SarcopeniaBlend-D2ONCT06403137
Plant Protein Blend and Milk Protein Supplements in Older Individuals
A study testing Resistance exercise, Standardized diet and Plant protein supplement in people with Sarcopenia and Skeletal Muscle Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Skeletal Muscle Atrophy, Protein Malnutrition
- What is being tested?
- Resistance exercise, Standardized diet and Plant protein supplement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jun 2024to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female sex
- Aged between 60 and 80 y inclusive
- BMI between 18.5 and 30 kg/m2
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
About this study
Official title: The Effectiveness of Daily Protein Supplementation With a Plant Protein Blend or Milk Protein to Support Integrated Muscle Protein Synthesis Rates With and Without Exercise in Healthy Older Individuals
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.
Read more
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
- Being tested
- Resistance exercise, Standardized diet, Plant protein supplement, Maltodextrin supplement, Milk protein supplement
- Keywords
- Muscle protein synthesis
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseBehavioural
Also called Strength exercise, Resistance training
4 single-leg exercise sessions
Standardized dietBehavioural
Fully standardized provided energy-balanced diet providing recommended daily allowance for protein.
Plant protein supplementDietary supplement
Dissolved in water with breakfast and prior to sleep.
Maltodextrin supplementDietary supplement
Dissolved in water with breakfast and prior to sleep.
Milk protein supplementDietary supplement
Dissolved in water with breakfast and prior to sleep.
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | daily 2 x 20g maltodextrin ingestion Receives: Behavioral: Resistance exercise; Behavioral: Standardized diet; Dietary Supplement: Maltodextrin supplement |
| Milk protein | Experimental | daily 2 x 20g milk protein ingestion Receives: Behavioral: Resistance exercise; Behavioral: Standardized diet; Dietary Supplement: Milk protein supplement |
| Plant protein blend | Experimental | daily 2 x 20g plant protein blend ingestion Receives: Behavioral: Resistance exercise; Behavioral: Standardized diet; Dietary Supplement: Plant protein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated muscle protein synthesis rates in the non-exercised leg.
Calculated by the changein deuterium labelled alanine in skeletal muscle protein
Measured: 10 days
Secondary outcomes (6)
Integrated muscle protein synthesis rates in the exercised leg.
Calculated by the change in deuterium labelled alanine in skeletal muscle protein
Measured: 10 days
Dietary protein intake
Assessed by calculating the actual intakes from the provided diet
Measured: 10 days
Dietary fat intake
Assessed by calculating the actual intakes from the provided diet
Measured: 10 days
Dietary carbohydrate intake
Assessed by calculating the actual intakes from the provided diet
Measured: 10 days
Step count
Assessed using a accelerometer
Measured: 10 days
Muscle Crosssectional are
Assessed using Ultrasound
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start26 Jun 2024
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel-group trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403137
- Sponsor's protocol ID
- NL85365.068.23 / METC23-050
- Acronym
- Blend-D2O
- Status last verified
- Dec 2025
- First submitted
- 3 May 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Daily Protein Supplementation With a Plant Protein Blend or Milk Protein to Support Integrated Muscle Protein Synthesis Rates With and Without Exercise in Healthy Older Individuals
- ClinicalTrials.gov ID
- NCT06403137
- Acronym / sponsor ID
- Blend-D2O / NL85365.068.23 / METC23-050
- Conditions
- Sarcopenia, Skeletal Muscle Atrophy, Protein Malnutrition
- Keywords
- Muscle protein synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, controlled, parallel-group trial.
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Behavioral: Resistance exercise, Behavioral: Standardized diet, Dietary Supplement: Maltodextrin supplementdaily 2 x 20g maltodextrin ingestion |
| Milk protein | Experimental | Behavioral: Resistance exercise, Behavioral: Standardized diet, Dietary Supplement: Milk protein supplementdaily 2 x 20g milk protein ingestion |
| Plant protein blend | Experimental | Behavioral: Resistance exercise, Behavioral: Standardized diet, Dietary Supplement: Plant protein supplementdaily 2 x 20g plant protein blend ingestion |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female sex
- Aged between 60 and 80 y inclusive
- BMI between 18.5 and 30 kg/m2
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exerciseAlso: Strength exercise, Resistance training4 single-leg exercise sessions | Behavioural | Maltodextrin, Milk protein, Plant protein blend |
| Standardized dietFully standardized provided energy-balanced diet providing recommended daily allowance for protein. | Behavioural | Maltodextrin, Milk protein, Plant protein blend |
| Plant protein supplementDissolved in water with breakfast and prior to sleep. | Dietary supplement | Plant protein blend |
| Maltodextrin supplementDissolved in water with breakfast and prior to sleep. | Dietary supplement | Maltodextrin |
| Milk protein supplementDissolved in water with breakfast and prior to sleep. | Dietary supplement | Milk protein |
Primary outcome
Integrated muscle protein synthesis rates in the non-exercised leg.
Time frame: 10 days
Calculated by the changein deuterium labelled alanine in skeletal muscle protein
6 secondary outcomes
Integrated muscle protein synthesis rates in the exercised leg.
Time frame: 10 days
Dietary protein intake
Time frame: 10 days
Dietary fat intake
Time frame: 10 days
Dietary carbohydrate intake
Time frame: 10 days
Step count
Time frame: 10 days
Muscle Crosssectional are
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc van Loon, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise, Standardized diet and Plant protein supplement in people with Sarcopenia and Skeletal Muscle Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated muscle protein synthesis rates in the non-exercised leg. (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.