HealthyLEG'UPNCT06624033
Bioavailability of Legume Proteins in Differents Products
A study testing amino acids kinetics in people with Healthy and Men, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
The use of pea proteins could be interesting in specific foods. Indeed, these proteins could have great nutritional quality, with good amino acid profile. Therefore, the investigators study the bioavailability of protein and post-prandial variation of metabolic markers following consumption of pea protein-enriched… Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- What is being tested?
- amino acids kinetics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2020to 22 Sep 2023
- 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 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Major male volunteers under 30 (<30)
- Body mass index between 22 and 28 kg/m²
- Subjects considered healthy by investigator based on the examination, medical and clinical examination,
- biological check up considered compatible with study participation
- person who is in the position to sign informed consent
Who cannot join
- Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
- Subject weight < 60 kg
- Subject refusing to consume one of the proposed products or the test meal
- Subject with a food allergy(s) to one or more components of the study products (gluten, legumes, etc.), or with a contribution to the consumption of these products.
- Subject with tumor pathology, inflammatory, moderate to severe kidney failure, malabsorption syndrome,
- Subject being under drug treatment or dietary supplement that may influence the results of kinetics: treatments that may affect gastric emptying, intestinal absorption (smectite-based intestinal dressings, etc.), insulin and blood sugar, Oral nutritional supplements (NOC), proton pump inhibitors (PPIs), corticosteroids, nonsteroidal anti-inflammatory drugs, antibiotics for less than a month,
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- Subject with diabetes or dyslipidemia,
- Subject with a heavy medical or surgical history that may pose a risk to the volunteer under the protocol,
- Subject who has undergone surgery that may interfere with the objectives of the study (at the discretion of the investigating physician) within 3 months preceding the study,
- Person refusing to be registered on the National File of Healthy Volunteers of the Ministry of Health,
- Major subject under trusteeship or with limited rights,
- Subject not affiliated with social security,
- Subject during the exclusion period of a previous study (after verification in the Biomedical Research Volunteers File).
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Clinique d'Auvergne
Clermont-Ferrand, Auvergne, 63009
About this study
Official title: Single-blind, Randomized, Cross-over Comparative Bioavailability Study About the Kinetics of Plasma Amino Acid Concentrations Subsequent to the Consumption of Innovative Legume-based Products.
The use of pea proteins could be interesting in specific foods. Indeed, these proteins could have great nutritional quality, with good amino acid profile. Therefore, the investigators study the bioavailability of protein and post-prandial variation of metabolic markers following consumption of pea protein-enriched products in healthy young subjects.
Main Objective is to compare plasma kinetics of leucine.
Read the detailed description
The written agreement of the subjects will be obtained after information on the aims, nature and possible risks of the study.
Before inclusion, the volunteers will be subjected to a medical check-up at the Nutritional Exploration Unit which includes an examination of personal and family history and current drug treatments, as well as a standard medical examination and a blood test for a biological check-up. Compliance with the inclusion/ exclusion criteria will be verified during this review.
Volunteers included in the protocol will go to the Clinical Pharmacology Center (CPC) to perform the tests. At each visit, each volunteer will receive one of the six products.
The volunteer will be reviewed six times for the realization of a kinetics. First, three visits will be made with at least 7 days apart (wash out period). Then, after a 15-day break, three others visits will be organized spaced at least 7 days apart. The day before each visit, the evening meal will be standardized and eaten before 9 pm. A short catheter will be placed in a vein in the forearm for blood samples. After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion.
On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. Any intercurrent events will be noted in the observation book. The test meal sequence will be randomly assigned to subjects (generating a random list) prior to the start of the study.
- Being tested
- amino acids kinetics
- Keywords
- amino acid, legume, pea, protein
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acids kineticsOther
After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion.
On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Chocolate cake with peas | Experimental | the subjects will consume the test meals (arm title) Receives: Other: amino acids kinetics |
| Biscuit with peas | Experimental | the subjects will consume the test meals (arm title). Receives: Other: amino acids kinetics |
| chopped steack with peas | Experimental | the subjects will consume the test meals (arm title). Receives: Other: amino acids kinetics |
| Chocolate cake with gluten | Placebo comparator | the subjects will consume the test meals (arm title) Receives: Other: amino acids kinetics |
| biscuit with gluten | Placebo comparator | the subjects will consume the test meals (arm title). Receives: Other: amino acids kinetics |
| chopped steack | Placebo comparator | the subjects will consume the test meals (arm title). Receives: Other: amino acids kinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal)
Measured: 0 minute before the consumption of the test meals
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.
Measured: 15 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.
Measured: 30 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.
Measured: 60 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.
Measured: 90 minutes after ingestion meals
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.
Measured: 120 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.
Measured: 150 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.
Measured: 180 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.
Measured: 210 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.
Measured: 240 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.
Measured: 270 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).One point at 300 minutes after the consumption of one of the 6 test periods.
Measured: 300 minutes after ingestion
Changes in the plasma concentrations of leucinemia
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.
Measured: 360 minutes after ingestion
Secondary outcomes (73)
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.
