Nutrition, HealthyP-ProbsNCT06933589
Effect of a New Optimized Plant Ingredient on the Plant Protein of Seniors at Cardio-metabolic Risk
A study testing Test meal with plant protein and Test meal with milk protein in people with Nutrition, Healthy and Metabolic Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of the study is to compare the use of amino acids in whole-body protein metabolism in elderly consumers at risk of metabolic syndrome, after ingestion of 2 foods differing only in the nature of their proteins (optimized blend of vegetable proteins versus milk proteins). Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Metabolic Syndrome
- What is being tested?
- Test meal with plant protein and Test meal with milk protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2025to 31 May 2026
- 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 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Waist circumference > 94cm
- Triglycerides > 1.5 g/L or HDL cholesterol < 0.4 g/L
- Fasting blood glucose < 1.26g/L
- Biological profile considered compatible with study participation,
- Venous status judged satisfactory by the nurses, allowing catheter placement for the study,
- Individuals able to sign the informed consent form,
- Persons subject to a social security scheme.
Who cannot join
- Subjects on special diets (vegetarian, vegan, etc.),
- Subject showing a weight loss ≥ 5% in 1 month or ≥ 10% in 6 months compared to usual weight.
- Subject refusing to stop taking dietary supplements for the duration of the study,
- Subject refusing to consume any of the proposed products,
- Subject with food allergy(ies) to one or more components of the products under study, or with a contraindication to the consumption of these products,
- Subjects with a pathology or treatment (antidiabetics, hypolipidemics, corticoids, neuroleptics) judged by the investigator to be incompatible with the study,
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- Subjects with dysthyroidism that has not been stabilized for at least 3 months,
- Subject with unstabilized hypertension for at least 3 months,
- Subject with a medical and/or surgical history deemed by the investigator to be incompatible with the trial,
- Subject having undergone surgery that could interfere with the study objectives (as judged by the investigating physician) in the 3 months preceding the study,
- Smoking > 5 cigarettes/day,
- Alcohol > 3 glasses/day,
- Claustrophobic subject,
- Person refusing to be registered with the French Ministry of Health's Fichier National des Volontaires Sains,
- Major under guardianship or with limited rights,
- Subject not affiliated to social security,
- Subject in a period of exclusion from a previous study or having received a total amount of compensation exceeding 6000 euros over the 12 months preceding the start of the trial (after verification in the Fichier des Volontaires pour la Recherche Biomédicale).
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Yves BOIRIE
About this study
Official title: Effect of a New Optimized Plant Ingredient on the Plant Protein of Seniors at Cardio-metabolic Risk - P-Probs Project
The aim of the study is to compare the use of amino acids in whole-body protein metabolism in elderly consumers at risk of metabolic syndrome, after ingestion of 2 foods differing only in the nature of their proteins (optimized blend of vegetable proteins versus milk proteins).
The protocol consists in studying the postprandial evolution of protein metabolism. Two products will be tested: one based on dairy proteins, the other on an optimized blend of vegetable proteins).
Read the detailed description
Written consent will be obtained from subjects after they have been informed of the aims, nature and possible risks of the study.
Prior to inclusion, subjects will have a medical check-up carried out in the Nutritional Exploration Unit (UEN), including an interview about personal and family history and medication taken, as well as a standard medical examination and a blood test for a biological work-up (9.5 ml). Compliance with inclusion/exclusion criteria will be verified during this examination.
Subjects included in the study will come to the UEN to undergo the pre-study dietary visit and to complete the two study days of 9.5 hours each, at least two weeks apart.
For each study day, volunteers will arrive in the morning with an empty stomach. Two vascular catheters will be implanted. One catheter will provide continuous intravenous infusion of a labelled amino acid (13C Leucine) for a total duration of 9.5 hours. The second catheter will be used for blood sampling (8 ml), performed on an empty stomach and then, kinetically after ingestion of one of the two study products, in the form of food prepared on site. The IV-infused tracers will be used to monitor the kinetics of leucine appearance in plasma, and to quantify amino acid utilization flows at whole-body level (protein synthesis, degradation). Blood samples will also be taken to determine aminoacidemia, glycemia, insulinemia and plasma concentrations of hormones involved in regulating food intake (grelin, cholecystokinin, Glucagon-like-peptide-1 (GLP1), peptide YY (PYY).
Exhaled gases will be collected during the study days. Indirect calorimetry measurements lasting 20 minutes will be taken in the post-absorptive and post-prandial periods. Seven indirect calorimetry measurements will be taken on each study day. Finally, subjects will be asked to rate their satiety on a visual analog scale, at different times during the study days.
Subjects will also be asked to complete a tolerance questionnaire on each study day.
At the end of each study day, volunteers will have a snack at the study center before their departure. Any intercurrent events will be recorded in the observation notebook.
Allocation of the product sequence to subjects will be carried out by a random draw (generation of a random list) before the start of the study.
The volume of blood drawn per volunteer is 128 ml/study day, to which must be added 9.5 ml for the biological screening test, i.e. 265.5 ml for the entire study.
During the 3 days preceding each study day, the subjects' protein intake will be monitored. Standard menus were proposed, providing 1.2 g protein/kg/d. The meal on the evening before each study day will be standardized and identical for each day. To check compliance with the dietary instructions, volunteers will complete a dietary record for the 3 days preceding each study day.
- Conditions
- Nutrition, Healthy, Metabolic Syndrome
- Being tested
- Test meal with plant protein, Test meal with milk protein
- Keywords
- Protein
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meal with plant proteinOther
The plant protein blend is made up of 5 protein ingredients for which the food grade is guaranteed: a rice protein isolate, a potato protein isolate, a lupin protein isolate, a corn protein isolate.
Test meal with milk proteinOther
The milk protein product is a food-grade protein isolate.
| Study group | Role | What they receive |
|---|---|---|
| Plant proteins | Experimental | Test meal incorporating an optimized plant protein ingredient Receives: Other: Test meal with plant protein |
| Milk protein | Active comparator | Test meal incorporating milk proteins Receives: Other: Test meal with milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body protein metabolism
Body leucine flux kinetics: oxidation, protein synthesis
Measured: 8 months (including mass spectrometry analysis and calculations)
Secondary outcomes (3)
Satiety effect
Satiety-enhancing effect of proteins, assessed using a visual analog scale
Measured: 12 months
Evolution of blood parameters related to satiety
Plasma concentrations of glucose, insulin, ghrelin, cholecystokinin, glucagon-like-peptide (GLP1), peptide YY (PYY) and amino acids
Measured: 12 months
Product tolerance
Product tolerance assessed by questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start14 May 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each subject is asked to test 2 different products during 2 kinetics of 9.5 hours each. Each kinetic is separated by a wash-out period of at least 2 weeks.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
- Investigators
- Yves BOIRIE, Principal investigator, University Hospital, Clermont-FerrandDidier REMOND, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933589
- Sponsor's protocol ID
- RBHP 2023 RICHARD
- Other IDs
- 2023-A00959-36
- Acronym
- P-Probs
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a New Optimized Plant Ingredient on the Plant Protein of Seniors at Cardio-metabolic Risk - P-Probs Project
- ClinicalTrials.gov ID
- NCT06933589
- Acronym / sponsor ID
- P-Probs / RBHP 2023 RICHARD
- Conditions
- Nutrition, Healthy, Metabolic Syndrome
- Keywords
- Protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- 14 May 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- 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.
The aim of the study is to compare the use of amino acids in whole-body protein metabolism in elderly consumers at risk of metabolic syndrome, after ingestion of 2 foods differing only in the nature of their proteins (optimized blend of vegetable proteins versus milk proteins).
The protocol consists in studying the postprandial evolution of protein metabolism. Two products will be tested: one based on dairy proteins, the other on an optimized blend of vegetable proteins).
Detailed description
Written consent will be obtained from subjects after they have been informed of the aims, nature and possible risks of the study.
Prior to inclusion, subjects will have a medical check-up carried out in the Nutritional Exploration Unit (UEN), including an interview about personal and family history and medication taken, as well as a standard medical examination and a blood test for a biological work-up (9.5 ml). Compliance with inclusion/exclusion criteria will be verified during this examination.
Subjects included in the study will come to the UEN to undergo the pre-study dietary visit and to complete the two study days of 9.5 hours each, at least two weeks apart.
For each study day, volunteers will arrive in the morning with an empty stomach. Two vascular catheters will be implanted. One catheter will provide continuous intravenous infusion of a labelled amino acid (13C Leucine) for a total duration of 9.5 hours. The second catheter will be used for blood sampling (8 ml), performed on an empty stomach and then, kinetically after ingestion of one of the two study products, in the form of food prepared on site. The IV-infused tracers will be used to monitor the kinetics of leucine appearance in plasma, and to quantify amino acid utilization flows at whole-body level (protein synthesis, degradation). Blood samples will also be taken to determine aminoacidemia, glycemia, insulinemia and plasma concentrations of hormones involved in regulating food intake (grelin, cholecystokinin, Glucagon-like-peptide-1 (GLP1), peptide YY (PYY).
Exhaled gases will be collected during the study days. Indirect calorimetry measurements lasting 20 minutes will be taken in the post-absorptive and post-prandial periods. Seven indirect calorimetry measurements will be taken on each study day. Finally, subjects will be asked to rate their satiety on a visual analog scale, at different times during the study days.
Subjects will also be asked to complete a tolerance questionnaire on each study day.
At the end of each study day, volunteers will have a snack at the study center before their departure. Any intercurrent events will be recorded in the observation notebook.
Allocation of the product sequence to subjects will be carried out by a random draw (generation of a random list) before the start of the study.
The volume of blood drawn per volunteer is 128 ml/study day, to which must be added 9.5 ml for the biological screening test, i.e. 265.5 ml for the entire study.
During the 3 days preceding each study day, the subjects' protein intake will be monitored. Standard menus were proposed, providing 1.2 g protein/kg/d. The meal on the evening before each study day will be standardized and identical for each day. To check compliance with the dietary instructions, volunteers will complete a dietary record for the 3 days preceding each study day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Each subject is asked to test 2 different products during 2 kinetics of 9.5 hours each. Each kinetic is separated by a wash-out period of at least 2 weeks.
| Arm | Type | Receives |
|---|---|---|
| Plant proteins | Experimental | Other: Test meal with plant proteinTest meal incorporating an optimized plant protein ingredient |
| Milk protein | Active comparator | Other: Test meal with milk proteinTest meal incorporating milk proteins |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Waist circumference > 94cm
- Triglycerides > 1.5 g/L or HDL cholesterol < 0.4 g/L
- Fasting blood glucose < 1.26g/L
- Biological profile considered compatible with study participation,
- Venous status judged satisfactory by the nurses, allowing catheter placement for the study,
Key exclusion criteria (17 listed)
- Subjects on special diets (vegetarian, vegan, etc.),
- Subject showing a weight loss ≥ 5% in 1 month or ≥ 10% in 6 months compared to usual weight.
- Subject refusing to stop taking dietary supplements for the duration of the study,
- Subject refusing to consume any of the proposed products,
- Subject with food allergy(ies) to one or more components of the products under study, or with a contraindication to the consumption of these products,
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 meal with plant proteinThe plant protein blend is made up of 5 protein ingredients for which the food grade is guaranteed: a rice protein isolate, a potato protein isolate, a lupin protein isolate, a corn protein isolate. | Other | Plant proteins |
| Test meal with milk proteinThe milk protein product is a food-grade protein isolate. | Other | Milk protein |
Primary outcome
Whole body protein metabolism
Time frame: 8 months (including mass spectrometry analysis and calculations)
Body leucine flux kinetics: oxidation, protein synthesis
3 secondary outcomes
Satiety effect
Time frame: 12 months
Evolution of blood parameters related to satiety
Time frame: 12 months
Product tolerance
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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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 principal investigator
University Hospital, Clermont-Ferrand
Didier REMOND study director
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 Test meal with plant protein and Test meal with milk protein in people with Nutrition, Healthy and Metabolic Syndrome, run by University Hospital, Clermont-Ferrand 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 7 inclusion and 17 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 18 Apr 2025. 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 Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body protein metabolism (time frame: 8 months (including mass spectrometry analysis and calculations)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.