SarcopeniaNCT02157805
Technological Processes on Quality of Meat
A study testing beef meat in people with Sarcopenia, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
This project aims to assess the impact of technological processes of meat, as cooking conditions, on amino acid bioavailability and protein metabolism. The hypothesis is that, even if meat is considered as a good provider of fast proteins and so could be useful to prevent sarcopenia in aged people, the manner it is… Read more about this study
- Who is it for?
- Ages 70 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- beef meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Jan 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 70 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male
- Age > 70
- Body mass index 21 < BMI < 28 kg/m2
- Affiliated to National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical and medical examinations
Who cannot join
- Positive serologies to HIV or HCV, or abnormal laboratory tests
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Person who doesn't eat beef or only if prepared according to religious rite
- Person wearing a removable denture or suffering of dry mouth syndrome
- Regular medication with glucocorticoids
- Intense sports activity > 7h/week
Show all 10Show fewer
- Heavy alcohol consumption
- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file
- Being in exclusion on the National Volunteers Data file
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine
Clermont-Ferrand, Auvergne, 63000
About this study
Official title: Effect of Technological Processes on Nutritional Quality of Meat Proteins
This project aims to assess the impact of technological processes of meat, as cooking conditions, on amino acid bioavailability and protein metabolism. The hypothesis is that, even if meat is considered as a good provider of fast proteins and so could be useful to prevent sarcopenia in aged people, the manner it is cooked can change its digestion rate and amino acids bioavailability for muscle synthesis.
Read the detailed description
Beef meat, whose proteins were intrinsically labelled with 15 N, was previously obtained by infusing 15N ammonium sulphate during 50 days in the rumen of an heifer. Two different cooking conditions have been applied to this meat (5 min at 55°C vs 30 min at 90°C). Ten healthy elderly volunteers will test each processed meat according to a cross-over design, during 2 different metabolic studies separated by at least 2 weeks. Volunteers will be submitted to a diet controlled for its protein content, for 4 days (1.2 g protein/kg/day) before each metabolic investigation.
On the 2 days of metabolic investigations, after an overnight fast, blood samples will be collected for basal measurements. Then the subjects will be perfused with L-[1-13C] leucine for 9h30 hours, during which expired gas and blood samples will be regularly taken, and CO2 production measured. The volunteers will be asked to eat a 130 g beef meat 2.5h after the onset of the perfusion. Isotopic enrichments in expired gas, in plasma alpha-cetoiscaproate and in free leucine will be measured to determine whole body amino acids fluxes (oxidation, protein synthesis and proteolysis). 15N enrichments of leucine will allow splanchnic extraction measurement.
- Conditions
- Sarcopenia
- Being tested
- beef meat
- Keywords
- Meat processes, Amino acids bioavailability, Digestion rate, Protein synthesis, Aging, Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beef meatOther
Meat cooking conditions
- st condition : beef meat cooked during 5 minutes at 55°C
- nd condition : beef meat cooked during 30 minutes à 90°C
| Study group | Role | What they receive |
|---|---|---|
| rare beef meat | Active comparator | beef meat cooked during 5 minutes at 55°C Receives: Other: beef meat |
| well cook beef meat | Active comparator | beef meat cooked during 30 minutes à 90°C Receives: Other: beef meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acids concentrations before and during 7 hours after eating labelled meat.
Plasma amino acids concentrations before and during 7 hours after eating labelled meat.
Splanchnic extraction of leucine. Isotopic enrichments in expired gas, in plasma alpha-cetoisocaproate and in free leucine to determine whole body protein metabolism
Measured: up to 7 hours
Secondary outcomes (1)
Changes in plasma peptidome after ingestion of a meat meal
Measured: up to 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startAug 2013
- Primary completionSep 2013
- Study completionJan 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.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Principal investigator, Yves Boirie, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Yves Boirie, Md-PhD, Principal investigator, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157805
- Sponsor's protocol ID
- AU1024
- Other IDs
- 2013-A00020-45
- Status last verified
- Jun 2014
- First submitted
- 14 Jan 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Buffiere C, Gaudichon C, Hafnaoui N, Migne C, Scislowsky V, Khodorova N, Mosoni L, Blot A, Boirie Y, Dardevet D, Sante-Lhoutellier V, Remond D. In the elderly, meat protein assimilation from rare meat is lower than that from meat that is well done. Am J Clin Nutr. 2017 Nov;106(5):1257-1266. doi: 10.3945/ajcn.117.158113. Epub 2017 Sep 13.
