NCT07155824

Brief Summary

To gain mechanistic insights by examining the impact of innovative plant-protein fibre products, physical activity interventions on digestibility, amino acid bioavailability and whole-body protein metabolism in older persons

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Aug 2025Feb 2027

First Submitted

Initial submission to the registry

July 22, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

July 22, 2024

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Splanchnic extraction of amino acids

    Change in splanchnic extraction of amino acids in response to standardized test meals (vegetal \& animal proteins), assessed before and after a 12-week physical activity program.

    At baseline (Week 0) and at follow-up (Weeks 12-13).

Secondary Outcomes (2)

  • Whole body protein metabolism

    At baseline (Week 0) and at follow-up (Weeks 12-13).

  • Skeletal muscle signaling markers

    At baseline (Week 0) and at follow-up (Weeks 12-13) following only the plant protein standardized meal

Study Arms (1)

Dietary proteins and physical activity

EXPERIMENTAL

Effect of physical activity program on protein metabolism following ingestion of whey or plant protein blend

Dietary Supplement: Whey and plant protein blend

Interventions

The 12 week intervention will involve 2 weekly group exercise sessions incorporating strength and balance exercises, along with home-based exercise focused on increasing time spent walking.

Also known as: Physical activity
Dietary proteins and physical activity

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • BMI 22-30 kg/m²
  • Inactive (\<150 minutes of moderate to vigorous physical activity per week and no regular resistance training),
  • Covered by a social security system
  • Agrees to undergo the study interventions (undirect calorimetry, functional tests, physical activity program)

You may not qualify if:

  • Hamilton HAD scale with a score \> 9
  • Subject with a pathology or treatment (diabetic on insulin, corticosteroids \> 8 days, neuroleptics, anticoagulant, antiplatelet) judged by the investigator as incompatible with the study
  • Subject with unstabilized thyroid dysfunction for at least 3 months
  • Subject with unstabilized hypertension for at least 3 months
  • Subject with a medical and/or surgical history judged by the investigator as incompatible with the trial
  • More than 21 alcoholic drinks per week
  • Heavy smoker (\>10 cigarettes/day)
  • Currently participating in another intervention study
  • Absence of informed consent
  • Inability to participate in physical activity
  • Allergy(ies) or refusal to consume one of the foods tested as part of the the study
  • Allergy to local anesthetics
  • Declared glaucoma
  • Prostate hypertrophy
  • Refusal to register in the national file of volunteers who participate in research involving human beings
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Interventions

WheyExercise

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yves Boirie

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Controled, monocentric, open label study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2024

First Posted

September 4, 2025

Study Start

August 26, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations