HealthyNCT05394155
Leucine Requirement in Adult Men and Women
A study testing Leucine in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Leucine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 29 Apr 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Leucine Requirement in Young Men and Women Using the Indicator Amino Acid Oxidation (IAAO) Method
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.
Read the 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 will be weighed at the pre-study assessment and at the start of each IAAO study day to ensure accurate prescription of diets and isotopes, and to confirm weight maintenance throughout the study.
Each study will consist of a 2-day adaptation period to a prescribed diet in accordance with the energy requirement of the subject and 1-study day. The diet will provide an adequate amount of protein, of 1 g protein∙kg-1∙d-1. The 2-day adaptation period is to allow the body to adapt to an adequate amount of protein as it has been shown that protein kinetics is altered without it. Following the 2 days of adaptation is the study day where leucine intake will be randomly assigned and phenylalanine (Phe) kinetics will be measured with the use of L-[1-13C]phenylalanine. On this day, VCO2 will be measured by calorimetry immediately after the 5th meal for a period of 20 minutes, and a 15ml blood sample will be collected at the end of each study visit to measure plasma amino acid levels, insulin, and glucose in males and females and progesterone, and estrogen in females.
For female participants, each level of intake will be studied both in the luteal and follicular phase of their menstrual cycle (up to 14 studies in total). For the follicular phase, the study will be conducted 3-7 days immediately after the 1st day of menstrual bleeding. For the luteal phase, the study will be conducted 4-7 days before the onset of next menstrual bleeding. The IAAO study day of the luteal phase will be set on the basis of each subject's length of their menstrual cycle, and the length and regularity of their cycle will be determined during the pre-study assessment.
- Conditions
- Healthy
- Being tested
- Leucine
- Keywords
- Leucine, amino acid, nutrition, requirement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucineDietary supplement
7 intake levels of leucine, ranging from 10 to 75 mg/kg/d.
| Study group | Role | What they receive |
|---|---|---|
| Leucine intake | Experimental | 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. Receives: Dietary Supplement: Leucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
F13CO2
Rate of appearance of labelled carbon dioxide (13CO2) in breath from the oxidation of 13C-Phenylalanine
Measured: 4.5 hours during study visits
Secondary outcomes (2)
13C-phenylalanine enrichment
urinary 13C-phenylalanine enrichment
Measured: 4.5 hours during study visits
Plasma amino acid concentrations
To assess the effect of amino amino acid intake on plasma amino acid concentration.
Measured: at end of each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start29 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures study design.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, PhD, RD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394155
- Sponsor's protocol ID
- 1000078896
- Status last verified
- Feb 2024
- First submitted
- 19 May 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szwiega S, Pencharz PB, Xu L, Kong D, Tomlinson C, Elango R, Courtney-Martin G. Leucine requirement determined in healthy young adult males using the indicator amino acid oxidation method. Am J Clin Nutr. 2024 Nov;120(5):1063-1070. doi: 10.1016/j.ajcnut.2024.08.022. Epub 2024 Aug 28.
PubMed 39209155
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Leucine Requirement in Young Men and Women Using the Indicator Amino Acid Oxidation (IAAO) Method
- ClinicalTrials.gov ID
- NCT05394155
- Acronym / sponsor ID
- 1000078896
- Conditions
- Healthy
- Keywords
- Leucine, amino acid, nutrition, requirement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 will be weighed at the pre-study assessment and at the start of each IAAO study day to ensure accurate prescription of diets and isotopes, and to confirm weight maintenance throughout the study.
Each study will consist of a 2-day adaptation period to a prescribed diet in accordance with the energy requirement of the subject and 1-study day. The diet will provide an adequate amount of protein, of 1 g protein∙kg-1∙d-1. The 2-day adaptation period is to allow the body to adapt to an adequate amount of protein as it has been shown that protein kinetics is altered without it. Following the 2 days of adaptation is the study day where leucine intake will be randomly assigned and phenylalanine (Phe) kinetics will be measured with the use of L-[1-13C]phenylalanine. On this day, VCO2 will be measured by calorimetry immediately after the 5th meal for a period of 20 minutes, and a 15ml blood sample will be collected at the end of each study visit to measure plasma amino acid levels, insulin, and glucose in males and females and progesterone, and estrogen in females.
For female participants, each level of intake will be studied both in the luteal and follicular phase of their menstrual cycle (up to 14 studies in total). For the follicular phase, the study will be conducted 3-7 days immediately after the 1st day of menstrual bleeding. For the luteal phase, the study will be conducted 4-7 days before the onset of next menstrual bleeding. The IAAO study day of the luteal phase will be set on the basis of each subject's length of their menstrual cycle, and the length and regularity of their cycle will be determined during the pre-study assessment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures study design.
| Arm | Type | Receives |
|---|---|---|
| Leucine intake | Experimental | Dietary Supplement: LeucineFor 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leucine7 intake levels of leucine, ranging from 10 to 75 mg/kg/d. | Dietary supplement | Leucine intake |
Primary outcome
F13CO2
Time frame: 4.5 hours during study visits
Rate of appearance of labelled carbon dioxide (13CO2) in breath from the oxidation of 13C-Phenylalanine
2 secondary outcomes
13C-phenylalanine enrichment
Time frame: 4.5 hours during study visits
Plasma amino acid concentrations
Time frame: at end of each study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 39209155Szwiega S, Pencharz PB, Xu L, Kong D, Tomlinson C, Elango R, Courtney-Martin G. Leucine requirement determined in healthy young adult males using the indicator amino acid oxidation method. Am J Clin Nutr. 2024 Nov;120(5):1063-1070. doi: 10.1016/j.ajcnut.2024.08.022. Epub 2024 Aug 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenda Courtney-Martin, PhD, RD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F13CO2 (time frame: 4.5 hours during study visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.