AgingNCT01145131
Dietary Interventions for Muscle Mass
A study testing Intact or minced beef meat in people with Aging, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether meat structure plays an important role in protein digestion, to maximise the amino acid availability and to stimulate the muscle protein growth in elderly people. Read more about this study
- Who is it for?
- Ages 65 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Intact or minced beef meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to Jun 2011
- 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 85 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Non-obese male subjects (BMI<30) between the age of 65-85 years.
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.
Netherlands1 site
Universiteit Maastricht, Bewegingswetenschappen
Maastricht, Limburg, 6229ER
About this study
Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether meat structure plays an important role in protein digestion, to maximise the amino acid availability and to stimulate the muscle protein growth in elderly people.
- Conditions
- Aging
- Being tested
- Intact or minced beef meat
- Keywords
- muscle, FSR, protein, meat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact or minced beef meatOther
Also called Beef steak, Minced beef, Beef patty, Steak
135 gram piece of intact or minced beef meat, beef steak or minced beef resp.
| Study group | Role | What they receive |
|---|---|---|
| Beef steak | Experimental | Not described Receives: Other: Intact or minced beef meat |
| Minced beef | Experimental | Not described Receives: Other: Intact or minced beef meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound D5phe tracer, by the enrichment of the precursor (=plasma availability).
Measured: 6 h postprandial period
Secondary outcomes (1)
Dietary amino acid plasma availability
The exogenous rate of phenylalanine appearance will be used to assess the bio-availability of dietary-protein derived amino acids in the circulation during the 6h postprandial period following meat intake
Measured: 6h postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- B Pennings, Ir, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145131
- Sponsor's protocol ID
- MEC 10-3-065
- Status last verified
- Sep 2011
- First submitted
- 15 Jun 2010
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Mioche L, Bourdiol P, Monier S, Martin JF, Cormier D. Changes in jaw muscles activity with age: effects on food bolus properties. Physiol Behav. 2004 Sep 30;82(4):621-7. doi: 10.1016/j.physbeh.2004.05.012.
PubMed 15327909Mioche L, Bourdiol P, Monier S. Chewing behaviour and bolus formation during mastication of meat with different textures. Arch Oral Biol. 2003 Mar;48(3):193-200. doi: 10.1016/s0003-9969(03)00002-5.
PubMed 12648556Pennings B, Groen BB, van Dijk JW, de Lange A, Kiskini A, Kuklinski M, Senden JM, van Loon LJ. Minced beef is more rapidly digested and absorbed than beef steak, resulting in greater postprandial protein retention in older men. Am J Clin Nutr. 2013 Jul;98(1):121-8. doi: 10.3945/ajcn.112.051201. Epub 2013 May 1.
PubMed 23636241
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 Interventions for Muscle Mass
- ClinicalTrials.gov ID
- NCT01145131
- Acronym / sponsor ID
- MEC 10-3-065
- Conditions
- Aging
- Keywords
- muscle, FSR, protein, meat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Jun 2010 (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.
Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether meat structure plays an important role in protein digestion, to maximise the amino acid availability and to stimulate the muscle protein growth in elderly people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beef steak | Experimental | Other: Intact or minced beef meat |
| Minced beef | Experimental | Other: Intact or minced beef meat |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Non-obese male subjects (BMI<30) between the age of 65-85 years.
Key exclusion criteria (1 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 |
|---|---|---|
| Intact or minced beef meatAlso: Beef steak, Minced beef, Beef patty, Steak135 gram piece of intact or minced beef meat, beef steak or minced beef resp. | Other | Beef steak, Minced beef |
Primary outcome
Muscle protein synthesis
Time frame: 6 h postprandial period
Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound D5phe tracer, by the enrichment of the precursor (=plasma availability).
1 secondary outcome
Dietary amino acid plasma availability
Time frame: 6h 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 14 Sep 2011.
- Results publication: PubMed 15327909Mioche L, Bourdiol P, Monier S, Martin JF, Cormier D. Changes in jaw muscles activity with age: effects on food bolus properties. Physiol Behav. 2004 Sep 30;82(4):621-7. doi: 10.1016/j.physbeh.2004.05.012.
- Results publication: PubMed 12648556Mioche L, Bourdiol P, Monier S. Chewing behaviour and bolus formation during mastication of meat with different textures. Arch Oral Biol. 2003 Mar;48(3):193-200. doi: 10.1016/s0003-9969(03)00002-5.
- Derived from this study: PubMed 23636241Pennings B, Groen BB, van Dijk JW, de Lange A, Kiskini A, Kuklinski M, Senden JM, van Loon LJ. Minced beef is more rapidly digested and absorbed than beef steak, resulting in greater postprandial protein retention in older men. Am J Clin Nutr. 2013 Jul;98(1):121-8. doi: 10.3945/ajcn.112.051201. Epub 2013 May 1.
- Information about research performed by the Maastricht Muscle Metabolism group at MUMCLink provided by the sponsor.
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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.
B Pennings, Ir 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 Intact or minced beef meat in people with Aging, 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 1 inclusion and 1 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?
Muscle protein synthesis (time frame: 6 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 NCT01145131, which also lists 3 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.