Alii Supplement Study

NCT07271316 | Completed Phase 2 Results

• 1 other identifier: IRB#2025-383
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Hormonal Birth Control; Nutritional Depletion; Dietary Supplement

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Levels of Perceived Vulnerability to Disease Scale After 1 Month of Drug Usage

  Participants completed the Perceived Infectability Subscale of the Perceived Vulnerability to Disease Scale. For each scale item, 1 = Strongly disagree to 7 = Strongly agree. The subscale scores can range from 1 to 7. Higher scores indicate a higher perceived vulnerability to disease. Higher scores indicate a worse outcome. Subscale items were averaged together to create a perceived infectability score.

  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. For each scale item, 1 = Never... 4 = Often. Higher scores indicate higher levels of happiness. Higher scores indicate a better outcome. Happiness scores can range from 1 to 4. Scores for happiness level were created by taking the mean of all scale items.

  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. For each scale item, 1: All of the time... 6: None of the time. Higher scores indicate better digestive health. Higher scores indicate a better outcome. Scores could range from 1 to 6. Scores for digestive health were calculated by taking the mean of all the scale items.

  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. 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. Higher scores indicate a worse outcome. Results reported relate to the Lability Subscale. Scores on the subscale can range from 0 to 3. Scores for mood swings were calculated by taking the mean of all the Lability Subscale items.

  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. For each scale item, 1 = Yes, that is true... 5 = No, that is not true. Higher scores indicate higher energy levels. Higher scores indicate a better outcome. Scores for energy could range from 1 to 5. Scores for energy were calculated by taking the mean of all the scale items.

  From day 1 of supplement usage to the end of treatment at 4 weeks.

Study Arms (1)

Alii Supplement

EXPERIMENTAL

Participants will be 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

Interventions

Alii Supplement DIETARY_SUPPLEMENT

Seeking to examine 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.

Alii Supplement

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Christian University: lead

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76109, United States

Location

Related Publications (3)

• 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.

  PMID: 7636775 BACKGROUND

• 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.

  PMID: 15588455 BACKGROUND

• 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.

  PMID: 34441044 BACKGROUND

Limitations and Caveats

Originally, we were going to assess whether capsule type (supplement vs placebo) and time (pre vs post) influenced the variables of interest. However, due to recruitment restrictions and changes in the supplement formulation, we were unable to do have the placebo. Specifically, there were not enough participants who were willing and eligible to participate to reach the target sample size. Moreover, recruitment cannot continue as the supplement formulation is changing from a capsule to a gummy.

Results Point of Contact

• Title: Sarah E. Hill
• Organization: Texas Christian University

s.e.hill@tcu.edu

817-257-6424

Study Officials

• Sarah E Hill, PhD

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Originally, participants were going to receive the supplement or a placebo. Due to recruitment and timing restrictions, all participants received the supplement. Only the primary investigator and co-investigator had knowledge as to what group each participant is in. The research assistants who were the only individuals interacting with the participants did not know if the participants received a placebo or the supplement. Moreover, participants did not know if they received a placebo or the supplement.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: January 12, 2026
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: July 13, 2026
• Results First Posted: July 13, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)