Alii Supplement Study

Birth Control Supplement Study

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.

Study Overview

• Status: Recruiting
• Conditions: Happiness; Nutrient Deficiency; Energy; Digestive Health; Mood Swings; Vulnerability to Disease
• Intervention / Treatment: Dietary supplement: Alii Supplement; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sarah E Hill, PhD; Phone Number: 817-257-6424; Email: s.e.hill@tcu.edu
• Study Contact Backup: Name: Melissa M Brillhart; Email: m.brillhart@tcu.edu

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76109
      • Recruiting
      • Texas Christian University
      • Contact: Melissa Brillhart; Phone Number: 8172574989; Email: m.brillhart@tcu.edu
      • Principal Investigator: Sarah E Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Half of the participants will be randomly assigned by researchers to take a placebo. The researchers who are giving the participant the placebo will not know if they are giving the participant a placebo or the supplement. The placebo being used is the Magic Bullet Placebo Pill. Participants will take 3 placebo pills per day for 28 days.	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
Experimental: Alii Supplement; Half of the participants will be randomly assigned by researchers to take the Alii Supplement. The investigators who are giving the participant the Alii supplement will not know if the participants are receiving a placebo or the supplement. Participants will take 3 pills per day for 28 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From day 1 of supplement usage to the end of treatment at 4 weeks.
Change from Baseline in Levels of Happiness after 1 Month of Drug Usage	Participants complete the Short Depression-Happiness Scale (Joseph et al., 2004). For each scale item, 1 = Never... 4 = Often. Higher scores indicate higher levels of happiness.	From day 1 of supplement usage to the end of treatment at 4 weeks.
Change from Baseline in Levels of Digestive Health after 1 Month of Drug Usage	Participants complete a modified version of the Birmingham IBS Symptom Questionnaire (Roalfe et al., 2008). For each scale item, 1: All of the time... 6: None of the time. Higher scores indicate better digestive health.	From day 1 of supplement usage to the end of treatment at 4 weeks.
Change from Baseline in Levels of Mood Swings after 1 Month of Drug Usage	Participants complete the Modified Version of the Mood Instability Questionnaire-Trait (Yoon et al., 2021). For each scale item, 0 = not at all true, 1 = hardly true, 2 = moderately true, and 3 = exactly true. Higher scores indicate more mood swings.	From day 1 of supplement usage to the end of treatment at 4 weeks.
Change from Baseline in Levels of Energy after 1 Month of Drug Usage	Participants complete the Multidimensional Fatigue Inventory (General Fatigue and Physical Fatigue Subscales; Smets et al., 1995). For each scale item, 1 = Yes, that is true... 5 = No, that is not true. Higher scores indicate higher energy levels.	From day 1 of supplement usage to the end of treatment at 4 weeks.

Collaborators and Investigators

• Sponsor: Texas Christian University
• Investigators: Principal Investigator: Sarah E Hill, PhD, Texas Christian University

Publications and helpful links

General Publications

• Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
• Joseph S, Linley PA, Harwood J, Lewis CA, McCollam P. Rapid assessment of well-being: The Short Depression-Happiness Scale (SDHS). Psychol Psychother. 2004 Dec;77(Pt 4):463-78. doi: 10.1348/1476083042555406.
• Yoon J, Ha TH, Oh S, Park YS, Ryoo HA, Yu HA, Hong SJ, Cho N, Lee CW, Jang Y, Lee W, Kim YR, Park KH, Park J, Park JY, Myung W. Development and Validation of the Mood Instability Questionnaire-Trait (MIQ-T). Medicina (Kaunas). 2021 Aug 18;57(8):838. doi: 10.3390/medicina57080838.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): April 29, 2026
• Study Completion (Estimated): April 29, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Dietary Supplement; Nutritional Depletion; Hormonal Birth Control
• Other Study ID Numbers: IRB#2025-383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared either via OSF or upon request once the manuscript has been published. All data will be de-identified prior to sharing with other researchers. Supporting information (e.g., study protocol, informed consent forms, etc.) may be made available upon request. No time frame has been determined for length of time data are available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No