Food and Alcohol Behavior Study: Meaningful Enhancement (FAB:ME)

Oklahoma State University Center for Health Sciences

Status: Active, not recruiting

Conditions: Folate Deficiency

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Methyl Folate

Study type: Interventional

Funder types: Other

Identifiers

NCT04095052

2022001

Details and patient eligibility

About

This study will determine how folate supplementation affects both serum and red blood cell folate status in females ages 18 -24 years old. Additionally, this study will determine the effect of folate supplementation on mood, cognition, and sleep patterns. This study will fill a crucial gap in understanding how folate status affects a variety of health behaviors in order to better inform public health practice and prevention.

Full description

Preliminary studies conducted by the investigator's team indicate that 95.7% of previous participants (all alcohol consuming, ages 14-24), were below the threshold for red blood cell (RBC) folate status for women of childbearing potential. Understanding how the interaction of behaviors (alcohol use, nutrient supplementation, diet) contribute to sub-optimal folate status is critical to developing and expanding upon evidence-based FASD prevention programs. Notably, how nutrient supplementation might improve overall folate status in a group with poor folate status and other behaviors that confound the absorption of folate. Because the participants do not view themselves as being at risk for unwanted pregnancy, their motivation to take a supplement for a future pregnancy is very low. This team seeks to collect data on how folate supplementation might improve individually measured outcomes, like cognition and mood, so that interventions might be developed focusing on these individual outcomes.

After becoming aware of the study, prospective participants will undergo a screening questionnaire for inclusion/exclusion criteria. Once the participant meets the inclusion criteria, the study will be fully explained and written informed consent will be handed out. Participants will be randomized in a single-blind manner (participant) in a 1:1 ratio to the Methyl Folate supplement (1,000 mcg, once daily) or placebo (once daily).

Enrollment: 20 patients

Sex: Female

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females restricted to those living in the United States
• Not currently using hormonal birth control
• Must experience menses
• Must begin the study exactly one week after the start of their menstrual cycle
• Folate consumption must be less than or equal to 250 micrograms of dietary folate equivalents (DFEs)

Exclusion criteria

• Current use of a folate supplement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Methyl Folate

Experimental group

Description:

Participants will receive a capsule containing 1,000 mcg methyl folate and microcrystalline cellulose orally once per day for 15 days.

Treatment:

Dietary Supplement: Methyl Folate

Placebo

Placebo Comparator group

Description:

Participants will receive a microcrystalline cellulose capsule orally once per day for 15 days.

Treatment:

Dietary Supplement: Placebo