Milk Vs Wheat Protein Intake to Maximize Whole-body Protein Synthesis Rates in Healthy Older Adults (Plant-IAAO)

January 14, 2025 updated by: Maastricht University Medical Center
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht University Medical Center+
        • Contact:
          • Loïs Reijnders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MILK
Drink containing amino acid composition of milk protein
Other: MILK
Drink containing amino acids in the composition of milk protein
Active Comparator: WHEAT
Drink containing amino acid composition of wheat protein
Other: WHEAT
Drink containing amino acids in the composition of wheat protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in protein intake to maximize whole-body protein synthesis rates in older adults based on consumption of milk protein or wheat protein
Time Frame: From enrollment to the end of the study at 7 weeks
From enrollment to the end of the study at 7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimated Average Requirement (EAR) to maximize whole-body protein synthesis rates in healthy older adults based on milk protein
Time Frame: From enrollment to the end of the study at 7 weeks
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
Time Frame: From enrollment to the end of the study at 7 weeks
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
Time Frame: From enrollment to the end of the study at 7 weeks
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
Time Frame: From enrollment to the end of the study at 7 weeks
From enrollment to the end of the study at 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • METC 24-051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be made available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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