Bioavailability of Legume Proteins in Differents Products

NCT06624033 | Completed

• 1 other identifier: CRNH 1 -2020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Men

Keywords

amino acid; legume; pea; protein

Outcome Measures

Primary Outcomes (13)

• 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)

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  360 minutes after ingestion

Secondary Outcomes (73)

• Changes in the plasma concentrations of the others amino acids

  0 minute before the consumption of the test meals,

• Changes in the plasma concentrations of the others amino acids

  15 minutes after ingestion

• Changes in the plasma concentrations of the others amino acids

  30 minutes after ingestion

• Changes in the plasma concentrations of the others amino acids

  45 minutes after ingestion

• Changes in the plasma concentrations of the others amino acids

  60 minutes after ingestion

Study Arms (6)

Chocolate cake with peas

EXPERIMENTAL

the subjects will consume the test meals (arm title)

Other: amino acids kinetics

Biscuit with peas

EXPERIMENTAL

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

Other: amino acids kinetics

chopped steack with peas

EXPERIMENTAL

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

Other: amino acids kinetics

Chocolate cake with gluten

PLACEBO COMPARATOR

the subjects will consume the test meals (arm title)

Other: amino acids kinetics

biscuit with gluten

PLACEBO COMPARATOR

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

Other: amino acids kinetics

chopped steack

PLACEBO COMPARATOR

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

Other: amino acids kinetics

Interventions

amino acids kinetics 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; Chocolate cake with gluten; Chocolate cake with peas; biscuit with gluten; chopped steack; chopped steack with peas

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator

Study Sites (1)

Centre de Recherche en Nutrition Clinique d'Auvergne

Clermont-Ferrand, Auvergne, 63009, France

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Marine Gueugneau, Phd

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-centre randomized, cross-over controlled trial.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Associate

Model Details: participants may receive 6 products in 6 interventions sequentially during the protocol

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: October 2, 2024
• Study Start: June 22, 2020
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2023
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

FR (1)