Leucine Requirements During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorUniversity of British Columbia
About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Participants who take part in early gestation, can participate in late gestation, if they meet all inclusion criteria.
Disqualifiers
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.)
Trial design
Design model
Single group
Treatments tested in this trial
Leucine Intake
Dietary supplementEach 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Dietary Leucine RequirementsExperimental treatment 1 intervention
Trial outcomes
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
Time frame
8 HoursSponsors and contacts
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University of British Columbia
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov