Plant Protein Blend and Milk Protein Supplements in Older Individuals

NCT ID: NCT06403137

Last Updated: 2025-12-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-26

Study Completion Date

2025-12-05

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Skeletal Muscle Atrophy Protein Malnutrition

Keywords

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Muscle protein synthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, parallel-group trial.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Protein supplements are packed the same and look and taste similar.

Study Groups

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Maltodextrin

daily 2 x 20g maltodextrin ingestion

Group Type PLACEBO_COMPARATOR

Maltodextrin supplement

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water with breakfast and prior to sleep.

Resistance exercise

Intervention Type BEHAVIORAL

4 single-leg exercise sessions

Standardized diet

Intervention Type BEHAVIORAL

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

Milk protein

daily 2 x 20g milk protein ingestion

Group Type EXPERIMENTAL

Milk protein supplement

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water with breakfast and prior to sleep.

Resistance exercise

Intervention Type BEHAVIORAL

4 single-leg exercise sessions

Standardized diet

Intervention Type BEHAVIORAL

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

Plant protein blend

daily 2 x 20g plant protein blend ingestion

Group Type EXPERIMENTAL

Plant protein supplement

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water with breakfast and prior to sleep.

Resistance exercise

Intervention Type BEHAVIORAL

4 single-leg exercise sessions

Standardized diet

Intervention Type BEHAVIORAL

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

Interventions

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Plant protein supplement

Dissolved in water with breakfast and prior to sleep.

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin supplement

Dissolved in water with breakfast and prior to sleep.

Intervention Type DIETARY_SUPPLEMENT

Milk protein supplement

Dissolved in water with breakfast and prior to sleep.

Intervention Type DIETARY_SUPPLEMENT

Resistance exercise

4 single-leg exercise sessions

Intervention Type BEHAVIORAL

Standardized diet

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Strength exercise Resistance training

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cargill

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Netherlands

Other Identifiers

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NL85365.068.23 / METC23-050

Identifier Type: -

Identifier Source: org_study_id