Plant Protein Blend and Milk Protein Supplements in Older Individuals

Not Applicable

Recruiting

• Conditions: Protein Malnutrition; Sarcopenia; Skeletal Muscle Atrophy
• Interventions: Behavioral: Resistance exercise; Behavioral: Standardized diet; Dietary Supplement: Milk protein supplement; Dietary Supplement: Maltodextrin supplement; Dietary Supplement: Plant protein supplement

• Registration Number: NCT06403137
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Study Start: 2024-06-20
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk protein	Resistance exercise	daily 2 x 20g milk protein ingestion
Milk protein	Milk protein supplement	daily 2 x 20g milk protein ingestion
Maltodextrin	Standardized diet	daily 2 x 20g maltodextrin ingestion
Maltodextrin	Maltodextrin supplement	daily 2 x 20g maltodextrin ingestion
Plant protein blend	Standardized diet	daily 2 x 20g plant protein blend ingestion
Plant protein blend	Plant protein supplement	daily 2 x 20g plant protein blend ingestion
Maltodextrin	Resistance exercise	daily 2 x 20g maltodextrin ingestion
Plant protein blend	Resistance exercise	daily 2 x 20g plant protein blend ingestion
Milk protein	Standardized diet	daily 2 x 20g milk protein ingestion

Primary Outcome Measures

Name	Time	Method
Integrated muscle protein synthesis rates in the non-exercised leg.	10 days	Calculated by the changein deuterium labelled alanine in skeletal muscle protein

Secondary Outcome Measures

Name	Time	Method
Dietary fat intake	10 days	Assessed by calculating the actual intakes from the provided diet
Step count	10 days	Assessed using a accelerometer
Dietary protein intake	10 days	Assessed by calculating the actual intakes from the provided diet
Integrated muscle protein synthesis rates in the exercised leg.	10 days	Calculated by the change in deuterium labelled alanine in skeletal muscle protein
Muscle Crosssectional are	10 days	Assessed using Ultrasound
Dietary carbohydrate intake	10 days	Assessed by calculating the actual intakes from the provided diet

Trial Locations

Locations (1)

Maastricht University Medical Center+; 🇳🇱 Maastricht, Limburg, Netherlands