Plant Protein Blend and Milk Protein Supplements in Older Individuals

NCT06403137 | Completed

• 1 other identifier: NL85365.068.23 / METC23-050
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Background Protein intake is important for skeletal muscle mass maintenance with aging and the ingestion of specifically-timed protein supplements could increase overall protein intake and thereby contribute to skeletal muscle mass maintenance. Recently, more attention has been given to the ingestion of plant-based protein blends as a more sustainable high-quality alternative to milk protein, as a means to increase muscle protein build-up and, as such, support muscle maintenance, especially when consuming suboptimal amounts of protein in the regular diet. Objective To assess the benefit of daily protein supplementation with either a plant-based protein blend or a milk protein on top of a standard diet to stimulate integrated muscle protein synthesis rates in healthy older individuals with and without exercise. Hypotheses It is hypothesized that both the plant protein blend and the milk protein supplement will result in greater muscle protein build-up when compared with a standard diet control condition. It is also hypothesized that exercise will result in greater muscle protein build-up when compared to the resting leg in all conditions, with similar effects of the protein supplements vs the control diet as in the non-exercised leg. This study will show the potential benefit of protein supplementation with alternative protein sources to support skeletal muscle maintenance in older individuals.

Conditions

Sarcopenia; Skeletal Muscle Atrophy; Protein Malnutrition

Keywords

Muscle protein synthesis

Outcome Measures

Primary Outcomes (1)

• Integrated muscle protein synthesis rates in the non-exercised leg.

  Calculated by the changein deuterium labelled alanine in skeletal muscle protein

  10 days

Secondary Outcomes (6)

• Integrated muscle protein synthesis rates in the exercised leg.

  10 days

• Dietary protein intake

  10 days

• Dietary fat intake

  10 days

• Dietary carbohydrate intake

  10 days

• Step count

  10 days

Other Outcomes (8)

• Age (year)

  At baseline

• Body mass (kg)

  At baseline

• Height (m)

  At baseline

Study Arms (3)

Maltodextrin

PLACEBO COMPARATOR

daily 2 x 20g maltodextrin ingestion

Behavioral: Resistance exercise; Behavioral: Standardized diet; Dietary Supplement: Maltodextrin supplement

Milk protein

EXPERIMENTAL

daily 2 x 20g milk protein ingestion

Behavioral: Resistance exercise; Behavioral: Standardized diet; Dietary Supplement: Milk protein supplement

Plant protein blend

EXPERIMENTAL

daily 2 x 20g plant protein blend ingestion

Behavioral: Resistance exercise; Behavioral: Standardized diet; Dietary Supplement: Plant protein supplement

Interventions

Resistance exercise BEHAVIORAL

4 single-leg exercise sessions

Also known as: Strength exercise, Resistance training

Maltodextrin; Milk protein; Plant protein blend

Standardized diet BEHAVIORAL

Fully standardized provided energy-balanced diet providing recommended daily allowance for protein.

Maltodextrin; Milk protein; Plant protein blend

Plant protein supplement DIETARY_SUPPLEMENT

Dissolved in water with breakfast and prior to sleep.

Plant protein blend

Maltodextrin supplement DIETARY_SUPPLEMENT

Dissolved in water with breakfast and prior to sleep.

Maltodextrin

Milk protein supplement DIETARY_SUPPLEMENT

Dissolved in water with breakfast and prior to sleep.

Milk protein

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female sex
• Aged between 60 and 80 y inclusive
• BMI between 18.5 and 30 kg/m2

You may not qualify if:

• Following a self-reported vegetarian and vegan diet the 6 months prior to the study.
• Intolerant to milk products
• Corn allergy
• Pea allergy
• Participating currently or in the 3 months prior to the study in a structured (progressive) exercise program.
• Smoking regularly (i.e. \>5 cigarettes/week)
• History of cardiovascular, respiratory, gastrointestinal, urogenital, neurological, psychiatric, dermatologic, musculoskeletal, metabolic, endocrine, haematological, immunologic disorders, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol, interfere with the execution of the experiment, or potential influence the study outcomes (to be decided by the principal investigator and responsible physician)
• Diagnosed with phenylketonuria (PKU)
• Uncontrolled hypertension (blood pressure above 160/100 mmHg)
• Donated blood 3 months prior to test day
• Use of any medications that interferes with study participation and/or outcomes (i.e. corticosteroids, non-steroidal anti-inflammatories, gastric acid suppressing medication) as assessed by the responsible medical doctor.
• Use of DOAC, vitamin-K-antagonist, or multiple anticoagulants
• Pregnancy

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Cargill: collaborator

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Kwashiorkor

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: Protein supplements are packed the same and look and taste similar.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, parallel-group trial.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: June 26, 2024
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)