Bioavailability of Pea Protein in Young and Old Volunteers (NUTRALYS)

Study of Comparative Bioavailability, Randomized, in Open Cross Over the Kinetics of Subsequent Plasma Amino Acid Concentrations the Consumption of Pea Protein "NUTRALYS ® S85 Plus".

The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal.

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Dietary supplement: Pea protein (NUTRALYS ® S85 plus) in water; Dietary supplement: Pea protein (NUTRALYS ® S85 plus) within meal; Dietary supplement: Whey protein in water; Dietary supplement: Whey protein within meal

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63009
    • Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult male volunteers, aged over 65 or under 30
• Body mass index (weight in kg/ height² in m²) between 22 and 28 kg/m²,
• Subjects considered to be healthy by the principal investigator doctor according to the interview, medical and clinical examination,
• Biological assessment considered compatible with participation in the study,
• Persons able to sign the informed consent,
• Persons affiliated to social security scheme.

Exclusion Criteria:

• Pathologies or treatments not compatible with the study
• Food allergy or a contraindication to the consumption of the products tested
• Subject in a situation which, in the opinion of the investigator, could interfere with their optimal participation in the study or constitute a particular risk for the subject,
• Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
• Subject weighing < 55 kg,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Young volunteers; Volunteers under 30 years old	Dietary supplement: Pea protein (NUTRALYS ® S85 plus) in water; After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) in water containing 0,41 g of tested protein/kg of body weight.; Dietary supplement: Pea protein (NUTRALYS ® S85 plus) within meal; After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) within a meal containing 0,41 g of tested protein/kg of body weight.; Dietary supplement: Whey protein in water; After selection and randomization, the subjects will consume per os whey protein in water containing 0,41 g of tested protein/kg of body weight.; Dietary supplement: Whey protein within meal; After selection and randomization, the subjects will consume per os whey protein within a meal containing 0,41 g of tested protein/kg of body weight.
Other: Elderly volunteers; Volunteers over 65 years old.	Dietary supplement: Pea protein (NUTRALYS ® S85 plus) in water; After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) in water containing 0,41 g of tested protein/kg of body weight.; Dietary supplement: Pea protein (NUTRALYS ® S85 plus) within meal; After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) within a meal containing 0,41 g of tested protein/kg of body weight.; Dietary supplement: Whey protein in water; After selection and randomization, the subjects will consume per os whey protein in water containing 0,41 g of tested protein/kg of body weight.; Dietary supplement: Whey protein within meal; After selection and randomization, the subjects will consume per os whey protein within a meal containing 0,41 g of tested protein/kg of body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Leucine blood concentration	0 minute before eating the test meals, then regularly until 360 minutes after ingestion.

Secondary Outcome Measures

Outcome Measure	Time Frame
Essential amino acids blood concentration (µmol/L)	0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Non essential amino acid blood concentration (µmol/L)	0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood glucose concentration (g/L)	0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood insulin concentration (μIU/ml)	0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l)	0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml)	0 minute before eating the test meals, then regularly until 360 minutes after ingestion.

Collaborators and Investigators

• Sponsor: Roquette Frères
• Collaborators: Université d'Auvergne; CRNH Auvergne

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): June 13, 2019
• Study Completion (Actual): June 13, 2019

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bioavailability; Protein; Pea protein; Amino acidemia
• Other Study ID Numbers: CRNHA 2018-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No