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Completed

NCT Number: NCT06381869

Bioavailability of Pea Protein in Young and Old Volunteers

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.

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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Clermont-Ferrand, 63009, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Leucine blood concentration

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

Secondary outcomes

  1. Essential amino acids blood concentration (µmol/L)

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

  2. Non essential amino acid blood concentration (µmol/L)

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

  3. Blood glucose concentration (g/L)

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

  4. Blood insulin concentration (μIU/ml)

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

  5. Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l)

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

  6. Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml)

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

Sponsors and collaborators

Lead sponsor

Roquette Freres

Industry

Collaborators

  • Centre de Recherche en Nutrition Humaine d'Auvergne
  • Université d'Auvergne

Registry information

Official study 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".

Acronym: NUTRALYS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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