Clinical trial NCT04095052: Food and Alcohol Behavior Study: Meaningful Enhancement
Official title: Food and Alcohol Behavior Study: Meaningful Enhancement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Folate Deficiency
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Red blood cell folate status
timeFrame: Baseline
measure: Change in serum folate status
timeFrame: Change from baseline serum folate status at day 1
measure: Change in serum folate status
timeFrame: Change from day 1 serum folate status at day 2
measure: Change in serum folate status
timeFrame: Change from day 2 serum folate status at day 3
measure: Change in serum folate status
timeFrame: Change from day 3 serum folate status at day 4
measure: Change in serum folate status
timeFrame: Change from day 4 serum folate status at day 5
measure: Change in serum folate status
timeFrame: Change from day 5 serum folate status at day 6
measure: Change in serum folate status
timeFrame: Change from day 6 serum folate status at day 7
measure: Change in serum folate status
timeFrame: Change from day 7 serum folate status at day 8
measure: Change in serum folate status
timeFrame: Change from day 8 serum folate status at day 9
measure: Change in serum folate status
timeFrame: Change from day 9 serum folate status at day 10
measure: Change in serum folate status
timeFrame: Change from day 10 serum folate status at day 11
measure: Change in serum folate status
timeFrame: Change from day 11 serum folate status at day 12
measure: Change in serum folate status
timeFrame: Change from day 12 serum folate status at day 13
measure: Change in serum folate status
timeFrame: Change from day 13 serum folate status at day 14
measure: Change in serum folate status
timeFrame: Change from day 14 serum folate status at day 15
measure: Change in gastrointestinal symptoms
timeFrame: Change from baseline gastrointestinal health status at day 7
measure: Change in gastrointestinal symptoms
timeFrame: Change from day 7 gastrointestinal health status at day 15
measure: Change in dietary folate consumption
timeFrame: Change from baseline dietary folate consumption at day 7
measure: Change in dietary folate consumption
timeFrame: Change from day 7 dietary folate consumption at day 15
measure: Change in mood
timeFrame: Change from baseline mood at day 7
measure: Change in mood
timeFrame: Change from day 7 mood at day 15
measure: Change in cognition
timeFrame: Change from baseline cognitive functioning at day 7
measure: Change in cognition
timeFrame: Change from day 7 cognitive functioning at day 15
measure: Change in sleep patterns
timeFrame: Change from baseline sleep patterns at day 7
measure: Change in sleep patterns
timeFrame: Change from day 7 sleep patterns at day 15
measure: Change in hair, nails, and skin satisfaction
timeFrame: Change from baseline hair, nails, and skin satisfaction at day 7
measure: Change in hair, nails, and skin satisfaction
timeFrame: Change from day 7 hair, nails, and skin satisfaction at day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University Center for Health Sciences
state: Oklahoma
Study officials:
References: