Clinical trial NCT06624033: Bioavailability of Legume Proteins in Differents Products
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Men
Keywords: amino acid
legume
pea
protein
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Nutrition Humaine d'Auvergne
First posted: 2024-10-02
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: participants may receive 6 products in 6 interventions sequentially during the protocol
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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,
* 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).

Primary outcomes:
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 0 minute before the consumption of the test meals
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 15 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 30 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 60 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 90 minutes after ingestion meals
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 120 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 150 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 180 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 210 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 240 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 270 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 300 minutes after ingestion
measure: Changes in the plasma concentrations of leucinemia
timeFrame: 360 minutes after ingestion
Secondary outcomes:
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 0 minute before the consumption of the test meals,
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 15 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 30 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 45 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 60 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 90 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 120 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 180 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 210 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 240 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 270 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 300 minutes after ingestion
measure: Changes in the plasma concentrations of the others amino acids
timeFrame: 360 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 0 minute before the consumption of the test meals
measure: Changes of Blood sugar levels
timeFrame: 15 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 30 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 45 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 60 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 90 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 120 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 150 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 180 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 210 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 240 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 270 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 300 minutes after ingestion
measure: Changes of Blood sugar levels
timeFrame: 360 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 0 minute before the consumption of the test meals
measure: Changes of insulin levels
timeFrame: 15 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 30 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 45 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 60 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 90 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 120 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 150 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 180 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 210 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 240 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 270 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 300 minutes after ingestion
measure: Changes of insulin levels
timeFrame: 360 minutes after ingestion
measure: Changes lipid profile
timeFrame: 0 minute before the consumption of the test meals
measure: Changes lipid profile
timeFrame: 15 minutes after ingestion
measure: Changes lipid profile
timeFrame: 30 minutes after ingestion
measure: Changes lipid profile
timeFrame: 45 minutes after ingestion
measure: Changes lipid profile
timeFrame: 60 minutes after ingestion
measure: Changes lipid profile
timeFrame: 90 minutes after ingestion
measure: Changes lipid profile
timeFrame: 120 minutes after ingestion
measure: Changes lipid profile
timeFrame: 150 minutes after ingestion
measure: Changes lipid profile
timeFrame: 180 minutes after ingestion
measure: Changes lipid profile
timeFrame: 210 minutes after ingestion
measure: Changes lipid profile
timeFrame: 240 minutes after ingestion
measure: Changes lipid profile
timeFrame: 270 minutes after ingestion
measure: Changes lipid profile
timeFrame: 300 minutes after ingestion
measure: Changes lipid profile
timeFrame: 360 minutes after ingestion
measure: Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
timeFrame: 0 minute before the consumption of the test meals
measure: Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
timeFrame: 15 minutes after ingestion
measure: Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
timeFrame: 30 minutes after ingestion
measure: Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
timeFrame: 60 minutes after ingestion
measure: Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
timeFrame: 90 minutes after ingestion
measure: Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
timeFrame: 120 minutes after ingestion
measure: Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
timeFrame: 150 minutes after ingestion
measure: Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
timeFrame: 240 minutes after ingestion
measure: Areas under curves
timeFrame: 0 minute before the consumption of the test meals
measure: Areas under curves
timeFrame: 15 minutes after ingestion
measure: Areas under curves
timeFrame: 30 minutes after ingestion
measure: Areas under curves
timeFrame: 60 minutes after ingestion
measure: Areas under curves
timeFrame: 90 minutes after ingestion
measure: Areas under curves
timeFrame: 120 minutes after ingestion
measure: Areas under curves
timeFrame: 180 minutes after ingestion
measure: Areas under curves
timeFrame: 240 minutes after ingestion
measure: Areas under curves
timeFrame: 300 minutes after ingestion
measure: Areas under curves
timeFrame: 360 minutes after ingestion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre de Recherche en Nutrition Clinique d'Auvergne
state: Auvergne
Study officials:
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Marine Gueugneau, Phd
role: STUDY_DIRECTOR
References: