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Nutrient DeficiencyPhase 2NCT07271316

Alii Supplement Study

A Phase 2 study testing Alii Supplement in people with Nutrient Deficiency and Happiness, run by Texas Christian University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 25 years, women only
Conditions the study is for
Nutrient Deficiency, Happiness, Digestive Health
What is being tested?
Alii Supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
12 Jan 2026to 20 Apr 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Christian University

    Fort Worth, Texas, 76109

Other trials in United States

About this study

Official title: 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?

Read more

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.

Read the 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.

Being tested
Alii Supplement
Keywords
Hormonal Birth Control, Nutritional Depletion, Dietary Supplement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alii SupplementDietary 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.

Study groups in NCT07271316
Study groupRoleWhat they receive
Alii SupplementExperimentalParticipants 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.
Receives: Dietary Supplement: Alii Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start12 Jan 2026
  3. Primary completion20 Apr 2026
  4. Study completion20 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07271316
Sponsor's protocol ID
IRB#2025-383
Status last verified
Jun 2026
First submitted
27 Nov 2025
Last updated
13 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 7636775
  • 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.

    PubMed 15588455
  • 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.

    PubMed 34441044

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alii Supplement in people with Nutrient Deficiency and Happiness, run by Texas Christian University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Levels of Perceived Vulnerability to Disease Scale After 1 Month of Drug Usage (time frame: From day 1 of supplement usage to the end of treatment at 4 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07271316, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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Alii Supplement Study (NCT07271316) | AzTrials