Leucine Requirements During Pregnancy

Recruiting now · Not applicable

Conditions studied: Pregnancy, Dietary Analysis, Protein

In brief

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.

Key facts

Study ID

NCT07437248

Run by

University of British Columbia

People needed

40

Starts

2026-04-01

Expected to finish

2027-12-01

Last updated by the study team

2026-04-22

Who can join

Age: 20 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.)

Where it is running

• BC Children's Hospital Research Institute — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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