PhysiologyNCT01685307
Impact of Cooking Process on Meat Protein Digestion and Metabolism
A study testing Test meal in people with Physiology and Digestive Tract, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
Few is known on meat protein digestibility in humans and the impact of cooking process, while excessive intake of processed meat has been suggested to increase the risk of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiology, Digestive Tract, Heating Process
- What is being tested?
- Test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Sep 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- BMI between 18 an 27
- Age between 18 and 45 years
Who cannot join
- Gastrointestinal or liver pathology
- Diabetes
- Pregnancy
- Vegetarian
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Recherche sur volontaires
Bobigny, 93
Gheorghe Airinei, 33 1 48 95 53 34, gheorghe.airinei@avc.aphp.fr
Robert Benamouzig, MD, PhD
About this study
Few is known on meat protein digestibility in humans and the impact of cooking process, while excessive intake of processed meat has been suggested to increase the risk of colorectal cancer.
This study aims to measure in vivo in humans the real digestibility of beef meat proteins depending 2 cooking processes, using ileal tubes and stable isotopes.
- Conditions
- Physiology, Digestive Tract, Heating Process
- Being tested
- Test meal
- Keywords
- ileal digestibility, metabolism, stable isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test mealDietary supplement
test meal is 150 g of beef cooked either at moderate or high intensity. Proteins are intrinsically labelled with 15N.
| Study group | Role | What they receive |
|---|---|---|
| intense cooking process | Experimental | Test meal: 150g of beef cooked at intense temperature. Beef proteins are intrinsically labelled with 15 N protein Receives: Dietary Supplement: Test meal |
| mild cooking process | Experimental | Test meal: 150 g of beef cooked at moderate intensity. Beef proteins are intrinsically labeled with 15N. Receives: Dietary Supplement: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
protein digestibility
From ileal recovery of the ingested tracer during 8 h after the meal
Measured: single measure
Secondary outcomes (1)
nitrogen metabolism
Distribution of dietary nitrogen throug metabolic pools
Measured: single measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
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 PhysiologyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Principal investigator, Robert Benamouzig, Assistance Publique - Hôpitaux de Paris
- Investigators
- Claire Gaudichon, PhD, Study director, INRA AgroParisTech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685307
- Sponsor's protocol ID
- PRONUTRIAL
- Status last verified
- Sep 2012
- First submitted
- 21 Mar 2012
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oberli M, Marsset-Baglieri A, Airinei G, Sante-Lhoutellier V, Khodorova N, Remond D, Foucault-Simonin A, Piedcoq J, Tome D, Fromentin G, Benamouzig R, Gaudichon C. High True Ileal Digestibility but Not Postprandial Utilization of Nitrogen from Bovine Meat Protein in Humans Is Moderately Decreased by High-Temperature, Long-Duration Cooking. J Nutr. 2015 Oct;145(10):2221-8. doi: 10.3945/jn.115.216838. Epub 2015 Aug 19.
PubMed 26290008
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cooking Process on Meat Protein Digestion and Metabolism
- ClinicalTrials.gov ID
- NCT01685307
- Acronym / sponsor ID
- PRONUTRIAL
- Conditions
- Physiology, Digestive Tract, Heating Process
- Keywords
- ileal digestibility, metabolism, stable isotopes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- First posted
- 14 Sep 2012 (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.
Few is known on meat protein digestibility in humans and the impact of cooking process, while excessive intake of processed meat has been suggested to increase the risk of colorectal cancer.
This study aims to measure in vivo in humans the real digestibility of beef meat proteins depending 2 cooking processes, using ileal tubes and stable isotopes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intense cooking process | Experimental | Dietary Supplement: Test mealTest meal: 150g of beef cooked at intense temperature. Beef proteins are intrinsically labelled with 15 N protein |
| mild cooking process | Experimental | Dietary Supplement: Test mealTest meal: 150 g of beef cooked at moderate intensity. Beef proteins are intrinsically labeled with 15N. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- BMI between 18 an 27
- Age between 18 and 45 years
Key exclusion criteria (4 listed)
- Gastrointestinal or liver pathology
- Diabetes
- Pregnancy
- Vegetarian
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 |
|---|---|---|
| Test mealtest meal is 150 g of beef cooked either at moderate or high intensity. Proteins are intrinsically labelled with 15N. | Dietary supplement | intense cooking process, mild cooking process |
Primary outcome
protein digestibility
Time frame: single measure
From ileal recovery of the ingested tracer during 8 h after the meal
1 secondary outcome
nitrogen metabolism
Time frame: single measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Derived from this study: PubMed 26290008Oberli M, Marsset-Baglieri A, Airinei G, Sante-Lhoutellier V, Khodorova N, Remond D, Foucault-Simonin A, Piedcoq J, Tome D, Fromentin G, Benamouzig R, Gaudichon C. High True Ileal Digestibility but Not Postprandial Utilization of Nitrogen from Bovine Meat Protein in Humans Is Moderately Decreased by High-Temperature, Long-Duration Cooking. J Nutr. 2015 Oct;145(10):2221-8. doi: 10.3945/jn.115.216838. Epub 2015 Aug 19.
Related trials for Physiology
RecruitingEarly Phase 1
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Normal Physiology
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Claire Gaudichon, PhD study director
INRA AgroParisTech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal in people with Physiology and Digestive Tract, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Sep 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gheorghe Airinei, MD (33 1 48 95 74 30, gheorghe.airinei@avc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
protein digestibility (time frame: single measure). 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 NCT01685307, 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 14 Sep 2012.