Measured: 0 minute before the consumption of the test meals,
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.
Measured: 15 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.
Measured: 30 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 45 minutes after the consumption of one of the 6 test periods.
Measured: 45 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.
Measured: 60 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.
Measured: 90 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.
Measured: 120 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.
Measured: 180 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.
Measured: 210 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.
Measured: 240 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.
Measured: 270 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 300 minutes after the consumption of one of the 6 test periods.
Measured: 300 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.
Measured: 360 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.
Measured: 0 minute before the consumption of the test meals
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.
Measured: 15 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.
Measured: 30 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 45 minutes after the consumption of one of the 6 test periods.
Measured: 45 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.
Measured: 60 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.
Measured: 90 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.
Measured: 120 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.
Measured: 150 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.
Measured: 180 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.
Measured: 210 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.
Measured: 240 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.
Measured: 270 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 300 minutes after the consumption of one of the 6 test periods.
Measured: 300 minutes after ingestion
Changes of Blood sugar levels
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.
Measured: 360 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.
Measured: 0 minute before the consumption of the test meals
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.
Measured: 15 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.
Measured: 30 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 45 minutes after the consumption of one of the 6 test periods.
Measured: 45 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.
Measured: 60 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.
Measured: 90 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.
Measured: 120 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.
Measured: 150 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.
Measured: 180 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.
Measured: 210 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.
Measured: 240 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.
Measured: 270 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 300 minutes after the consumption of one of the 6 test periods.
Measured: 300 minutes after ingestion
Changes of insulin levels
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.
Measured: 360 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.
Measured: 0 minute before the consumption of the test meals
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.
Measured: 15 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.
Measured: 30 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 45 minutes after the consumption of one of the 6 test periods.
Measured: 45 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.
Measured: 60 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.
Measured: 90 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.
Measured: 120 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.
Measured: 150 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.
Measured: 180 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.
Measured: 210 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.
Measured: 240 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.
Measured: 270 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 300 minutes after the consumption of one of the 6 test periods.
Measured: 300 minutes after ingestion
Changes lipid profile
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.
Measured: 360 minutes after ingestion
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal) the consumption of one of the 6 test periods.
Measured: 0 minute before the consumption of the test meals
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.
Measured: 15 minutes after ingestion
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.
Measured: 30 minutes after ingestion
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.
Measured: 60 minutes after ingestion
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.
Measured: 90 minutes after ingestion
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.
Measured: 120 minutes after ingestion
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.
Measured: 150 minutes after ingestion
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.
Measured: 240 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 0 minute before the consumption of the test meals
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 15 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 30 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 60 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 90 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 120 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 180 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 240 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 300 minutes after ingestion
Areas under curves
maximum concentration and time to reach this concentration will be compared between test meals
Measured: 360 minutes after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start22 Jun 2020
- Primary completion22 Sep 2022
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- participants may receive 6 products in 6 interventions sequentially during the protocol
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 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, Adeline BLOT, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Marine Gueugneau, Phd, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624033
- Sponsor's protocol ID
- CRNH 1 -2020
- Acronym
- LEG'UP
- Status last verified
- Sep 2024
- First submitted
- 9 Nov 2020
- Last updated
- 2 Oct 2024
- 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Randomized, Cross-over Comparative Bioavailability Study About the Kinetics of Plasma Amino Acid Concentrations Subsequent to the Consumption of Innovative Legume-based Products.
- ClinicalTrials.gov ID
- NCT06624033
- Acronym / sponsor ID
- LEG'UP / CRNH 1 -2020
- Keywords
- amino acid, legume, pea, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 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
- 22 Jun 2020 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 2 Oct 2024 (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 use of pea proteins could be interesting in specific foods. Indeed, these proteins could have great nutritional quality, with good amino acid profile. Therefore, the investigators study the bioavailability of protein and post-prandial variation of metabolic markers following consumption of pea protein-enriched products in healthy young subjects.
Main Objective is to compare plasma kinetics of leucine.
Detailed description
The written agreement of the subjects will be obtained after information on the aims, nature and possible risks of the study.
Before inclusion, the volunteers will be subjected to a medical check-up at the Nutritional Exploration Unit which includes an examination of personal and family history and current drug treatments, as well as a standard medical examination and a blood test for a biological check-up. Compliance with the inclusion/ exclusion criteria will be verified during this review.
Volunteers included in the protocol will go to the Clinical Pharmacology Center (CPC) to perform the tests. At each visit, each volunteer will receive one of the six products.
The volunteer will be reviewed six times for the realization of a kinetics. First, three visits will be made with at least 7 days apart (wash out period). Then, after a 15-day break, three others visits will be organized spaced at least 7 days apart. The day before each visit, the evening meal will be standardized and eaten before 9 pm. A short catheter will be placed in a vein in the forearm for blood samples. After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion.
