Food and Alcohol Behavior Study: Meaningful Enhancement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2024-08-14

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Folate Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to a condition that receives a vitamin supplement (methyl folate), or a placebo group. Both the condition and placebo group will receive the same size pill once daily for 15 days and the pills will look the same. The condition group will receive a gel capsule containing the methyl folate supplement and a microcrystalline cellulose fiber. The placebo group will receive the same size gel capsule containing only the microcrystalline cellulose filler. The methyl folate supplement is the upper tolerable limit set by the Institute of Medicine. Taking more that the upper limit of 1000 mcg of methyl folate may be harmful; for this reason, it is important to discontinue vitamin use while enrolled in the study. Participants assigned to both the condition and placebo groups will be directly observed taking the pill during each daily appointment.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

This is a single-blind study. The participants will be blinded.

Study Groups

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Methyl Folate

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

Group Type EXPERIMENTAL

Methyl Folate

Intervention Type DIETARY_SUPPLEMENT

1,000 mcg methyl folate and Microcrystalline Cellulose in a capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Microcrystalline Cellulose capsule

Interventions

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Methyl Folate

1,000 mcg methyl folate and Microcrystalline Cellulose in a capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

Microcrystalline Cellulose capsule

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)