Determining leucine needs during the menstrual cycle
Leucine Requirements During Different Phases of the Menstrual Cycle in Eumenorrheic Women
This study is testing how much leucine, an important nutrient, healthy women aged 20-35 need during different parts of their menstrual cycle to see how it affects their health and protein use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06533501 on ClinicalTrials.gov |
What this trial studies
This study investigates the dietary leucine requirements for healthy women aged 20-35 during different phases of their menstrual cycle. Using a non-invasive method that includes pre-determined diets and breath collection, the study aims to establish how leucine intake affects protein synthesis and overall health. A minimum of 15 participants will be recruited to assess their leucine needs across various intake levels during the follicular and luteal phases. The findings could help refine dietary guidelines specifically for women, addressing the inadequacies of current recommendations based on male physiology.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 20-35 with regular menstrual cycles and a BMI between 18 and 28.
Not a fit: Patients using hormonal birth control or those with abnormal menstrual cycles or certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate dietary guidelines for women, improving their health and nutritional outcomes.
How similar studies have performed: While this approach is innovative, previous studies have successfully used similar methods to investigate amino acid requirements in women, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * People with menstrual cycles * Between the ages of 20 to 35y * Regular menstrual cycle (21-35 day cycle) for the past 12 months * Body mass index (BMI) of between 18 and 28 kg/m2 * Free from pre-existing health conditions Exclusion Criteria: * People who are currently using hormonal birth control or any contraceptive that would affect sex hormones * People on hormone therapy * People with an abnormal menstrual cycle history * People with non-traditional dietary practices * Recent weight loss/weight gain * People with a history of endocrine disorders * People who are pregnant * People who are breastfeeding * People who have given birth in the last 18 months * People who depend on medication that affects normal metabolism. Any medication that alters normal body metabolism would skew the results and compromise the validity of the data set. * People with a metabolic, neurological, genetic, or immune disorder likely to affect nutritional requirements or overall body metabolism.
Where this trial is running
Vancouver, British Columbia
- BC Children's Hospital Research Institute — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Rajavel Elango, PhD
- Email: relango@bcchr.ubc.ca
- Phone: 604-875-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.