anabolic response following a meal-like protein bolus seems to be blunted in the elderly as compared to young adults.
The first aim of this proposal is to investigate the post-prandial muscle protein synthesis rates in young and elderly men in response to a meal-like protein bolus after a period of rest or physical activity (study A). The rest trial (REST) will act as a proof-of-principle study to examine the blunted protein synthetic response in the elderly, and as a control trial in comparison with the exercise trial (EXC) to establish the surplus value of physical activity prior to protein intake on muscle protein synthesis.
Read more
The second aim of this proposal is to determine the surplus value of an increased quantity of the ingested protein bolus (study B). Large amounts of protein (40 and 60 g) will be compared to a meal-like amount of protein (20 g) as a means to maximize plasma amino acid availability and/or to stimulate muscle protein anabolism.
The third aim of this proposal is to study the differences in quality of the ingested protein bolus (study C). Instead of significantly increasing the quantity of the protein bolus, we will also apply a more practical approach to augment skeletal muscle protein synthesis rates; modifying the digestibility or amino acid composition of a meal-like protein bolus.
- Conditions
- Sarcopenia
- Being tested
- Protein/Amino Acids, Physical exercise
- Keywords
- muscle loss, aging, protein, amino acids, exercise, protein synthesis
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein/Amino AcidsDietary supplement
Casein Whey Leucine
Physical exerciseOther
The physical exercise protocol will consist of low intensity cycling and light resistance-type exercise; after 5 minutes of self-paced cycling, subjects will perform 6 sets of 10 repetitions on the horizontal leg press machine (Technogym BV, Rotterdam, The Netherlands) and 6 sets of 10 repetitions on the leg extension machine (Technogym BV, Rotterdam, The Netherlands). The first 2 sets of both resistance exercises will be performed at 40% of the subjects' 1RM. Sets 3-4, and 5-6 will be performed at 55% and 75% of 1RM, respectively, with 2 minutes rest intervals between sets.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Young men 18-30 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids; Other: Physical exercise |
| 2 | Experimental | Young men 18-30 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids |
| 3 | Experimental | Old men 70-85 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids; Other: Physical exercise |
| 4 | Experimental | Old men 70-85 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids |
| 5 | Experimental | Old men 70-85 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids |
| 6 | Experimental | Old men 70-85 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids |
| 7 | Experimental | Old men 70-85 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids |
| 8 | Experimental | Old men 70-85 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids |
| 9 | Experimental | Old men 70-85 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids |
| 10 | Experimental | Old men 70-85 years, BMI < 27 kg/m2 Receives: Dietary Supplement: Protein/Amino Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
All interventions will affect muscle protein synthesis. With the application of amino acid tracer methodology we are able to determine muscle protein synthesis.
Measured: 6 hours
Secondary outcomes (1)
Differences in rate of uptake/absorption from the intestine.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Nutrition and Food Technology Institute
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, Phd, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557388
- Sponsor's protocol ID
- MEC 07-3-086
- Other IDs
- TIFN A-1002
- Status last verified
- Sep 2011
- First submitted
- 13 Nov 2007
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 32069356Pennings B, Groen B, de Lange A, Gijsen AP, Zorenc AH, Senden JM, van Loon LJ. Amino acid absorption and subsequent muscle protein accretion following graded intakes of whey protein in elderly men. Am J Physiol Endocrinol Metab. 2012 Apr 15;302(8):E992-9. doi: 10.1152/ajpendo.00517.2011. Epub 2012 Feb 14.
PubMed 22338070Pennings B, Boirie Y, Senden JM, Gijsen AP, Kuipers H, van Loon LJ. Whey protein stimulates postprandial muscle protein accretion more effectively than do casein and casein hydrolysate in older men. Am J Clin Nutr. 2011 May;93(5):997-1005. doi: 10.3945/ajcn.110.008102. Epub 2011 Mar 2.
PubMed 21367943Pennings B, Koopman R, Beelen M, Senden JM, Saris WH, van Loon LJ. Exercising before protein intake allows for greater use of dietary protein-derived amino acids for de novo muscle protein synthesis in both young and elderly men. Am J Clin Nutr. 2011 Feb;93(2):322-31. doi: 10.3945/ajcn.2010.29649. Epub 2010 Nov 17.
PubMed 21084649
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Strategies to Promote Muscle Protein Anabolism in the Elderly
- ClinicalTrials.gov ID
- NCT00557388
- Acronym / sponsor ID
- MEC 07-3-086
- Conditions
- Sarcopenia
- Keywords
- muscle loss, aging, protein, amino acids, exercise, protein synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- National Nutrition and Food Technology Institute
- Study start
- Dec 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Nov 2007 (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.
Aging is associated with the loss of lean muscle mass, termed sarcopenia. Food intake and in particular the ingestion of protein or amino acids has been shown to be a powerful stimulus to promote net muscle protein anabolism. However this anabolic response following a meal-like protein bolus seems to be blunted in the elderly as compared to young adults.
The first aim of this proposal is to investigate the post-prandial muscle protein synthesis rates in young and elderly men in response to a meal-like protein bolus after a period of rest or physical activity (study A). The rest trial (REST) will act as a proof-of-principle study to examine the blunted protein synthetic response in the elderly, and as a control trial in comparison with the exercise trial (EXC) to establish the surplus value of physical activity prior to protein intake on muscle protein synthesis.
