NCT07271316

Alii Supplement Study

Birth Control Supplement Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Texas Christian University · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nutrient Deficiency
• Happiness
• Digestive Health
• Vulnerability to Disease
• Mood Swings
• Energy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Alii 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.
OTHER	Placebo	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

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-04-29
• Completion: 2026-04-29
• First posted: 2025-12-09
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States