- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972582
Upper Limit of Leucine Intake in Adults
Determination of the Tolerable Upper Limit of Leucine Intake in Adult Humans
Study Overview
Detailed Description
The objective of the study will be to determine the 'metabolic limit' of leucine oxidation in healthy young men by:
A) Measuring leucine oxidation in response to short term (8 hr) graded excess leucine intake B) Correlating changes in leucine oxidation with changes in plasma concentrations of keto-isocaproic acid (KIC, the first breakdown product of leucine metabolism), other essential amino acids, ammonia, urea, creatinine, glucose, insulin, and electrolytes (sodium, potassium, chloride) to identify potential biomarkers C) Correlating changes in leucine oxidation with changes in urinary excretion of leucine and ketoisocaproic acid (KIC), urea and creatinine to identify potential biomarkers
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- 18-35 years old
Exclusion Criteria:
- Report a recent history of sudden weight loss
- Have unusual dietary habits such as chronic consumption of caffeinated beverages or alcohol
- Have any endocrine disorders
- Are currently using any prescribed medications
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Leucine
|
Graded stepwise increases in leucine intakes (50, 250, 500, 750, 1000, 1250 and 1500mg/kg/day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Breath carbon dioxide production
Time Frame: Study Visits 1-7 (-45min,-30min,-15min, +2.5hrs, +3hrs, +3.5Hrs +4hrs)
|
Study Visits 1-7 (-45min,-30min,-15min, +2.5hrs, +3hrs, +3.5Hrs +4hrs)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma
Time Frame: Study Visits 1-7 (Hourly)
|
Study Visits 1-7 (Hourly)
|
Urine
Time Frame: Study Visits 1-7 (8hr timepoint)
|
Study Visits 1-7 (8hr timepoint)
|
VCO2
Time Frame: Study Visits 1-7 (after 5hr meal)
|
Study Visits 1-7 (after 5hr meal)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul B Pencharz, MD, The Hospital for Sick Children, Toronto, Canada
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1000012066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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