The Anabolic Properties of Fortified Plant-based Protein in Older People

NCT05711095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-05-06

No results posted yet for this study

Summary

Rationale: Consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. Conventional animal-based protein sources such as meat, poultry, fish, eggs, and dairy are considered high-quality sources of dietary protein. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands will be challenging. Consequently, there is a great interest in more sustainable alternatives for these high-quality protein sources. Plant-derived proteins can be produced on a more sustainable scale, but are generally considered lower quality protein sources compared to animal-based sources because of incomplete essential amino acid profiles, resulting in lower anabolic properties for skeletal muscle building. Blending different plant-derived proteins can be a solution, but will never match the profile of other high-quality animal-derived proteins, likely necessitating the fortification of such plant-based protein blends with essential amino acids such as leucine.

Objective: To assess post-prandial muscle protein synthesis rates in older males in response to ingesting a blend of plant protein fortified with free leucine compared to (gold standard) whey protein and compared to the plant protein blend without additional leucine.

Study design: randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial.

Study population: 45 healthy (BMI 18.5-35 kg/m2) older males (age: 60-85 y inclusive).

Intervention: Subjects will consume a beverage containing 20g whey protein isolate, 20g of a plant protein blend or the same plant protein blend fortified with 2g leucine. Continuous intravenous stable isotope amino acid tracer infusions will be applied, with plasma and muscle samples collected at different time points throughout the experimental test day.

Main study parameters/endpoints: The primary outcome will be postprandial (0-4h) muscle protein synthesis rates following beverage ingestion.

Conditions

Interventions

DIETARY_SUPPLEMENT

Fortified plant-based protein blend

20 grams of protein dissolved in 500 mL water from a non-transparent shaker

DIETARY_SUPPLEMENT

Plant-based protein blend

20 grams of protein dissolved in 500 mL water from a non-transparent shaker

DIETARY_SUPPLEMENT

Whey protein

20 grams of protein dissolved in 500 mL water from a non-transparent shaker

Sponsors & Collaborators

  • Danone Nutricia

    collaborator INDUSTRY
  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Luc van Loon, PhD · Maastricht University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2024-09-13
Completion
2024-09-13

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05711095 on ClinicalTrials.gov