Alii Supplement Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2026-04-29

Brief Summary

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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.

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Detailed Description

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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

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Nutrient Deficiency Happiness Digestive Health Vulnerability to Disease Mood Swings Energy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

The primary investigator and co-investigator will have knowledge as to what group each participant is in. However, the research assistants who will be the only individuals interacting with the participants will not have knowledge as to what group each participant is in.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Alii Supplement

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No