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OpenTrials
Completed

NCT Number: NCT06403137

Plant Protein Blend and Milk Protein Supplements in 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.

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.

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Key information

Conditions

Sarcopenia Atrophy Kwashiorkor Malnutrition Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Protein Malnutrition Severe Acute Malnutrition Signs and Symptoms Skeletal Muscle Atrophy

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance exercise

Behavioral

4 single-leg exercise sessions

Other names: Strength exercise, Resistance training

Standardized diet

Behavioral

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

Plant protein supplement

Dietary Supplement

Dissolved in water with breakfast and prior to sleep.

Maltodextrin supplement

Dietary Supplement

Dissolved in water with breakfast and prior to sleep.

Milk protein supplement

Dietary Supplement

Dissolved in water with breakfast and prior to sleep.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 10 days

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

  2. Dietary protein intake

    Time frame: 10 days

    Assessed by calculating the actual intakes from the provided diet

  3. Dietary fat intake

    Time frame: 10 days

    Assessed by calculating the actual intakes from the provided diet

  4. Dietary carbohydrate intake

    Time frame: 10 days

    Assessed by calculating the actual intakes from the provided diet

  5. Step count

    Time frame: 10 days

    Assessed using a accelerometer

  6. Muscle Crosssectional are

    Time frame: 10 days

    Assessed using Ultrasound

Other outcomes

  1. Age (year)

    Time frame: At baseline

    Interview question

  2. Body mass (kg)

    Time frame: At baseline

    Assessed using scale

  3. Height (m)

    Time frame: At baseline

    Assessed using stadiometer

  4. Body fat %

    Time frame: At baseline

    Assessed using Dexa scan

  5. Lean body mass (kg)

    Time frame: At baseline

    Assessed using Dexa scan

  6. Appendicular lean mass (kg)

    Time frame: At baseline

    Assessed using Dexa scan

  7. Sex

    Time frame: At baseline

    Biological sex checked using interview

  8. Systolic and diastolic blood pressure

    Time frame: At baseline

    Automated measurement

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Cargill

Registry information

Official study 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

Acronym: Blend-D2O

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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