Bioavailability of Pea Protein in Young and Old Volunteers

Healthy Male Volunteers Clinical Trial

— NUTRALYS  

Official title:

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".

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06381869
• Other study ID #: CRNHA 2018-2
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: June 13, 2019

Study information

• Verified date: April 2024
• Source: Roquette Freres
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 13, 2019
• Est. primary completion date: June 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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,

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
Roquette Freres	CRNH Auvergne, Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leucine blood concentration		0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Secondary	Essential amino acids blood concentration (µmol/L)		0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Secondary	Non essential amino acid blood concentration (µmol/L)		0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Secondary	Blood glucose concentration (g/L)		0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Secondary	Blood insulin concentration (µIU/ml)		0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Secondary	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.
Secondary	Blood inflammatory profile (TNF-a 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.