PubMed 28903955
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Technological Processes on Nutritional Quality of Meat Proteins
- ClinicalTrials.gov ID
- NCT02157805
- Acronym / sponsor ID
- AU1024
- Conditions
- Sarcopenia
- Keywords
- Meat processes, Amino acids bioavailability, Digestion rate, Protein synthesis, Aging, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Jun 2014 (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.
This project aims to assess the impact of technological processes of meat, as cooking conditions, on amino acid bioavailability and protein metabolism. The hypothesis is that, even if meat is considered as a good provider of fast proteins and so could be useful to prevent sarcopenia in aged people, the manner it is cooked can change its digestion rate and amino acids bioavailability for muscle synthesis.
Detailed description
Beef meat, whose proteins were intrinsically labelled with 15 N, was previously obtained by infusing 15N ammonium sulphate during 50 days in the rumen of an heifer. Two different cooking conditions have been applied to this meat (5 min at 55°C vs 30 min at 90°C). Ten healthy elderly volunteers will test each processed meat according to a cross-over design, during 2 different metabolic studies separated by at least 2 weeks. Volunteers will be submitted to a diet controlled for its protein content, for 4 days (1.2 g protein/kg/day) before each metabolic investigation.
On the 2 days of metabolic investigations, after an overnight fast, blood samples will be collected for basal measurements. Then the subjects will be perfused with L-[1-13C] leucine for 9h30 hours, during which expired gas and blood samples will be regularly taken, and CO2 production measured. The volunteers will be asked to eat a 130 g beef meat 2.5h after the onset of the perfusion. Isotopic enrichments in expired gas, in plasma alpha-cetoiscaproate and in free leucine will be measured to determine whole body amino acids fluxes (oxidation, protein synthesis and proteolysis). 15N enrichments of leucine will allow splanchnic extraction measurement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rare beef meat | Active comparator | Other: beef meatbeef meat cooked during 5 minutes at 55°C |
| well cook beef meat | Active comparator | Other: beef meatbeef meat cooked during 30 minutes à 90°C |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Male
- Age > 70
- Body mass index 21 < BMI < 28 kg/m2
- Affiliated to National Health Insurance
- Subject giving his written informed consent
Key exclusion criteria (10 listed)
- Positive serologies to HIV or HCV, or abnormal laboratory tests
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Person who doesn't eat beef or only if prepared according to religious rite
- Person wearing a removable denture or suffering of dry mouth syndrome
- Regular medication with glucocorticoids
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 |
|---|---|---|
| beef meatMeat cooking conditions 1. st condition : beef meat cooked during 5 minutes at 55°C 2. nd condition : beef meat cooked during 30 minutes à 90°C | Other | rare beef meat, well cook beef meat |
Primary outcome
Plasma amino acids concentrations before and during 7 hours after eating labelled meat.
Time frame: up to 7 hours
Plasma amino acids concentrations before and during 7 hours after eating labelled meat. Splanchnic extraction of leucine. Isotopic enrichments in expired gas, in plasma alpha-cetoisocaproate and in free leucine to determine whole body protein metabolism
1 secondary outcome
Changes in plasma peptidome after ingestion of a meat meal
Time frame: up to 7 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 6 Jun 2014.
- Derived from this study: PubMed 28903955Buffiere C, Gaudichon C, Hafnaoui N, Migne C, Scislowsky V, Khodorova N, Mosoni L, Blot A, Boirie Y, Dardevet D, Sante-Lhoutellier V, Remond D. In the elderly, meat protein assimilation from rare meat is lower than that from meat that is well done. Am J Clin Nutr. 2017 Nov;106(5):1257-1266. doi: 10.3945/ajcn.117.158113. Epub 2017 Sep 13.
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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.
Yves Boirie, Md-PhD principal investigator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beef meat in people with Sarcopenia, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
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 6 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 6 Jun 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 France. 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?
Plasma amino acids concentrations before and during 7 hours after eating labelled meat. (time frame: up to 7 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 NCT02157805, 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 6 Jun 2014.