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Clinical Trials in Canada / NCT07481201
Recruiting Not applicable

Phenylalanine Requirements in the Menstrual Phases

NCT07481201 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-05-07

Condition(s) studied

Menstrual Cycle

Investigational drug(s) / intervention(s)

Dietary Phenylalanine Intakes

Dietary Phenylalanine Intakes: Participants consume 8 hourly meals that contain the assigned test phenylalanine intake. Each meal will provide one-twelfth of the participants' daily energy requirements as estimated by 1.5 x Resting Energy Expenditure (REE) and adequate protein at 1.0 g.kg.d, to maintain a metabolic steady state. The meals are in the form of a crystalline amino acid protein shake, and protein-free cookies.

Study summary

Phenylalanine is an essential amino acid that must be obtained through food. Current adult phenylalanine recommendation is based on male-conducted studies and set the same for females. These recommendations may not be appropriate for females, as they do not take into consideration the hormonal changes over the menstrual cycle. The menstrual cycle is a rhythmic hormonal process split into two phases, with hormones regulating metabolism differently. The aim of this study is to find phenylalanine requirement for healthy, menstruating females. An innovative, non-invasive technique utilizing pre-determined diets, safe stable isotopes, and a simple breath collection method will be used. Previous work done by Elango Lab investigators has applied this method to investigate other amino acids in pregnant, non-pregnant, and lactating females as well as in children.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
35 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
BC Children's Hospital Research Institute Vancouver British Columbia Recruiting

More University of British Columbia trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07481201 on ClinicalTrials.gov ↗ ← All trials in Canada