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

69 Participants Needed

Trial Summary

What is the purpose of this trial?

The current recommendations for dietary amino acid intake in pregnant women are based on calculations from requirements of adult men. The study aims to determine methionine requirements during early (11-20 weeks) and late (31-38 weeks) stages of pregnancy. Methionine, an essential amino acid (building block of body protein), is necessary for protein synthesis and for DNA related cellular functions. A non-invasive, novel method based on different diets, stable isotopes (the safe kind) and simple breath collection will be used. This method has recently been used by our laboratory to study other amino acids during pregnancy.

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 data supports the effectiveness of the treatment Methionine, DL-Methionine, L-Methionine for pregnancy?

Research in mice suggests that a form of methionine, called methionyl-methionine, can improve pregnancy outcomes by enhancing embryo development and birth weight. This is achieved by increasing nutrient availability and activating certain biological pathways that support growth. ^{1 2 3 4 5}

Is methionine safe for use during pregnancy?

Research on methionine in pregnancy, mostly in mice, suggests it may affect fetal development and maternal health, but its safety in humans is not well-established. Some studies indicate potential impacts on offspring's body weight and activity levels, but more human research is needed to confirm safety. ^{1 2 6 7 8}

How does the drug Methionine differ from other treatments for pregnancy-related conditions?

Methionine is unique because it is an amino acid that can influence pregnancy outcomes by affecting ovarian function and fetal development. Unlike other treatments, it can impact the methionine cycle and methylation processes, which are crucial for fetal growth and development, and may also enhance lactation performance when delivered as a dipeptide. ^{1 4 7 9 10}

Research Team

Rajavel Elango, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Parenterally Delivered Methionyl-Methionine Dipeptide During Pregnancy Enhances Mammogenesis and Lactation Performance Over Free Methionine by Activating PI3K-AKT Signaling in Methionine-Deficient Mice. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Methionine Partially Replaced by Methionyl-Methionine Dipeptide Improves Reproductive Performance over Methionine Alone in Methionine-Deficient Mice. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of maternal multiple micronutrient supplements on cord blood hormones: a randomized controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Combined Vitamin B-12 and Balanced Protein-Energy Supplementation Affect Homocysteine Remethylation in the Methionine Cycle in Pregnant South Indian Women of Low Vitamin B-12 Status. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Sulfur amino acid metabolism in pregnancy: the impact of methionine in the maternal diet. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Methionine metabolism in human pregnancy. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Maternal methionine supplementation in mice affects long-term body weight and locomotor activity of adult female offspring. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Homocysteine, red cell, and plasma folate concentrations and birth weight in Italian women: results from a prospective study. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of excess dietary methionine on rat pregnancy: influence on ovarian delta5-3beta-hydroxysteroid dehydrogenase activity. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Effects of different levels of methionine on sow health and plasma metabolomics during late gestation. [2019]