Methionine Intake for Pregnancy

Overseen By Rajavel Elango, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Prenatal vitamins

Must not be taking: Metabolism affecting drugs

Disqualifiers: Multiple pregnancy, Metabolic disorder, Underweight, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the amount of methionine, a key nutrient for building proteins and DNA, that pregnant women need at various pregnancy stages. Researchers use a safe and simple method involving different diets and breath tests. The study targets pregnant women between 11-20 weeks or 31-38 weeks along, who are in good health and not experiencing severe nausea or weight loss during pregnancy.

As an unphased study, this trial allows participants to contribute to important nutritional research that could benefit future pregnancies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes women who depend on medication that affects normal metabolism. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this method is safe for studying methionine intake during pregnancy?

Research shows that methionine, an important nutrient, is vital during pregnancy. It helps build proteins and supports DNA functions in cells. Early studies indicate that the current method of studying methionine in pregnancy is safe and non-invasive. This approach has been safely used to study other nutrients in pregnant women.

However, there is not enough solid information to confirm that methionine is completely safe during pregnancy. Some research suggests that increased methionine intake might reduce the risk of certain birth defects. Yet, having too much or too little methionine in the diet could affect the health of both the mother and the baby.

In summary, methionine appears safe when studied with non-invasive methods during pregnancy, but more research is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Methionine intake is unique because it focuses on the dietary aspect of pregnancy, specifically through the oral consumption of meals enriched with amino acids, which isn't a typical focus of existing prenatal care options. Unlike standard prenatal vitamins and supplements that target a broad range of nutrients, methionine intake specifically aims to optimize amino acid levels, which are critical for fetal development. Researchers are excited about this approach because it represents a targeted nutritional strategy that could enhance pregnancy outcomes by directly influencing maternal and fetal protein metabolism.

What evidence suggests that methionine intake is effective for pregnancy?

Research has shown that methionine, a key nutrient, plays an important role during pregnancy. Studies have found that methionine helps the mother's body accept the growing baby, which is crucial for a healthy pregnancy. It is also needed to build proteins and support DNA, both essential for the baby's development. In early pregnancy, the body uses methionine more quickly, indicating a higher need for it at this time. Overall, evidence supports methionine's importance for a successful pregnancy. Participants in this trial will receive methionine through oral consumption of experimental meals to further study its effects during pregnancy. ^{2 3 6 7 8}

Who Is on the Research Team?

Rajavel Elango, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for healthy women aged 20-40, who are pregnant with one baby and either in their early (11-20 weeks) or late (31-38 weeks) stages of pregnancy. They should not have any pre-existing health conditions.

Inclusion Criteria

I am pregnant with one baby.

I am pregnant and either 11-20 or 31-40 weeks along.

I am in good health with no pre-existing conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Pre-study Assessment

Participants undergo pre-study assessments including measurements of height, weight, bioelectrical impedance analysis, skinfold, blood glucose, and resting energy expenditure

1 hour

1 visit (in-person)

Study Day

Participants receive eight hourly meals with varying methionine intakes and undergo biological sample collection and analysis

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study day

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Methionine

Trial Overview The study is determining the necessary intake of methionine, an essential amino acid, during different stages of pregnancy using a safe and non-invasive method involving diet variation, stable isotopes, and breath collection.

How Is the Trial Designed?

Group I: Methionine Intake Experimental Treatment 1 Intervention

Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.

Methionine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Methionine for:

• Nutritional supplement in parenteral nutrition

Approved in United States as Methionine for:

• Nutritional supplement in parenteral nutrition

Approved in Canada as Methionine for:

• Nutritional supplement in parenteral nutrition

Approved in Japan as Methionine for:

• Nutritional supplement in parenteral nutrition

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2806892/

Methionine metabolism in human pregnancy1 - PMC The fractional rate and total rate of transsulfuration of methionine was significantly (P < 0.05) higher during the first trimester, whereas the rate of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211124725000622

Methionine regulates maternal-fetal immune tolerance and ... Here, we showed that maternal methionine supply significantly improved pregnancy outcomes, which was closely related to interleukin-5 (IL-5) ...

3. cell.com cell.com/cell-reports/pdf/S2211-1247(25)00062-2.pdf

Methionine regulates maternal-fetal immune tolerance and ... Here, we showed that maternal methionine supply significantly improved pregnancy outcomes, which was closely related to interleukin-5 (IL-5) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04326322

Methionine Requirements During Healthy Human Pregnancy The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

5. fertstert.org fertstert.org/article/S0015-0282(16)42563-X/pdf

Effect of Excess Dietary Methionine on Rat Pregnancy The addition of 4% dl-methionine to a diet of 18% or 12% casein reduced pregnancy maintenance in the rat from 100% to 48% and 5%, respectively. Fetal weight.

6. webmd.com webmd.com/vitamins/ai/ingredientmono-42/methionine

Methionine - Uses, Side Effects, and More Eating more methionine during pregnancy seems to lower the risk of these birth defects. ... There isn't enough reliable information to know if methionine is safe ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622083109

Sulfur Amino Acid Metabolism in Pregnancy: The Impact of ... Diets with an inappropriate balance of methionine can adversely affect both short-term reproductive function and the long-term physiology of the offspring.

8. whri.org whri.org/methionine-requirements-during-healthy-human-pregnancy/

Methionine Requirements during Healthy Human Pregnancy A study to find the optimal amount of methionine (protein) needed from the diet during human pregnancy.