Alii Supplement Study

Phase 2RecruitingNCT07271316

Texas Christian University68 enrolled

Overview

The goal of this clinical trial is to learn if the Alii Supplement can be used to reduce symptoms related to nutritional depletion in hormonal birth control pill users. The main questions it aims to answer are: Does usage of the supplement increase happiness, decrease perceived vulnerability to disease, increase digestive health, decrease mood swings, and increase energy? The investigators will compare the Alii Supplement to a placebo (a capsule that contains no drug) to see if the Alii Supplement works to reduce symptoms associated with nutritional depletion. Participants will: Take the placebo or Alii Supplement everyday for 28 days and visit the research office twice to fill out an online survey comprising of items examining the main outcome measures.

This randomized, double-blind clinical trial will look to examine the efficacy of the Alii supplement, compared to a placebo, on reducing symptoms related to nutritional depletion in hormonal birth control pill users. This clinical trial will be conducted on 68 female university students. Participants will fill out measures of happiness, mood swings, digestive health, vulnerability to disease, and energy at time 1. Participants will then be randomly assigned to take a placebo or the Alii supplement for 28 days. Specifically, participants will take three capsules per day, with or without food. Participants will receive daily reminders to take their capsules. After taking the placebo or the supplement for 28 days, participants will again fill out the same measures of happiness, mood swings, digestive health, vulnerability to disease, and energy. Differences in these outcomes over time will be assessed to determine if taking the Alii supplement can improve these outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Interventions

Alii SupplementDIETARY_SUPPLEMENT

This is the experimental group, looking to see how a supplement aiming to improve nutrition levels in hormonal birth control users may improve symptoms related to nutritional depletion. Per serving (3 capsules), the supplement contains 90 mg of Vitamin C, 25 μg of Vitamin D3, 135 mg of Vitamin E, 100 mg of Vitamin B1, 50 mg of Vitamin B2, 50mg of Vitamin B3, 50 mg of Vitamin B6, 567 μg DFE of Folate, 250 μg of Vitamin B12, 20mg of Pantothenic Acid, 100mg of Magnesium, 11mg of Zinc, 200 μg of Selenium, 300 mg of Tributyrin, and 50 mg of Coenzyme Q 10. The supplement also contains Hypromellose, Silicon Dioxide, Microcrystalline Cellulose, Magnesium Stearate, and Stearic Acid.

PlaceboOTHER

This is the control group, so that the investigators can compare potential effects of the Alii supplement to the control group. The placebo contains Hypromellose and Microcrystalline Cellulose

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must be on the hormonal birth control pill as the investigators are testing the effectiveness of a supplement for women who take the hormonal birth control pill * Participants must be willing to complete a follow up survey as this study will be multiple parts * Participants must be willing to take a daily supplement as this study is testing how a supplement influences a variety of psychological outcomes * Participants must be on the hormonal birth control pill for at least six months as participants who have been on the pill for less than 6 months may not be experiencing nutritional depletion yet * If the investigators are able to do so, the investigators will only recruit participants who take the one-month hormonal birth control pill rather than the three month hormonal birth control pill, as the investigators are going to have participants come in after 28 days (day 2 of pack 1 and day 2 of pack 2) and participants on the three-month HBC pill may be on a 21 day cycle. * Participants must have no food or medication allergies that will prevent the participants from safely taking the supplement * Participants must not be taking any vitamins or participant must report willingness to abstain from taking vitamins during the study as individuals who are already taking vitamins may not be experiencing nutritional depletion associated with hormonal birth control * If the investigators have the ability to do so, the investigators will only recruit participants who are not taking medications. Participants on various medications (e.g., SSRIs, ADHD medications, etc.) may report differing psychological states due to their medications, rather than the supplement. Therefore, it would be best to exclude those individuals if possible. Exclusion Criteria: * Participants cannot be naturally cycling as the investigators are testing a supplement for women on hormonal birth control * Participants cannot be unwilling to complete a follow up study because this is a multi-part study * Participants cannot be unwilling to take a supplement because the study centers around taking a supplement * Participants cannot be on the hormonal birth control pill for less than 6 months as participants who have been on the pill for less than 6 months may not be experiencing nutritional depletion yet * If the investigators are able to do so, participants cannot take the three month hormonal birth control pill, as the investigators are going to have participants come in after 28 days (day 2 of pack 1 and day 2 of pack 2) and participants on the three-month HBC pill may be on a 21 day cycle. * Participants cannot have any food or medication allergies that will prevent the participants from safely taking the supplement * Participants must not be taking any vitamins or participants must report willingness to abstain from taking vitamins during the study as individuals who are already taking vitamins may not be experiencing nutritional depletion associated with hormonal birth control * If the investigators have the ability to do so, the investigators will only recruit participants who are not taking medications. Participants on various medications (e.g., SSRIs, ADHD medications, etc.) may report differing psychological states due to their medications, rather than the supplement. Therefore, it would be best to exclude those individuals if possible.

Outcomes

Primary Outcomes

Change from Baseline in Levels of Perceived Vulnerability to Disease Scale after 1 Month of Drug Usage

Participants complete the Perceived Infectability Subscale (Duncan et al., 2009). For each scale item, 1 = Strongly disagree to 7 = Strongly agree. Higher scores indicate a higher perceived vulnerability to disease.