Overseen ByRajavel Elango, PhD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of British Columbia
No Placebo Group
Approved in 4 jurisdictions
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.
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.
+1 more
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Methionine IntakeExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BC Children's Hospital Research InstituteVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor