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New treatment option for Pregnancy
Official title Leucine Requirements During Pregnancy
ClinicalTrials.gov ID: NCT07437248
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant women aged 20-40 years. (This age range represents typical reproductive age and minimizes potential confounding effects related to...
- Singleton pregnancy. (Restricting participation to singleton pregnancies reduces variability in nutrient requirements and metabolic demands...
- Gestational age of either 11-20 weeks (early gestation) or 31-40 weeks (late gestation). (These time points represent physiologically distinct stages...
- Participants who take part in early gestation, can participate in late gestation, if they meet all .
- Good general health with no acute or chronic medical conditions. (Including only healthy participants minimizes confounding factors that could alter...
You likely can't join if
- -Pregnancy-related complications (e.g., hyperemesis gravidarum, GDM, hypertension, pre-eclampsia, anemia). (These conditions may alter metabolism and...
- History of adverse pregnancy outcomes (spontaneous abortion or preterm birth). (May reflect underlying physiological factors affecting amino acid...
- 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...
- Clinically significant claustrophobia. (May interfere with study procedures requiring ventilated hood measurements.)
See the full eligibility 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...
- Participants who take part in early gestation, can participate in late gestation, if they meet all .
- 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...
- -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.)
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.