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Active, not recruitingNCT07317921ClinicalTrials.gov record

Validating IAAO for Muscle Outcomes

Protein Metabolism

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 35 years
Sex eligible
All sexes
Healthy volunteers
Accepted
Participants
8 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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)
Understand screening

Treatment, groups and participation

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Assignment
Not applicable
Masking
No masking
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.

Dietary Supplement: Protein + Stable Isotope Tracer Beverage

Protein + Stable Isotope Tracer Beverage 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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Phenylalanine excretion (umol/kg/h)

Time frame: 6.5 hours

Rate of whole-body phenylalanine excretion following orally ingested amino acid tracer \[1-13C\]Phenylalanine determined from the product of breath 13CO2 enrichment and carbon dioxide production rate (VCO2).

Phenylalanine oxidation (umol/kg/h)

Time frame: 6.5 hours

Rate of whole-body phenylalanine oxidation following orally ingested amino acid tracer \[1-13C\]Phenylalanine determined from the correction of phenylalanine excretion by the phenylalanine precursor enrichment via urine enrichment.

Myofibrillar protein synthesis (%/hr)

Time frame: 6.5 hours

Rate of myofibrillar fractional synthesis is determined by rate of incorporation of orally ingested tracer \[2H5\]Phenylalanine into myofibrillar proteins (isolated from skeletal muscle biopsies) and the enrichment of \[2H5\]Phenylalanine in plasma collected over the 6 hours protein consumption period. Enrichment will be quantified via tandem LC-MS/MS to derive a rate of incorporation over the 6-hour period.

Sarcoplasmic protein synthesis (%/hr)

Time frame: 6.5 hours

Rate of sarcoplasmic fractional synthesis is determined by rate incorporation of orally ingested tracer \[2H5\]Phenylalanine into sarcoplasmic (ie., soluble) proteins (isolated from skeletal muscle biopsies) and the enrichment of \[2H5\]Phenylalanine in plasma collected over the 6 hours protein consumption period. Enrichment will be quantified via tandem LC-MS/MS to derive a rate of incorporation over the 6-hour period.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

Kinesiology & Physical EducationToronto, Ontario, CanadaStatus unknown

Study team and timeline

Lead sponsor
University of Toronto
Study start
Dec 1, 2025 Actual
Primary completion
Apr 17, 2026 Actual
Study completion
Dec 20, 2026 Estimated
First posted
Jan 5, 2026 Actual
Last updated
Nov 9, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Validating the Indicator Amino Acid Oxidation Technique for Muscle Outcomes

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026