Bioavailability of Pea Protein in Young and Old Volunteers

NCT06381869 | Completed

• 1 other identifier: CRNHA 2018-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Volunteers

Keywords

Protein; Bioavailability; Pea protein; Amino acidemia

Outcome Measures

Primary Outcomes (1)

• Leucine blood concentration

  0 minute before eating the test meals, then regularly until 360 minutes after ingestion.

Secondary Outcomes (6)

• 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.

Study Arms (2)

Young volunteers

OTHER

Volunteers under 30 years old

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

Elderly volunteers

OTHER

Volunteers over 65 years old.

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

Interventions

Pea protein (NUTRALYS ® S85 plus) in water DIETARY_SUPPLEMENT

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.

Elderly volunteers; Young volunteers

Pea protein (NUTRALYS ® S85 plus) within meal DIETARY_SUPPLEMENT

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.

Elderly volunteers; Young volunteers

Whey protein in water DIETARY_SUPPLEMENT

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.

Elderly volunteers; Young volunteers

Whey protein within meal DIETARY_SUPPLEMENT

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.

Elderly volunteers; Young volunteers

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Roquette Freres: lead
• Université d'Auvergne: collaborator
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator

Study Sites (1)

Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne

Clermont-Ferrand, 63009, France

Location

MeSH Terms

Interventions

Pea Proteins; Whey Proteins; Water

Intervention Hierarchy (Ancestors)

Plant Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Milk Proteins; Animal Proteins, Dietary; Whey; Milk; Dairy Products; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Nutrition Exploration Unit, Clinical professor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 24, 2024
• Study Start: January 10, 2019
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

FR (1)