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

NCT07556029 | Not Yet Recruiting DMC

• 2 other identifiers: METC 24-031NL87239.068.24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Protein Metabolism

Outcome Measures

Primary Outcomes (1)

• Optimal protein intake

  The optimal protein intake to maximize whole-body protein synthesis rates in healthy, young males and females based on the consumption of milk protein.

  From enrolment through to study completion, minimum 7 weeks

Study Arms (7)

0.4 g protein･kg BM-1･d-1

EXPERIMENTAL

Dietary Supplement: Amino Acid

0.6 g protein･kg BM-1･d-1

EXPERIMENTAL

Dietary Supplement: Amino Acid

0.8 g protein･kg BM-1･d-1

EXPERIMENTAL

Dietary Supplement: Amino Acid

1.0 g protein･kg BM-1･d-1

EXPERIMENTAL

Dietary Supplement: Amino Acid

1.2 g protein･kg BM-1･d-1

EXPERIMENTAL

Dietary Supplement: Amino Acid

1.5 g protein･kg BM-1･d-1

EXPERIMENTAL

Dietary Supplement: Amino Acid

1.8 g protein･kg BM-1･d-1

EXPERIMENTAL

Dietary Supplement: Amino Acid

Interventions

Amino Acid DIETARY_SUPPLEMENT

Test diet consisting of free amino acid mixtures based on milk protein.

0.4 g protein･kg BM-1･d-1; 0.6 g protein･kg BM-1･d-1; 0.8 g protein･kg BM-1･d-1; 1.0 g protein･kg BM-1･d-1; 1.2 g protein･kg BM-1･d-1; 1.5 g protein･kg BM-1･d-1; 1.8 g protein･kg BM-1･d-1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6200 MD, Netherlands

Location

MeSH Terms

Interventions

Amino Acids

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Luc JC van Loon, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia M Malowany, MSc

CONTACT

+31 43 388 1617; julia.malowany@maastrichtuniversity.nl

Jorn Trommelen, PhD

CONTACT

+31 43 388 1617; jorn.trommelen@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject, randomized, double-blinded, crossover design

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

NL (1)