Leucine Requirements During Pregnancy

NCT07437248 | Not Yet Recruiting

• 1 other identifier: H25-04088
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Dietary Analysis; Protein

Keywords

Leucine; Amino Acid; Pregnancy; Stable Isotope

Outcome Measures

Primary Outcomes (1)

• Carbon 13 Oxidation

  Urine and breath samples will be collected to measure the rate of oxidation of L-\[1-13C\]phenylalanine oxidation

  8 Hours

Study Arms (1)

Dietary Leucine Requirements

EXPERIMENTAL

Randomly assign the participant to receive a test leucine oral intake (ranging between 20 to 100 mg.kg.d) as an 8-hourly isocaloric and isonitrogenous meal that consist of a liquid formula shake and protein-free cookies.

Dietary Supplement: Leucine Intake

Interventions

Leucine Intake DIETARY_SUPPLEMENT

Each hourly meal will provide one-twelfth of the participants' daily energy requirements as estimated by 1.7 Resting Energy Expenditure and adequate protein (at 1.5 g.kg.d), to maintain a metabolic steady state. The liquid shake contains protein-free powder orange-flavored drink crystals, corn oil, and water.

Dietary Leucine Requirements

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Cis-women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.)
• 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.)

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Central Study Contacts

Layan El Rifai, Graduate Student

CONTACT

+1 672 380 9384; layan.el-rifai@bcchr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)