Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age

University of Georgia (UGA)

Status: Completed

Conditions: Neural Tube Defects; Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT01743196

UGAFOLATEPILOT

Details and patient eligibility

About

The purpose of this study is to determine if there is a difference in the short term response in serum folate after a single dose of folic acid in normal weight and obese women of childbearing age.

Full description

Current recommendations established in 1998, specify that all women capable of becoming pregnant consume 400 micrograms of folate daily from supplements, fortified foods, or both, in addition to consuming food folate from a varied diet. Despite this recommendation, obese women have a lower folate status than women of normal weight which suggests that obesity may have a negative impact on folate metabolism. Therefore, the objective of this study is to determine if there are differences in the metabolic response to a single dose of folate between normal weight and obese women of child bearing age. The two groups of women will be given the currently recommended amount of folic acid, 400 micrograms, and blood samples will be taken before the vitamin is given and at various points afterwards to determine serum folate response to the folate dose. Results of this research should help determine if folate requirements are higher for obese than for non-obese women. The long-term goal of this and follow-up studies is to generate data that will contribute to the evidence base used by scientific advisory panels to determine whether dietary folate intake recommendations should be based on body weight.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female 18-35 yr
• Caucasian
• Body mass index 18.5 - 24.9 or > 30 kg/m2

Exclusion criteria

• Currently pregnant, pregnancy within the past 12 months
• Greater than 2 previous pregnancies
• Use of prescription drugs other than oral contraceptives
• Chronic disease (diabetes, hypertension, epilepsy, cancer, kidney disease, cardiovascular disease)
• Acute illness (e.g. pneumonia, urinary tract infection, mononucleosis)
• Use of antibiotics in past 30 days
• Current smoker
• Use of dietary supplements including multivitamins in the past 30 days
• Significant weight change in past 12 months
• Typical alcohol consumption of 2 or more drinks per day
• Consumption of any alcohol in the week preceding testing

Trial design

32 participants in 2 patient groups

Normal weight

Description:

Women with BMI 18.5 to 24.9 kg/m2

Obese

Description:

Women with BMI \> 30 kg/m2