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Amino Acid

Leucine Requirements for Healthy Adults

N/A
Waitlist Available
Led By Glenda Courtney-Martin, PhD, RD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy adult males, 18 to 39 years of age
Healthy adult females, 18 to 39 years of age with regular menstrual cycles within the last 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of each study visit
Awards & highlights

Study Summary

This trial will help determine the necessary amount of the amino acid leucine for adults aged 18-39.

Who is the study for?
This trial is for healthy non-smoking adults aged 18-39 with a BMI of 18.5-27, who haven't lost significant weight recently. Men and women can join; women must have regular menstrual cycles. Participants should not have chronic diseases like diabetes or cancer, nor take medications affecting protein metabolism.Check my eligibility
What is being tested?
The study aims to determine the necessary intake of leucine, an essential amino acid, in young adult men and women. It involves consuming diets provided by the researchers and undergoing assessments such as blood tests and metabolic measurements.See study design
What are the potential side effects?
Since this trial involves nutritional assessment rather than drug testing, side effects are minimal but may include discomfort from blood draws or dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy man aged between 18 and 39.
Select...
I am a healthy woman, aged 18-39, with regular periods in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 hours during study visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 hours during study visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
F13CO2
Secondary outcome measures
13C-phenylalanine enrichment
Plasma amino acid concentrations

Trial Design

1Treatment groups
Experimental Treatment
Group I: Leucine intakeExperimental Treatment1 Intervention
For this study, each participant will be randomly assigned to receive up to 7 intake levels of leucine, ranging from 10 to 75 mg/kg/d.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucine
2011
Completed Phase 3
~540

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
682 Previous Clinical Trials
6,945,302 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,333 Previous Clinical Trials
25,747,326 Total Patients Enrolled
Glenda Courtney-Martin, PhD, RDPrincipal InvestigatorThe Hospital for Sick Children
4 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

Leucine (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT05394155 — N/A
Healthy Subjects Research Study Groups: Leucine intake
Healthy Subjects Clinical Trial 2023: Leucine Highlights & Side Effects. Trial Name: NCT05394155 — N/A
Leucine (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05394155 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will I be eligible to partake in this investigation?

"To be eligible for this research, potential participants need to possess healthy specimens and lie within the age range of 18-39. A total of 32 individuals will take part in the experiment."

Answered by AI

What is the scope of participants receiving treatment in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting participants with an initial posting date of April 29th 2022 and most recent update on May 23rd 2022. 32 individuals are required at a single site for the study's completion."

Answered by AI

Are physicians allowing individuals aged 35 or older to join the trial?

"This research is seeking participants aged between 18 and 39 years old."

Answered by AI

Is this scientific experiment currently accepting participants?

"Affirmative. Data visible on clinicaltrials.gov confirms that this experiment, which was first advertised on April 29th 2022, is still open for recruitment and requires 32 individuals from a single centre to participate in the trial."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What site did they apply to?
The Hospital for Sick Children
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~11 spots leftby Mar 2025