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Plant Protein Blend and Milk Protein Supplements in Older Individuals

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06403137
Acronym
Blend-D2O
Enrollment
51
Registered
2024-05-07
Start date
2024-06-26
Completion date
2025-12-05
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein Malnutrition, Sarcopenia, Skeletal Muscle Atrophy

Keywords

Muscle protein synthesis

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.

Interventions

BEHAVIORALResistance exercise

4 single-leg exercise sessions

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.

Sponsors

Cargill
CollaboratorINDUSTRY
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Protein supplements are packed the same and look and taste similar.

Intervention model description

Randomized, controlled, parallel-group trial.

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Integrated muscle protein synthesis rates in the non-exercised leg.10 daysCalculated by the changein deuterium labelled alanine in skeletal muscle protein

Secondary

MeasureTime frameDescription
Dietary protein intake10 daysAssessed by calculating the actual intakes from the provided diet
Dietary fat intake10 daysAssessed by calculating the actual intakes from the provided diet
Dietary carbohydrate intake10 daysAssessed by calculating the actual intakes from the provided diet
Step count10 daysAssessed using a accelerometer
Muscle Crosssectional are10 daysAssessed using Ultrasound
Integrated muscle protein synthesis rates in the exercised leg.10 daysCalculated by the change in deuterium labelled alanine in skeletal muscle protein

Other

MeasureTime frameDescription
Body mass (kg)At baselineAssessed using scale
Height (m)At baselineAssessed using stadiometer
Body fat %At baselineAssessed using Dexa scan
Lean body mass (kg)At baselineAssessed using Dexa scan
Appendicular lean mass (kg)At baselineAssessed using Dexa scan
SexAt baselineBiological sex checked using interview
Systolic and diastolic blood pressureAt baselineAutomated measurement
Age (year)At baselineInterview question

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026