Actively Recruiting

Phase 2
Age: 18Years - 25Years
FEMALE
ID07271316

Birth Control Supplement Study to Evaluate Alii Supplement for Nutritional Depletion Symptoms in Hormonal Birth Control Users

Led by Texas Christian University · Updated on 2026-01-14

68

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether the Alii Supplement can reduce symptoms related to nutritional depletion in women who use hormonal birth control pills. The study focuses on improvements in happiness, digestive health, mood swings, perceived vulnerability to disease, and energy levels. This randomized, double-blind trial involves 68 female university students aged 18 to 25 who have been on hormonal birth control for at least six months. Participants will be randomly assigned to take either the Alii Supplement or a placebo daily for 28 days. Each participant takes three capsules per day, with or without food, and receives daily reminders to help with adherence. The Alii Supplement contains multiple vitamins and nutrients aimed at addressing nutritional depletion, while the placebo contains inactive ingredients. After 28 days, participants complete follow-up surveys to assess changes in the targeted symptoms. Throughout the study, participants will fill out online surveys at the start and end of the 28-day period to measure happiness, mood swings, digestive health, vulnerability to disease, and energy. The research team will compare these measures before and after supplement use to see if the Alii Supplement has an effect. The study includes two visits to the research office for survey completion, and participants are monitored for their adherence to taking the capsules.

CONDITIONS

Brief Title

Alii Supplement Study

Who Can Participate

Age: 18Years - 25Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be female and aged 18 to 25 years
  • Participants must be currently using the hormonal birth control pill for at least six months
  • Participants must be willing to take a daily supplement for 28 days
  • Participants must be willing to complete follow-up surveys
  • Participants must have no food or medication allergies that prevent safe supplement use
  • Participants must not be taking vitamins or must agree to abstain from vitamins during the study
  • If possible, participants should not be taking medications that affect psychological states
  • Preference for participants using one-month hormonal birth control pills rather than three-month pills if possible
Not Eligible

You will not qualify if you...

  • Participants who are naturally cycling and not using hormonal birth control
  • Participants unwilling to take a daily supplement
  • Participants unwilling to complete follow-up surveys
  • Participants using hormonal birth control pills for less than six months
  • If possible, participants using three-month hormonal birth control pills
  • Participants with food or medication allergies preventing supplement use
  • Participants currently taking vitamins and unwilling to abstain during the study
  • If possible, participants currently taking medications affecting psychological states such as SSRIs or ADHD medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 28 days

Participants take either the Alii supplement or a placebo daily for 28 days. They will receive daily reminders to take their capsules and complete surveys about their symptoms before and after treatment.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Texas Christian University

Fort Worth, Texas, United States, 76109

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Research Team

S

Sarah E Hill, PhD

M

Melissa M Brillhart

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial