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

NCT05711095 | Completed DMC

• 1 other identifier: METC 22-049
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Muscle Protein Synthesis; Sarcopenia

Keywords

Muscle metabolism; Dietary protein; Plant protein

Outcome Measures

Primary Outcomes (1)

• Postprandial muscle protein fractional synthesic rate

  Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.

  0-4 hours

Secondary Outcomes (4)

• Postabsorptive ('basal') muscle protein fractional synthesis rate

  -3 - 0 hours

• Plasma amino acids concentrations

  0-4 hours

• Plasma glucose concentrations

  0-4 hours

• Plasma insulin concentrations

  0-4 hours

Other Outcomes (9)

• Age in years

  Baseline

• Bodymass in kg

  Baseline

• Height in m

  Baseline

Study Arms (3)

Fortified plant protein blend

EXPERIMENTAL

20g of plant-based protein blend fortified with 2 g leucine

Dietary Supplement: Fortified plant-based protein blend

Normal plant protein blend

EXPERIMENTAL

20g of plant-based protein blend

Dietary Supplement: Plant-based protein blend

Whey protein

ACTIVE COMPARATOR

20g of whey protein

Dietary Supplement: Whey protein

Interventions

Fortified plant-based protein blend DIETARY_SUPPLEMENT

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

Fortified plant protein blend

Plant-based protein blend DIETARY_SUPPLEMENT

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

Normal plant protein blend

Whey protein DIETARY_SUPPLEMENT

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

Whey protein

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male sex
• Aged between 60 and 85 y inclusive
• BMI between 18.5 and 35 kg/m2

You may not qualify if:

• Vegetarian and vegan diet
• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Danone Nutricia: collaborator

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Luc van Loon, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization of interventional drinks will be performed by an independent researcher who will also prepare the drinks on the morning of the test day. Drinks will be prepared in a non-transparent shaker and matched for taste.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 2, 2023
• Study Start: September 21, 2023
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)