Recruiting

Leucine

Sponsor:

University of British Columbia

Code:

NCT07437248

Conditions

Pregnancy

Dietary Analysis

Protein

Eligibility Criteria

Sex: Female

Age: 20 - 40

Healthy Volunteers: Accepted

Interventions

Leucine Intake

Study Details

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

Study ID

NCT07437248

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 40

Healthy Volunteers: Accepted

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.)

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Dietary Leucine Requirements

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.

Interventions

Leucine Intake

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.

Primary outcome measure

  • Carbon 13 Oxidation [ Time Frame: 8 Hours ]

Central Contacts and Locations

Central contacts

Layan El Rifai, Graduate Student

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

Locations

BC Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

More Information

Sponsor

University of British Columbia

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Leucine
  • Amino Acid
  • Pregnancy
  • Stable Isotope

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-04-22.