The Anabolic Properties of Fortified Plant-based Protein in Older People
NCT ID: NCT05711095
Last Updated: 2025-05-06
Study Results
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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COMPLETED
NA
45 participants
INTERVENTIONAL
2023-09-21
2024-09-13
Brief Summary
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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.
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Detailed Description
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Conventional animal-based protein sources such as meat and dairy are generally considered high-quality sources of dietary protein because they meet all of the indispensable amino acid requirements for humans and are highly digestible. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands represents a massive challenge. Presently, there is a great interest in plant-based proteins as a more sustainable alternative for animal-based proteins. Current data shows that plant-based proteins are generally of a lesser quality when compared to animal-based protein, like whey protein, as evidenced by a lower indispensable amino acid content and deficiencies in one or more specific amino acids (i.e. lysine, leucine and/or methionine). This also translates to a compromised bioavailability and lesser anabolic properties. Studies show that ingestion of a single bolus of a plant protein increases muscle protein synthesis rates to a lesser extent when compared to animal-based proteins.
Combining different types of plant-derived proteins to overcome the amino acid deficiencies has been proposed as a strategy to increase the anabolic properties of plant-derived proteins. However, it is not possible to match the amino acid composition to that of the gold standard, whey protein. Another strategy to improve the anabolic properties of plant-derived proteins is fortification with free essential amino acids. Previously, ingestion of 40g of protein as a lysine fortified meat substitute was shown to increase muscle protein synthesis rates to a similar level as the ingestion of chicken. However, it is unclear whether this similarity was caused by the lysine enrichment or by the ingestion of a really high dose of protein that could have maximized muscle protein synthesis rates. Therefore, the principle of fortification is still to be investigated with the ingestion of a much lower (submaximal, but more realistic) dose of 20g protein.
Therefore, the aim of the current study is to assess postprandial muscle protein synthesis rates in older males in response to ingestion of a blend of plant protein (20g) fortified with free leucine, as compared to the blend of plant protein without additional leucine, and compared to whey protein as the gold standard.
Two primary hypotheses will be tested:
1. it is hypothesized that postprandial muscle protein synthesis rates will be higher following ingestion of the fortified plant protein blend when compared to the normal plant protein blend
2. it is hypothesized that postprandial muscle protein synthesis rates will be at least as high following ingestion of the fortified plant protein blend when compared to whey protein.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Fortified plant protein blend
20g of plant-based protein blend fortified with 2 g leucine
Fortified plant-based protein blend
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Normal plant protein blend
20g of plant-based protein blend
Plant-based protein blend
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Whey protein
20g of whey protein
Whey protein
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Interventions
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Fortified plant-based protein blend
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Plant-based protein blend
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Whey protein
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Eligibility Criteria
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Inclusion Criteria
* Aged between 60 and 85 y inclusive
* BMI between 18.5 and 35 kg/m2
Exclusion Criteria
* Intolerant to milk products
* Soy allergy
* Pea allergy
* Participating in a structured (progressive) exercise program
* Smoking regularly (i.e. \>5 cigarettes/week)
* Diagnosed GI tract disorders or diseases
* Diagnosed musculoskeletal disorders
* Diagnosed metabolic disorders (e.g. diabetes)
* Diagnosed with phenylketonuria (PKU)
* Uncontrolled hypertension (blood pressure above 160/100 mmHg)
* Donated blood 3 months prior to test day
* Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
* Chronic use of gastric acid suppressing medication
* Chronic use of anti-coagulants
* Recent (\<1 year) participation in amino acid tracer studies (L-\[ring-13C6\]-phenylalanine and L-\[3,5-2H2\]-tyrosine)
60 Years
85 Years
MALE
Yes
Sponsors
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Danone Nutricia
INDUSTRY
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Luc van Loon, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Maastricht University Medical Center+
Maastricht, Limburg, Netherlands
Countries
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Other Identifiers
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METC 22-049
Identifier Type: -
Identifier Source: org_study_id
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