On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. Any intercurrent events will be noted in the observation book. The test meal sequence will be randomly assigned to subjects (generating a random list) prior to the start of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- participants may receive 6 products in 6 interventions sequentially during the protocol
| Arm | Type | Receives |
|---|---|---|
| Chocolate cake with peas | Experimental | Other: amino acids kineticsthe subjects will consume the test meals (arm title) |
| Biscuit with peas | Experimental | Other: amino acids kineticsthe subjects will consume the test meals (arm title). |
| chopped steack with peas | Experimental | Other: amino acids kineticsthe subjects will consume the test meals (arm title). |
| Chocolate cake with gluten | Placebo comparator | Other: amino acids kineticsthe subjects will consume the test meals (arm title) |
| biscuit with gluten | Placebo comparator | Other: amino acids kineticsthe subjects will consume the test meals (arm title). |
| chopped steack | Placebo comparator | Other: amino acids kineticsthe subjects will consume the test meals (arm title). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Major male volunteers under 30 (<30)
- Body mass index between 22 and 28 kg/m²
- Subjects considered healthy by investigator based on the examination, medical and clinical examination,
- biological check up considered compatible with study participation
- person who is in the position to sign informed consent
Key exclusion criteria (13 listed)
- Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
- Subject weight < 60 kg
- Subject refusing to consume one of the proposed products or the test meal
- Subject with a food allergy(s) to one or more components of the study products (gluten, legumes, etc.), or with a contribution to the consumption of these products.
- Subject with tumor pathology, inflammatory, moderate to severe kidney failure, malabsorption syndrome,
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 |
|---|---|---|
| amino acids kineticsAfter a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion. On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. | Other | Biscuit with peas, Chocolate cake with gluten, Chocolate cake with peas, biscuit with gluten, chopped steack, chopped steack with peas |
Primary outcome
Changes in the plasma concentrations of leucinemia
Time frame: 0 minute before the consumption of the test meals
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point before (basal)
Changes in the plasma concentrations of leucinemia
Time frame: 15 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 15 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 30 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 30 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 60 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 60 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 90 minutes after ingestion meals
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 90 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 120 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 120 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 150 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 150 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 180 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 180 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 210 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 210 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 240 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 240 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 270 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 270 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 300 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).One point at 300 minutes after the consumption of one of the 6 test periods.
Changes in the plasma concentrations of leucinemia
Time frame: 360 minutes after ingestion
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product). One point at 360 minutes after the consumption of one of the 6 test periods.
73 secondary outcomes
Changes in the plasma concentrations of the others amino acids
Time frame: 0 minute before the consumption of the test meals,
Changes in the plasma concentrations of the others amino acids
Time frame: 15 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 30 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 45 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 60 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 90 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 120 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 180 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 210 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 240 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 270 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 300 minutes after ingestion
Changes in the plasma concentrations of the others amino acids
Time frame: 360 minutes after ingestion
Changes of Blood sugar levels
Time frame: 0 minute before the consumption of the test meals
Changes of Blood sugar levels
Time frame: 15 minutes after ingestion
Changes of Blood sugar levels
Time frame: 30 minutes after ingestion
Changes of Blood sugar levels
Time frame: 45 minutes after ingestion
Changes of Blood sugar levels
Time frame: 60 minutes after ingestion
Changes of Blood sugar levels
Time frame: 90 minutes after ingestion
Changes of Blood sugar levels
Time frame: 120 minutes after ingestion
Changes of Blood sugar levels
Time frame: 150 minutes after ingestion
Changes of Blood sugar levels
Time frame: 180 minutes after ingestion
Changes of Blood sugar levels
Time frame: 210 minutes after ingestion
Changes of Blood sugar levels
Time frame: 240 minutes after ingestion
Changes of Blood sugar levels
Time frame: 270 minutes after ingestion
Changes of Blood sugar levels
Time frame: 300 minutes after ingestion
Changes of Blood sugar levels
Time frame: 360 minutes after ingestion
Changes of insulin levels
Time frame: 0 minute before the consumption of the test meals
Changes of insulin levels
Time frame: 15 minutes after ingestion
Changes of insulin levels
Time frame: 30 minutes after ingestion
Changes of insulin levels
Time frame: 45 minutes after ingestion
Changes of insulin levels
Time frame: 60 minutes after ingestion
Changes of insulin levels
Time frame: 90 minutes after ingestion
Changes of insulin levels
Time frame: 120 minutes after ingestion
Changes of insulin levels
Time frame: 150 minutes after ingestion
Changes of insulin levels
Time frame: 180 minutes after ingestion
Changes of insulin levels
Time frame: 210 minutes after ingestion
Changes of insulin levels
Time frame: 240 minutes after ingestion
Changes of insulin levels
Time frame: 270 minutes after ingestion
Changes of insulin levels
Time frame: 300 minutes after ingestion
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 2 Oct 2024.
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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.
Marine Gueugneau, Phd 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 amino acids kinetics in people with Healthy and Men, 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 5 inclusion and 13 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 2 Oct 2024. 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. Some participants in this study may receive a placebo. 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?
Changes in the plasma concentrations of leucinemia (time frame: 0 minute before the consumption of the test meals). The study lists 13 primary outcomes in all. 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 2 Oct 2024.