Bioavailability of Protein and Amino Acids of Pea Protein Isolate in Healthy Volunteers

NCT04072770 | Completed DMC

• 1 other identifier: Qualipois
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to determine in healthy subjects the bioavailability of protein and amino acids of pea protein isolate and casein isolate. 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

Proteins

Keywords

Pea protein; Casein; Amino acid bioavailability; Protein digestibility; Isotopic tracers

Outcome Measures

Primary Outcomes (6)

• Percentage of ileal digestibility of pea proteins and casein

  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 pea proteins and casein (i.e. N digestibility) will be calculated as 100 - corrected dietary N percentage.

  -30 minute to 8 hours after the meal

• Percentage of ileal digestibility of amino acids from pea proteins and casein

  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 pea and casein amino acid will be calculated as 100 - corrected dietary amino acid percentage.

  -30 minute to 8 hours after the meal

• Percentage of net postprandial protein utilization of pea proteins and casein

  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 of pea protein and casein.

  -30 minute to 8 hours after the meal

• Postprandial concentration of dietary amino acids in plasma

  Concentration of individual amino acids (alanine, arginine, asparagine, aspartic acid, cystein, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, proline, phenylalanine, serine, threonine, valine, tryptophan, tyrosine) in plasma will be determined by UHPLC and associated with 15N enrichment values in individual amino acids (by GC C IRMS) to determined the concentration of dietary amino acids in plasma that comes from pea proteins and casein.

  -30 minute to 8 hours after the meal

• Postprandial concentration of glucose in plasma

  Concentration of glucose (by enzymatic assay) will be determined in plasma.

  -30 minute to 8 hours after the meal

• Postprandial concentration of insulin in plasma

  Concentration of insulin (by ELISA) will be determined in plasma.

  -30 minute to 8 hours after the meal

Secondary Outcomes (1)

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

  -30 minute to 8 hours after the meal

Study Arms (2)

Pea

EXPERIMENTAL

Mashed potatoes meal containing pea protein isolate intrinsically labelled with 15N and 2H

Dietary Supplement: Pea

Casein

ACTIVE COMPARATOR

Mashed potatoes meal containing casein isolate intrinsically labelled with 15N and 2H

Dietary Supplement: Casein

Interventions

Pea DIETARY_SUPPLEMENT

Proteins are intrinsically enriched with 15N and 2H. There are incorporated into mashed potatoes and the test meal is formulated to supply 30 g of pea protein per volunteer.

Pea

Casein DIETARY_SUPPLEMENT

Proteins are intrinsically enriched with 15N and 2H. There are incorporated into mashed potatoes and the test meal is formulated to supply 30 g of pea protein per volunteer.

Casein

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• 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
• Use of drugs
• High consumption of 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

Study Sites (1)

Centre de Recherche sur Volontaires (CRV)

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

Location

Related Publications (2)

• Guillin FM, Gaudichon C, Guerin-Deremaux L, Lefranc-Millot C, Airinei G, Khodorova N, Benamouzig R, Pomport PH, Martin J, Calvez J. Values for the Digestibility of Pea Protein Isolate or Casein Amino Acids Determined using the Dual Isotope Method Are Not Similar to Those Derived with the Standard Ileal Balance Method in Healthy Volunteers. J Nutr. 2024 Feb;154(2):516-525. doi: 10.1016/j.tjnut.2023.12.039. Epub 2023 Dec 29.

  PMID: 38160805 DERIVED

• Guillin FM, Gaudichon C, Guerin-Deremaux L, Lefranc-Millot C, Airinei G, Khodorova N, Benamouzig R, Pomport PH, Martin J, Calvez J. Real ileal amino acid digestibility of pea protein compared to casein in healthy humans: a randomized trial. Am J Clin Nutr. 2022 Feb 9;115(2):353-363. doi: 10.1093/ajcn/nqab354.

  PMID: 34665230 DERIVED

MeSH Terms

Interventions

Caseins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: July 16, 2019
• First Posted: August 28, 2019
• Study Start: June 19, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

FR (1)