NCT06218264

Brief Summary

The present study aims to quantify the insulin sensitivity and the skeletal muscle protein synthetic response to consuming a test drink containing all amino acids or all amino acids except for BCAAs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 10, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

January 11, 2024

Last Update Submit

February 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postprandial muscle protein synthesis

    Muscle protein synthesis rate (FSR) prior to and following ingestion of an amino acid drink

    4 hours

Secondary Outcomes (3)

  • Forearm muscle glucose uptake

    7.5 hours

  • Whole-body insulin sensitivity

    Four hours following ingestion of an amino acid drink

  • Forearm amino acid kinetics

    Prior to and for 4 hours following amino acid intake

Study Arms (2)

FullAA

ACTIVE COMPARATOR

Amino acid drink containing all amino acids

Dietary Supplement: Ingestion of an amino acid supplement

NoBCAA

ACTIVE COMPARATOR

Amino acid drink containing all amino acids except for BCAAs.

Dietary Supplement: Ingestion of an amino acid supplement

Interventions

Oral intake of a supplement containing amino acids

FullAANoBCAA

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged from 18-35 years
  • \< Body mass index \< 30 kg·m2
  • Recreationally active (performing non-competitive physical exercise at least one time per week for minimally 30 minutes)

You may not qualify if:

  • Smoking
  • Diabetes (Type 1, Type 2, or genetic form of diabetes)
  • Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
  • Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
  • Known allergy to lidocaine
  • Regular use of dietary protein and/or amino acid supplements (\>3 times per week)
  • Currently involved in a structured progressive resistance training programme (\>3 times per week)
  • A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia.
  • Any previous motor disorders or disorders in muscle and/or lipid metabolism
  • Presence of an ulcer in the stomach or gut and/or strong history of indigestion
  • Known severe kidney problems
  • Pregnant or breastfeeding
  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6708 WD, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 23, 2024

Study Start

January 10, 2024

Primary Completion

February 13, 2026

Study Completion

February 13, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations