Bioavailability of Legume Proteins in Differents Products

NCT ID: NCT06624033

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-22
• Study Completion Date: 2023-09-22

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.

Conditions

Healthy; Men

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Chocolate cake with peas

the subjects will consume the test meals (arm title)

Group Type: EXPERIMENTAL

amino acids kinetics

Intervention Type: OTHER

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.

Biscuit with peas

the subjects will consume the test meals (arm title).

Group Type: EXPERIMENTAL

amino acids kinetics

Intervention Type: OTHER

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.

chopped steack with peas

the subjects will consume the test meals (arm title).

Group Type: EXPERIMENTAL

amino acids kinetics

Intervention Type: OTHER

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.

Chocolate cake with gluten

the subjects will consume the test meals (arm title)

Group Type: PLACEBO_COMPARATOR

amino acids kinetics

Intervention Type: OTHER

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.

biscuit with gluten

the subjects will consume the test meals (arm title).

Group Type: PLACEBO_COMPARATOR

amino acids kinetics

Intervention Type: OTHER

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.

chopped steack

the subjects will consume the test meals (arm title).

Group Type: PLACEBO_COMPARATOR

amino acids kinetics

Intervention Type: OTHER

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.

Interventions

amino acids kinetics

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role: collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role: lead

Responsible Party

Adeline BLOT

Clinical Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marine Gueugneau, Phd

Role: STUDY_DIRECTOR

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Locations

Centre de Recherche en Nutrition Clinique d'Auvergne

Clermont-Ferrand, Auvergne, France

Countries

France

Other Identifiers

CRNH 1 -2020

Identifier Type: -

Identifier Source: org_study_id