Status:
COMPLETED
Leucine Requirement in Adult Men and Women
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Healthy
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
The purpose of the study is to determine the body's nutritional need for the essential amino acid, leucine, in adult men and women 18 to 39 years of age.
Detailed Description
The experimental design will be based on the minimally invasive IAAO model (12). Each participant will be studied at a minimum of 4 and up to 7, randomly assigned, intake levels of leucine. Subjects ...
Eligibility Criteria
Inclusion
- Healthy adult males, 18 to 39 years of age.
- Healthy adult females, 18 to 39 years of age with regular menstrual cycles within in the last 12 months.
- Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire).
- No recent history of weight loss
- BMI between 18.5 - 27 kg/m 2
- Absence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, COVID-19, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
- Non-smoking
- Willingness to consume the diet provided.
Exclusion
- Presence of disease known to affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, Covid-19, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
- On medications known to affect protein and amino acid metabolism (steroids) or taking oral contraceptive pills or other birth control devices that would affect sex hormone profiles over the last 2 years.
- Pregnant or lactating women.
- Recent significant weight loss; ≥ 5% of body with in the last 3 months.
- Individuals on weight reducing diets.
- Inability to tolerate the diet
- Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
- Significant coffee consumption of more than 2 cups/day
- Significant alcohol consumption of more than one drink/day
- Failure to disclose any of the information needed to assess eligibility.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05394155
Start Date
April 29 2022
End Date
December 31 2023
Last Update
February 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8