Plant Protein Blend and Milk Protein Supplements in Older Individuals

Sarcopenia Clinical Trial

— Blend-D2O  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403137
• Other study ID #: NL85365.068.23 / METC23-050
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: Maastricht University Medical Center
• Contact: Wesley Hermans, MSc
• Phone: 0031433881810
• Email: w.hermans[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Muscular Atrophy
• Protein Malnutrition
• Sarcopenia
• Skeletal Muscle Atrophy

Intervention

Behavioral:
• Resistance exercise
4 single-leg exercise sessions
• Standardized diet
Fully standardized provided energy-balanced diet providing recommended daily allowance for protein.

Dietary Supplement:
• Plant protein supplement
Dissolved in water with breakfast and prior to sleep.
• Maltodextrin supplement
Dissolved in water with breakfast and prior to sleep.
• Milk protein supplement
Dissolved in water with breakfast and prior to sleep.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Cargill

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age (year)	Interview question	At baseline
Other	Body mass (kg)	Assessed using scale	At baseline
Other	Height (m)	Assessed using stadiometer	At baseline
Other	Body fat %	Assessed using Dexa scan	At baseline
Other	Lean body mass (kg)	Assessed using Dexa scan	At baseline
Other	Appendicular lean mass (kg)	Assessed using Dexa scan	At baseline
Other	Sex	Biological sex checked using interview	At baseline
Other	Systolic and diastolic blood pressure	Automated measurement	At baseline
Primary	Integrated muscle protein synthesis rates in the non-exercised leg.	Calculated by the changein deuterium labelled alanine in skeletal muscle protein	10 days
Secondary	Integrated muscle protein synthesis rates in the exercised leg.	Calculated by the change in deuterium labelled alanine in skeletal muscle protein	10 days
Secondary	Dietary protein intake	Assessed by calculating the actual intakes from the provided diet	10 days
Secondary	Dietary fat intake	Assessed by calculating the actual intakes from the provided diet	10 days
Secondary	Dietary carbohydrate intake	Assessed by calculating the actual intakes from the provided diet	10 days
Secondary	Step count	Assessed using a accelerometer	10 days
Secondary	Muscle Crosssectional are	Assessed using Ultrasound	10 days