Alii supplement for birth-control-related nutrient symptoms
Birth Control Supplement Study
The Alii supplement will be tested to see whether it reduces nutrient-depletion symptoms like low energy, mood swings, digestive issues, and reduced happiness in women who use the hormonal birth control pill.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | Female |
| Sponsor | Texas Christian University Academic / other |
| Locations | 1 site (Fort Worth, Texas) |
| Trial ID | NCT07271316 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 2 trial will compare the Alii supplement to a placebo in 68 female university students who have used the hormonal birth control pill for at least six months. Participants will take three capsules daily for 28 days with daily reminders and complete online surveys at baseline and after 28 days. Outcomes include measures of happiness, mood swings, digestive health, perceived vulnerability to disease, and energy, with differences over time compared between the supplement and placebo groups. The study is conducted at Texas Christian University and involves two research visits for survey completion.
Who should consider this trial
Good fit: Women who have been taking a one-month hormonal birth control pill for at least six months, are willing to take a daily supplement for 28 days, and can complete two online surveys are ideal candidates.
Not a fit: People not using hormonal birth control, those on three-month contraceptive packs, or anyone unwilling to take daily capsules and complete follow-up surveys are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the supplement could modestly improve energy, mood stability, digestive health, and overall wellbeing for women using hormonal birth control.
How similar studies have performed: Prior research indicates hormonal contraceptives can deplete certain nutrients and small supplement trials have shown mixed, preliminary benefits rather than definitive results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fort Worth, Texas
- Texas Christian University — Fort Worth, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sarah E Hill, PhD — Texas Christian University
- Study coordinator: Sarah E Hill, PhD
- Email: s.e.hill@tcu.edu
- Phone: 817-257-6424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.