Clinical trial NCT06403137: Plant Protein Blend and Milk Protein Supplements in Older Individuals
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Skeletal Muscle Atrophy
Protein Malnutrition
Keywords: Muscle protein synthesis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Cargill
First posted: 2024-05-07
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, parallel-group trial.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Integrated muscle protein synthesis rates in the non-exercised leg.
timeFrame: 10 days
Secondary outcomes:
measure: Integrated muscle protein synthesis rates in the exercised leg.
timeFrame: 10 days
measure: Dietary protein intake
timeFrame: 10 days
measure: Dietary fat intake
timeFrame: 10 days
measure: Dietary carbohydrate intake
timeFrame: 10 days
measure: Step count
timeFrame: 10 days
measure: Muscle Crosssectional are
timeFrame: 10 days
Other outcomes:
measure: Age (year)
timeFrame: At baseline
measure: Body mass (kg)
timeFrame: At baseline
measure: Height (m)
timeFrame: At baseline
measure: Body fat %
timeFrame: At baseline
measure: Lean body mass (kg)
timeFrame: At baseline
measure: Appendicular lean mass (kg)
timeFrame: At baseline
measure: Sex
timeFrame: At baseline
measure: Systolic and diastolic blood pressure
timeFrame: At baseline
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
Study officials:
affiliation: Maastricht University
name: Luc van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References: