Completed

FASUPPEffect of Obesity and Folic Acid Supplementation on Gene-specific DNA Methylation in Women of Reproductive Age

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Folic acid

+ Folic acid

Dietary Supplement
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 40 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of Georgia
Last updated: July 4, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01841658
Principal SponsorUniversity of Georgia
Last updated: July 4, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightObesity

Criteria

6 inclusion criteria required to participate
Body Mass index 18.5 to 24.9 or > 30 kg/m2
Female 18-40 yr
Intervention Study
MTHFR677CC or MTHFR677CT genotype
Show More Criteria
12 exclusion criteria prevent from participating
Acute illness (pneumonia, urinary tract infection, mononucleosis)
Chronic disease (diabetes, hypertension,epilepsy,cancer, kidney disease, CVD)
Current smoker
Currently pregnant, pregnancy within past 12 months
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Folic acid, tablet, 800 mcg, daily, eight weeks. Normal Weight individuals, each will serve as her own control.

Group II

Experimental
Folic acid, tablet, 800 mcg, daily, eight weeks. Obese individuals, each will serve as her own control.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Georgia

Athens, United StatesOpen University of Georgia in Google Maps
CompletedOne Study Center