Bioavailability of Pea Protein in Young and Old Volunteers

NCT ID: NCT06381869

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2019-06-13

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Young volunteers

Volunteers under 30 years old

Group Type OTHER

Pea protein (NUTRALYS ® S85 plus) in water

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Volunteers over 65 years old.

Group Type OTHER

Pea protein (NUTRALYS ® S85 plus) in water

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role collaborator

Université d'Auvergne

OTHER

Sponsor Role collaborator

Roquette Freres

INDUSTRY

Sponsor Role lead

Responsible Party

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Ruddy Richard

Director of the Nutrition Exploration Unit, Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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CRNHA 2018-2

Identifier Type: -

Identifier Source: org_study_id

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