40 Participants NeededMy employer runs this trial

Leucine Intake for Pregnancy

LE
Overseen ByLayan El Rifai, Graduate Student
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the leucine requirements of pregnant women at various stages, focusing on this essential amino acid's role in muscle and growth. Participants will consume specially prepared meals and provide samples to help researchers understand how the body metabolizes leucine. The trial aims to refine nutrition guidelines for pregnant women, promoting healthier pregnancies and babies. Ideal participants are healthy pregnant women carrying one baby, between 11-20 weeks or 31-40 weeks of gestation, with a pre-pregnancy body mass index (BMI) between 19 and 28. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance nutritional recommendations for pregnant women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your healthcare provider.

What prior data suggests that leucine intake is safe for pregnant women?

Research has shown that taking leucine, a necessary nutrient, during pregnancy is generally safe. One study found that even high doses of leucine did not negatively affect pregnancy, indicating it is well-tolerated when taken orally. Leucine is important for muscle health and supports the baby's growth, making it a vital part of nutrition during pregnancy. Overall, leucine has been shown to be safe for pregnant women.12345

Why are researchers excited about this trial?

Unlike the standard of care for pregnancy nutrition, which typically involves general dietary recommendations and prenatal supplements, the use of leucine in this trial is unique because it directly targets protein metabolism. Leucine is an essential amino acid that plays a crucial role in muscle protein synthesis, offering a potentially more precise way to support maternal and fetal health during pregnancy. Researchers are excited about this treatment because it could optimize nutritional intake in a very targeted manner, possibly enhancing pregnancy outcomes in ways that standard prenatal nutrition has not yet achieved.

What evidence suggests that leucine intake is effective for supporting maternal health and fetal development during pregnancy?

Research has shown that leucine, a key nutrient, plays a crucial role in muscle health and fetal growth during pregnancy. This trial will provide participants with varying levels of leucine intake to assess its effects. Leucine supplements can aid in fetal growth when growth issues arise. Studies have found that leucine can be safely used during pregnancy without negative effects. Additionally, leucine helps improve overall health by reducing body fat and managing blood sugar levels. Overall, leucine supports a healthy pregnancy.26789

Are You a Good Fit for This Trial?

This trial is for healthy pregnant women aged 20-40, between 11-20 or 31-40 weeks of pregnancy, with a single baby and no major health issues or pregnancy complications. Participants must have a pre-pregnancy BMI between 19 and 28 and not use alcohol, tobacco, or drugs during pregnancy.

Inclusion Criteria

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
I am pregnant and between 20 and 40 years old.
See 5 more

Exclusion Criteria

Multiple gestation pregnancies
Pregnancy-related complications (e.g., hyperemesis gravidarum, GDM, hypertension, pre-eclampsia, anemia)
History of adverse pregnancy outcomes (spontaneous abortion or preterm birth)
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Early Gestation Treatment

Participants consume randomized, graded intakes of dietary leucine during early gestation (11-20 weeks) to assess leucine requirements using the IAAO method.

9 weeks
Multiple study days (in-person)

Late Gestation Treatment

Participants consume randomized, graded intakes of dietary leucine during late gestation (31-40 weeks) to assess leucine requirements using the IAAO method.

9 weeks
Multiple study days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Leucine

Trial Overview

Researchers are studying how much leucine (an important protein building block) pregnant women need at different stages by providing special meals and collecting breath, urine, and blood samples to see how the body uses leucine.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dietary Leucine RequirementsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Citations

Dietary Supplementation of Leucine in Premating Diet ... - PMC

Leucine supplementation in premating diet could improve the reproductive performance, which could be attributed to the improved oxidative and immune status.

NCT07437248 | Leucine Requirements During Pregnancy

Leucine plays an important role in supporting muscle health and fetal growth. Participants will consume carefully prepared meals and provide breath, urine ...

Prolonged oral treatment with an essential amino acid l- ...

These results suggested that l-leucine, administered orally during organogenesis at doses up to 1000 mg/kg body weight, did not affect the outcome of pregnancy ...

Prolonged oral treatment with an essential amino acid L ...

These results suggested that L-leucine, administered orally during organogenesis at doses up to 1000 mg/kg body weight, did not affect the outcome of pregnancy ...

L-Leucine Improves Metabolic Disorders in Mice With in- ...

Conclusions: Postnatal L-leucine supplement could reduce fat accumulation and ameliorate glucose metabolic disorder caused by maternal SE. The ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/15234081/

Prolonged oral treatment with an essential amino acid L- ...

These results suggested that L-leucine, administered orally during organogenesis at doses up to 1000 mg/kg body weight, did not affect the outcome of pregnancy ...

L-Leucine Supplementation May Be Safe During Pregnancy

Theresearchers concluded L-leucine, administered orally during organogenesis atdoses up to 1,000 mg/kg body weight, did not affect the outcome of pregnancy ...

Leucine Is Essential for Attenuating Fetal Growth ...

We investigated the role of Leu in combination with other BCAA on effects that are induced by maternal protein restriction on fetal growth.

Leucine supplementation in maternal high-fat diet alleviated ...

The present study investigated the effects of maternal leucine consumption before mating, during pregnancy, and during lactation on long-term HF ...