Validating IAAO for Muscle Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Consuming dietary protein stimulates whole-body and muscle protein synthesis, the latter of which is typically measured using invasive primed constant infusions of stable isotopes with concurrent muscle biopsies. Alternative non-invasive methodologies have been developed (namely the indicator amino acid oxidation (IAAO) technique) to estimate the impact of protein ingestion on whole-body protein synthesis as a proxy for determining dietary protein requirements. Given that the IAAO technique is based on principles of protein metabolism which occur in the liver, it is unclear how representative the IAAO outcomes of whole-body protein synthesis is to skeletal muscle protein synthesis. Validation of the IAAO technique against gold-standard, biopsy-derived measures of muscle metabolism (i.e., muscle protein synthesis) would assist in mitigating the invasiveness of muscle physiology and nutrition research.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Habitual Protein Intake on AA Tracer Oxidation

NCT03845569

Protein/Amino Acid Metabolism Indicator Amino Acid Oxidation Method

COMPLETED NA

Protein Requirements in Resistance-trained Males

NCT03696264

Healthy

COMPLETED NA

Protein Requirements in Resistance Trained Females

NCT03397043

Healthy

COMPLETED NA

Measuring Protein Requirement Using Amino Acid Oxidation in Strength and Endurance Athletes

NCT02621294

Protein Requirement of Athletes

UNKNOWN NA

Indicator Amino Acid Oxidation in ICU Patients

NCT06104527

Critical Illness Muscle Wasting

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Protein Metabolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group:

Eight healthy young (18-35 years, 4 females and 4 males) will be subjected to 2 skeletal muscle biopsies, collection of blood and urine samples, and a non-invasive 13CO2 breath-test over a 6.5-hour period while ingesting half-hourly protein beverages with stable isotope tracers. The breath-test is based on the indicator amino acid oxidation (IAAO) method.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Protein + Stable Isotope Tracer Beverage

Participants will consume 12 half-hourly (6 hours) isoenergetic, isonitrogenous beverages containing 0.9g/kg fat-free mass/day protein. Drinks will be enriched with stable isotopes \[2H5\]Phenylalanine and \[1-13C\]Phenylalanine, which will respectively allow for determination of muscle protein synthesis and whole-body protein synthesis over the subsequent 6 hours of feeding.

Group Type EXPERIMENTAL

Protein + Stable Isotope Tracer Beverage

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 12 half-hourly (6 hours) isoenergetic, isonitrogenous beverages containing 0.9g/kg fat-free mass/day protein. Drinks will be enriched with stable isotopes \[2H5\]Phenylalanine and \[1-13C\]Phenylalanine, which will respectively allow for determination of muscle protein synthesis and whole-body protein synthesis over the subsequent 6 hours of feeding

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Protein + Stable Isotope Tracer Beverage

Participants will consume 12 half-hourly (6 hours) isoenergetic, isonitrogenous beverages containing 0.9g/kg fat-free mass/day protein. Drinks will be enriched with stable isotopes \[2H5\]Phenylalanine and \[1-13C\]Phenylalanine, which will respectively allow for determination of muscle protein synthesis and whole-body protein synthesis over the subsequent 6 hours of feeding

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants will be aged 18-35 years old
* Participants will have a BMI within the normal range (i.e., 18.5-24.9) and waist-to-hip circumference ratio of \<0.95 for males and \<0.8 for circumference for females to ensure homogeneity of the sample population
* Participants are willing to abide by the compliance rules of this study (e.g., abstain from extraneous physical activity 48h prior to session 4
* Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants)
* Physical activity score of ≥24 units as measured by the Godin leisure time exercise questionnaire

Exclusion Criteria

* Inability to adhere to any of the compliance rules judged by principal investigator
* Self-reported regular tobacco or illicit drug use (e.g., growth hormone or testosterone)
* Current use of hormonal contraceptives
* Individuals with a history of allergy to local anesthetics (e.g., lidocaine)

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes