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Not yet recruiting NCT07556029

Optimal Protein Intake to Maximize Whole-Body Protein Balance in Healthy Adults

No phase Interventional Protein Metabolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amino Acid.
Who it may be relevant to
Registry conditions: Protein Metabolism. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The purpose of this study is to assess the optimal protein intake to maximize whole-body protein net balance in healthy adults. In a randomized, double-blinded, crossover design, 12 young, healthy adult males and females aged 18-35 years, will consume a test diet consisting of free amino acid mixtures based on milk protein that vary in protein content 7 separate acute metabolic trials. The main study endpoint is optimal protein intake based on the lowest protein intake that maximizes whole-body protein net balance.

Interventions

  • Dietary supplement Amino Acid
    Test diet consisting of free amino acid mixtures based on milk protein.

Primary outcome measures

  • Optimal protein intake [Time frame: From enrolment through to study completion, minimum 7 weeks]

Eligibility criteria

Inclusion criteria

  • Aged between 18-35 years
  • BMI between 18.5-30 kg/m2
  • Healthy, recreationally active (exercise at least once per two weeks and a maximum of four days 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., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications)
  • Chronic use of gastric acid-suppressing medication or anti-coagulants
  • Unstable weight over the last three months
  • Diagnosed GI tract disorders or diseases
  • Blood donation in the past 2 months
  • Females: pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Netherlands · 1 center
  • Maastricht University Medical Centre+ — Maastricht

Identifiers

NCT: NCT07556029 · METC 24-031 · NL87239.068.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