Clinical trial NCT06381869: Bioavailability of Pea Protein in Young and Old Volunteers
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".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Male Volunteers
Keywords: Protein
Bioavailability
Pea protein
Amino acidemia
Lead sponsor: Roquette Freres
Sponsor class: INDUSTRY
Collaborators: name: Centre de Recherche en Nutrition Humaine d'Auvergne
name: Université d'Auvergne
First posted: 2024-04-24
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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,

Primary outcomes:
measure: Leucine blood concentration
timeFrame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Secondary outcomes:
measure: Essential amino acids blood concentration (µmol/L)
timeFrame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
measure: Non essential amino acid blood concentration (µmol/L)
timeFrame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
measure: Blood glucose concentration (g/L)
timeFrame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
measure: Blood insulin concentration (μIU/ml)
timeFrame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
measure: Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l)
timeFrame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
measure: Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml)
timeFrame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne
Study officials:
References: