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CompletedNCT06403137Blend-D2OUpdated Dec 18, 2025

Plant Protein Blend and Milk Protein Supplements in Older Individuals

An interventional study of Resistance exercise and Standardized diet in Sarcopenia, Skeletal Muscle Atrophy and Protein Malnutrition, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sarcopenia
  • Skeletal Muscle Atrophy
  • Protein Malnutrition

Keywords

  • Muscle protein synthesis
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 51 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Placebo comparator
    Maltodextrin

    daily 2 x 20g maltodextrin ingestion

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

  • Experimental
    Milk protein

    daily 2 x 20g milk protein ingestion

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

  • Experimental
    Plant protein blend

    daily 2 x 20g plant protein blend ingestion

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

Interventions

  • BehavioralResistance exercise

    4 single-leg exercise sessions

    Also known as: Strength exercise, Resistance training

  • BehavioralStandardized diet

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

  • Dietary supplementPlant protein supplement

    Dissolved in water with breakfast and prior to sleep.

  • Dietary supplementMaltodextrin supplement

    Dissolved in water with breakfast and prior to sleep.

  • Dietary supplementMilk protein supplement

    Dissolved in water with breakfast and prior to sleep.

06

What researchers measure

Primary outcomes

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

    Calculated by the changein deuterium labelled alanine in skeletal muscle protein

    Time frame: 10 days

Secondary outcomes

  1. Integrated muscle protein synthesis rates in the exercised leg.

    Calculated by the change in deuterium labelled alanine in skeletal muscle protein

    Time frame: 10 days

  2. Dietary protein intake

    Assessed by calculating the actual intakes from the provided diet

    Time frame: 10 days

  3. Dietary fat intake

    Assessed by calculating the actual intakes from the provided diet

    Time frame: 10 days

  4. Dietary carbohydrate intake

    Assessed by calculating the actual intakes from the provided diet

    Time frame: 10 days

  5. Step count

    Assessed using a accelerometer

    Time frame: 10 days

  6. Muscle Crosssectional are

    Assessed using Ultrasound

    Time frame: 10 days

Other outcomes

  1. Age (year)

    Interview question

    Time frame: At baseline

  2. Body mass (kg)

    Assessed using scale

    Time frame: At baseline

  3. Height (m)

    Assessed using stadiometer

    Time frame: At baseline

  4. Body fat %

    Assessed using Dexa scan

    Time frame: At baseline

  5. Lean body mass (kg)

    Assessed using Dexa scan

    Time frame: At baseline

  6. Appendicular lean mass (kg)

    Assessed using Dexa scan

    Time frame: At baseline

  7. Sex

    Biological sex checked using interview

    Time frame: At baseline

  8. Systolic and diastolic blood pressure

    Automated measurement

    Time frame: At baseline

07

Study locations

1 site
  • Maastricht University Medical Center+
    Maastricht, Limburg 6229ER, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06403137
Lead sponsor
Maastricht University Medical Center
Collaborators
Cargill
Responsible party
Sponsor
First posted
May 7, 2024
Start date
Jun 26, 2024
Primary completion
Dec 5, 2025
Completion
Dec 5, 2025
Last update
Dec 18, 2025

Study contacts

Luc van Loon, PhD
principal investigator · Maastricht University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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