The second aim of this proposal is to determine the surplus value of an increased quantity of the ingested protein bolus (study B). Large amounts of protein (40 and 60 g) will be compared to a meal-like amount of protein (20 g) as a means to maximize plasma amino acid availability and/or to stimulate muscle protein anabolism.
The third aim of this proposal is to study the differences in quality of the ingested protein bolus (study C). Instead of significantly increasing the quantity of the protein bolus, we will also apply a more practical approach to augment skeletal muscle protein synthesis rates; modifying the digestibility or amino acid composition of a meal-like protein bolus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Protein/Amino Acids, Other: Physical exerciseYoung men 18-30 years, BMI < 27 kg/m2 |
| 2 | Experimental | Dietary Supplement: Protein/Amino AcidsYoung men 18-30 years, BMI < 27 kg/m2 |
| 3 | Experimental | Dietary Supplement: Protein/Amino Acids, Other: Physical exerciseOld men 70-85 years, BMI < 27 kg/m2 |
| 4 | Experimental | Dietary Supplement: Protein/Amino AcidsOld men 70-85 years, BMI < 27 kg/m2 |
| 5 | Experimental | Dietary Supplement: Protein/Amino AcidsOld men 70-85 years, BMI < 27 kg/m2 |
| 6 | Experimental | Dietary Supplement: Protein/Amino AcidsOld men 70-85 years, BMI < 27 kg/m2 |
| 7 | Experimental | Dietary Supplement: Protein/Amino AcidsOld men 70-85 years, BMI < 27 kg/m2 |
| 8 | Experimental | Dietary Supplement: Protein/Amino AcidsOld men 70-85 years, BMI < 27 kg/m2 |
| 9 | Experimental | Dietary Supplement: Protein/Amino AcidsOld men 70-85 years, BMI < 27 kg/m2 |
| 10 | Experimental | Dietary Supplement: Protein/Amino AcidsOld men 70-85 years, BMI < 27 kg/m2 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In study A, non-obese male subjects (BMI <27) between the age of 18-30 yrs and 70-85 yrs will be selected.
- In studies B and C, non-obese male subjects (BMI <27) between the age of 70-85 yrs will be selected.
Key exclusion criteria (5 listed)
- Type II diabetes or other known diseases
- Use of medication
- Female
- Other ages or BMI than indicated above
- Participation in any regular exercise program.
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/Amino AcidsCasein Whey Leucine | Dietary supplement | 1, 10, 2, 3, 4, 5, 6, 7, 8, 9 |
| Physical exerciseThe physical exercise protocol will consist of low intensity cycling and light resistance-type exercise; after 5 minutes of self-paced cycling, subjects will perform 6 sets of 10 repetitions on the horizontal leg press machine (Technogym BV, Rotterdam, The Netherlands) and 6 sets of 10 repetitions on the leg extension machine (Technogym BV, Rotterdam, The Netherlands). The first 2 sets of both resistance exercises will be performed at 40% of the subjects' 1RM. Sets 3-4, and 5-6 will be performed at 55% and 75% of 1RM, respectively, with 2 minutes rest intervals between sets. | Other | 1, 3 |
Primary outcome
All interventions will affect muscle protein synthesis. With the application of amino acid tracer methodology we are able to determine muscle protein synthesis.
Time frame: 6 hours
1 secondary outcome
Differences in rate of uptake/absorption from the intestine.
Time frame: 6 hours
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 14 Sep 2011.
- 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 22338070Pennings B, Groen B, de Lange A, Gijsen AP, Zorenc AH, Senden JM, van Loon LJ. Amino acid absorption and subsequent muscle protein accretion following graded intakes of whey protein in elderly men. Am J Physiol Endocrinol Metab. 2012 Apr 15;302(8):E992-9. doi: 10.1152/ajpendo.00517.2011. Epub 2012 Feb 14.
- Derived from this study: PubMed 21367943Pennings B, Boirie Y, Senden JM, Gijsen AP, Kuipers H, van Loon LJ. Whey protein stimulates postprandial muscle protein accretion more effectively than do casein and casein hydrolysate in older men. Am J Clin Nutr. 2011 May;93(5):997-1005. doi: 10.3945/ajcn.110.008102. Epub 2011 Mar 2.
- Derived from this study: PubMed 21084649Pennings B, Koopman R, Beelen M, Senden JM, Saris WH, van Loon LJ. Exercising before protein intake allows for greater use of dietary protein-derived amino acids for de novo muscle protein synthesis in both young and elderly men. Am J Clin Nutr. 2011 Feb;93(2):322-31. doi: 10.3945/ajcn.2010.29649. Epub 2010 Nov 17.
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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 van Loon, Phd 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/Amino Acids and Physical exercise 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 2 inclusion and 5 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 14 Sep 2011. 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?
All interventions will affect muscle protein synthesis. With the application of amino acid tracer methodology we are able to determine muscle protein synthesis. (time frame: 6 hours). 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 NCT00557388, which also lists 4 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 14 Sep 2011.