NCT06783075

Brief Summary

Dietary protein intake is essential for tissue renewal and growth. Current recommendations for protein intake are based on studies using egg protein as reference protein. Egg protein is an animal-based protein with a high quality. Protein quality is determined by the composition of (essential) amino acids and digestibility. Therefore, different proteins have a different quality. Due to the environmental crisis, an increasing number of people consumes more plant-based proteins. These plant-based proteins often have a lower protein quality compared to animal-based proteins. Therefore, the aim of this study is to investigate whether optimal protein intake depend on protein quality. The optimal protein intake of an animal-based protein with a high quality (milk) will be compared to the optimal protein intake of a plant-based protein with a low quality (wheat).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2025Jan 2027

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

January 14, 2025

Last Update Submit

January 14, 2025

Conditions

Keywords

whole-body protein synthesis

Outcome Measures

Primary Outcomes (1)

  • Differences in protein intake to maximize whole-body protein synthesis rates in older adults based on consumption of milk protein or wheat protein

    From enrollment to the end of the study at 7 weeks

Secondary Outcomes (4)

  • Estimated Average Requirement (EAR) to maximize whole-body protein synthesis rates in healthy older adults based on milk protein

    From enrollment to the end of the study at 7 weeks

  • The Recommended Daily Allowance (RDA) to maximize whole-body protein synthesis rates in older adults based on milk protein

    From enrollment to the end of the study at 7 weeks

  • The Estimated Average Requirement (EAR) to maximize whole-body protein synthesis rates in older adults based on wheat protein

    From enrollment to the end of the study at 7 weeks

  • The Recommended Daily Allowance (RDA) to maximize whole-body protein synthesis rates in older adults based on wheat protein

    From enrollment to the end of the study at 7 weeks

Study Arms (2)

MILK

ACTIVE COMPARATOR

Drink containing amino acid composition of milk protein

Other: MILK

WHEAT

ACTIVE COMPARATOR

Drink containing amino acid composition of wheat protein

Other: WHEAT

Interventions

MILKOTHER

Drink containing amino acids in the composition of milk protein

MILK
WHEATOTHER

Drink containing amino acids in the composition of wheat protein

WHEAT

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged between 65-85 years
  • BMI between 18.5-30 kg\*m\^-2
  • Healthy, recreationally active (maximal one intensive exercise training per week)
  • No physical limitations (i.e., able to perform all activities associated with daily living independently)

You may not qualify if:

  • Smoking
  • Diagnosed musculoskeletal disorders
  • Use of any medications known to affect protein metabolism (i.e., corticosteriods, non-steroidal anti-inflammatories)
  • Chronic use of gastic acid-suppressing medication or anti-coagulants
  • Unstable weight over the last 3 months
  • Diagnosed GI tract disorders or diseases
  • Blood donation in the past 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Protein beverages with milk- or wheat composition will look similar.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Double-blind, randomized, parallel study design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 20, 2025

Record last verified: 2025-01

Locations