Bioavailability of Protein and Amino Acids From Oilseeds in Healthy Volunteers

NCT04024605 | Unknown DMC

• 1 other identifier: PRODIGE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to determine in healthy subjects the bioavailability of protein and amino acids of 4 protein sources: sunflower, rapeseed, lupin, flax. For this purpose, the investigators will compare two methods:

1. 1.the standard method consisting in measuring the ileal digestibility using ileal tubes
2. 2.an alternative method that has been proposed by an Food and Agriculture Organization (FAO) expert group: the dual isotope method

Conditions

Protein

Outcome Measures

Primary Outcomes (6)

• Percentage of ileal digestibility of plant proteins

  Total N and 15N will be measured by Elemental Analyzer coupled to an Isotopic Ratio Mass Spectrometer (EA-IRMS) and the percentage of dietary N reaching the terminal ileum will be then determined. This percentage will be corrected by the ileal flow rate which is estimated with measurement of PEG concentration in effluents by a turbidimetric methods. Ileal digestibility of plant proteins (i.e. N digestibility) will be calculated as 100 - corrected dietary N percentage.

  time -30 minutes to 8 hours after the meal

• Percentage of ileal digestibility of amino acids from plant proteins

  Amino acid concentrations will be measured by Ultra high performance liquid chromatography (UHPLC) and 15N, 2H and 13C enrichment in individual amino acids will be measured by Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS) in order to determine the percentage of dietary individual amino acids reaching the terminal ileum. This percentage will be corrected by the ileal flow rate which is estimated with measurement of PEG concentration in effluents by a turbidimetric methods. Ileal digestibility of plant amino acid will be calculated as 100 - corrected dietary amino acid percentage.

  time -30 minutes to 8 hours after the meal

• Percentage of net postprandial protein utilization of plant proteins

  Urea in plasma and urine (by enzymatic methods) will be determined and associated with 15N enrichment values (by EA IRMS) to determine the 15N transfer in plasma and urinary N pools and calculate the net postprandial protein utilization.

  time -30 minutes to 8 hours after the meal

• Postprandial plasma kinetics of dietary amino acids

  Amino acids in plasma will be determined by UHPLC and associated with 15N enrichment values in individual amino acids (by GC C IRMS) to determined the kinetics of amino acids from plant proteins.

  time -30 minutes to 8 hours after the meal

• Postprandial metabolism of glucose 1

  Glycemia (by enzymatic methods) will be determined in plasma.

  time -30 minutes to 8 hours after the meal

• Postprandial metabolism of glucose 2

  Insulinemia (by ELISA) will be determined in plasma.

  time -30 minutes to 8 hours after the meal

Secondary Outcomes (1)

• Validation of the dual isotope method to assess the bioavailability of individual amino acids

  time -30 minutes to 8 hours after the meal

Study Arms (4)

Sunflower

EXPERIMENTAL

Biscuits containing sunflower isolate intrinsically labelled with 15N and 2H

Dietary Supplement: Sunflower

Rapeseed

EXPERIMENTAL

Biscuits containing rapeseed isolate intrinsically labelled with 15N and 2H

Dietary Supplement: Rapeseed

Flaxseed

EXPERIMENTAL

Biscuits containing flaxseed isolate intrinsically labelled with 15N and 2H

Dietary Supplement: Flaxseed

Lupin

EXPERIMENTAL

Biscuits containing lupin flour intrinsically labelled with 15N and 2H

Dietary Supplement: Lupin

Interventions

Sunflower DIETARY_SUPPLEMENT

Plant proteins are intrinsically enriched with 15N and 2H. There are incorporated into biscuits. The biscuits are formulated to supply 20 g of plant protein per volunteer.

Sunflower

Rapeseed DIETARY_SUPPLEMENT

Plant proteins are intrinsically enriched with 15N and 2H. There are incorporated into biscuits. The biscuits are formulated to supply 20 g of plant protein per volunteer.

Rapeseed

Flaxseed DIETARY_SUPPLEMENT

Plant proteins are intrinsically enriched with 15N and 2H. There are incorporated into biscuits. The biscuits are formulated to supply 20 g of plant protein per volunteer.

Flaxseed

Lupin DIETARY_SUPPLEMENT

Plant proteins are intrinsically enriched with 15N and 2H. There are incorporated into biscuits. The biscuits are formulated to supply 20 g of plant protein per volunteer.

Lupin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<BMI\<30
• Healthy
• Insured under the French social security system
• for women: use of birth control
• signed informed consent

You may not qualify if:

• Any dietary allergy
• Latex allergy
• Positive serology to HIV, hepatite C virus antibody, hepatite B virus surface antigen and core antibodies
• Gluten intolerance
• Anemia
• Abusive use of drugs or alcohol
• Hypertension, diabetes, digestive disease, hepatic or renal disease, severe cardiac disease
• Pregnancy
• High sport practicing (\>7h/wk)
• Blood donation in the 3 months prior to the study
• Participation in a clinical study in the 3 months prior to the study
• No signed informed consent

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead
• AgroParisTech: collaborator

Study Sites (1)

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

Bobigny, Île-de-France Region, 93000, France

RECRUITING

Related Publications (2)

• Tessier R, Calvez J, Airinei G, Khodorova N, Dauguet S, Galet O, Chapelais M, Tome D, Benamouzig R, Gaudichon C. Digestive and metabolic bioavailability in healthy humans of 15N-labeled rapeseed and flaxseed protein incorporated in biscuits. Am J Clin Nutr. 2023 May;117(5):896-902. doi: 10.1016/j.ajcnut.2023.02.020. Epub 2023 Feb 24.

  PMID: 36842754 DERIVED

• Tessier R, Calvez J, Airinei G, Khodorova N, Kapel R, Quinsac A, Galet O, Piedcoq J, Benamouzig R, Tome D, Gaudichon C. The True Amino Acid Digestibility of 15N-Labelled Sunflower Biscuits Determined with Ileal Balance and Dual Isotope Methods in Healthy Humans. J Nutr. 2022 Mar 3;152(3):698-706. doi: 10.1093/jn/nxab423.

  PMID: 34910189 DERIVED

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Central Study Contacts

Claire GAUDICHON, Prof

CONTACT

33144081829; claire.gaudichon@agroapristech.fr

Gheorghe Airinei, MD

CONTACT

33680599291; gheorghe.airinei@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: July 18, 2019
• Study Start: January 15, 2019
• Primary Completion: December 30, 2020
• Study Completion: March 30, 2021
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

FR (1)