| NCT ID | NCT07437248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-04-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to understand how much leucine, an essential amino acid, and protein building block, healthy pregnant women need during early and late pregnancy. Leucine plays an important role in supporting muscle health and fetal growth. Participants will consume carefully prepared meals and provide breath, urine samples, and one blood sample so researchers can measure how the body uses leucine at different stages of pregnancy. The results will help improve nutrition guidelines for pregnant women to better support maternal health and healthy fetal development.
Eligibility Criteria
Inclusion Criteria: * Pregnant women aged 20-40 years. (This age range represents typical reproductive age and minimizes potential confounding effects related to adolescent growth or age-associated metabolic changes.) * Singleton pregnancy. (Restricting participation to singleton pregnancies reduces variability in nutrient requirements and metabolic demands associated with multiple gestations.) * Gestational age of either 11-20 weeks (early gestation) or 31-40 weeks (late gestation). (These time points represent physiologically distinct stages of pregnancy, allowing comparison of leucine requirements across early and late gestation.) * Participants who take part in early gestation, can participate in late gestation, if they meet all inclusion criteria. * Good general health with no acute or chronic medical conditions. (Including only healthy participants minimizes confounding factors that could alter amino acid metabolism and ensures participant safety.) * Fully ambulatory and able to comply with study procedures. (Participants must be able to attend study visits and complete protocol requirements, including dietary intake and sample collection.) * Pre-pregnancy body mass index (BMI) between 19 and 28 kg/m² (This range excludes underweight and obese individuals, whose altered protein and amino acid metabolism could affect study outcomes.) * Carrying a viable pregnancy without known complications at enrollment. (Excluding pregnancy complications at baseline reduces risk to participants and supports accurate assessment of physiological amino acid requirements.) Exclusion Criteria: -Pregnancy-related complications (e.g., hyperemesis gravidarum, GDM, hypertension, pre-eclampsia, anemia). (These conditions may alter metabolism and increase risk, potentially confounding study outcomes.) * History of adverse pregnancy outcomes (spontaneous abortion or preterm birth). (May reflect underlying physiological factors affecting amino acid metabolism.) * Multiple gestation pregnancies. (Nutritional and metabolic demands differ from singleton pregnancies.) * Pregnancy loss within six months of the current pregnancy. (Short intervals may affect maternal nutrient status and metabolic adaptation.) * Chronic metabolic, cardiovascular, neurological, genetic, or immune disorders. (These conditions may independently affect protein and amino acid metabolism.) * Clinically significant claustrophobia. (May interfere with study procedures requiring ventilated hood measurements.) * Use of alcohol, tobacco, or illicit substances during pregnancy. (Substance use affects metabolism and poses maternal and fetal health risks.) * Gestational weight loss greater than 1.5 kg. (May indicate inadequate nutritional status.) * Pre-pregnancy BMI outside 19-28 kg/m². (Extremes of BMI are associated with altered protein metabolism.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07437248 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07437248 currently recruiting?
Yes, NCT07437248 is actively recruiting participants. Contact the research team at layan.el-rifai@bcchr.ca for enrollment information.
Where is the NCT07437248 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT07437248 clinical trial?
NCT07437248 is sponsored by University of British Columbia. The trial plans to enroll 40 participants.