Folic Acid Supplementation in Women of Child Bearing Age
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | May 2016 |
Effect of Obesity and Folic Acid Supplementation on Gene-specific DNA Methylation in Women of Reproductive Age
The objective of this study is to identify genes whose expression is potentially modifiable
due to changes in folate intake and help delineate mechanisms accounting for the variability
in individual response to folic acid supplementation. The study will be conducted in normal
weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic
acid.
It is hypothesized that (1) a change in folate status, induced by the supplementation, will
influence the DNA methylation of specific genes and (2) the DNA methylation response to
folic acid supplementation may differ between the normal weight and the obese women of
childbearing age.
due to changes in folate intake and help delineate mechanisms accounting for the variability
in individual response to folic acid supplementation. The study will be conducted in normal
weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic
acid.
It is hypothesized that (1) a change in folate status, induced by the supplementation, will
influence the DNA methylation of specific genes and (2) the DNA methylation response to
folic acid supplementation may differ between the normal weight and the obese women of
childbearing age.
This study will be conducted in two phases. An initial screening study will be performed to
determine folate status, MTHFR677 genotype and body composition of potential participants of
the intervention study. Both folate status and MTHFR677 genotype are known independent
predictors of response to folic acid supplementation. Blood samples will be collected, after
an overnight fast, for determination of serum folate concentration and for MTHFR677
genotyping. Body composition and 24-hr dietary recalls will also be conducted during the
screening visit.
The second phase is an eight week supplementation trial with 800 mcg/day folic acid.
Screened individuals determined to have a serum folate < 30 nmol/L (< 50th percentile of
NHANES 1999-2004) and of the CC or CT genotype (for MTHFR677) will be eligible for inclusion
in the supplementation trial. Participants will be instructed to avoid dietary supplements,
fortified ready-to-eat cereals, and other high folate content foods during intervention.
Blood samples will be collected, after an overnight fast, at baseline and after 4 and 8
weeks of supplementation for determination of primary (DNA methylation profile) and
secondary (nutritional, metabolic and health status biomarkers) outcome measures.
determine folate status, MTHFR677 genotype and body composition of potential participants of
the intervention study. Both folate status and MTHFR677 genotype are known independent
predictors of response to folic acid supplementation. Blood samples will be collected, after
an overnight fast, for determination of serum folate concentration and for MTHFR677
genotyping. Body composition and 24-hr dietary recalls will also be conducted during the
screening visit.
The second phase is an eight week supplementation trial with 800 mcg/day folic acid.
Screened individuals determined to have a serum folate < 30 nmol/L (< 50th percentile of
NHANES 1999-2004) and of the CC or CT genotype (for MTHFR677) will be eligible for inclusion
in the supplementation trial. Participants will be instructed to avoid dietary supplements,
fortified ready-to-eat cereals, and other high folate content foods during intervention.
Blood samples will be collected, after an overnight fast, at baseline and after 4 and 8
weeks of supplementation for determination of primary (DNA methylation profile) and
secondary (nutritional, metabolic and health status biomarkers) outcome measures.
Inclusion Criteria:
- Screening Phase:
- Female 18-40 yr
- Body Mass index 18.5 to 24.9 or > 30 kg/m2
- Intervention Study:
- Serum folate < 30 nmol/L
- MTHFR677CC or MTHFR677CT genotype
Exclusion Criteria:
- Currently pregnant, pregnancy within past 12 months
- Greater than 2 previous pregnancies
- Use of prescription drugs other than oral contraceptives
- Chronic disease (diabetes, hypertension,epilepsy,cancer, kidney disease, CVD)
- Acute illness (pneumonia, urinary tract infection, mononucleosis)
- Use of antibiotics in past 30 days
- Current smoker
- Use of dietary supplements including multivitamins in past 30 days
- Habitual consumption of fortified ready-to-eat cereals
- Significant weight change in past 12 months
- Typical alcohol consumption of 2 or more drinks per day
- INTERVENTION: all above plus serum folate > 30 nmol/L; MTHFR677TT genotype
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