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.
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.
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.
- Conditions
- Nutrient Deficiency, Happiness, Digestive Health, Vulnerability to Disease, Mood Swings, Energy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Alii Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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.
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.
- First posted9 Dec 2025
- Study start12 Jan 2026
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Hill, Texas Christian University
- Investigators
- Sarah E Hill, PhD, Principal investigator, Texas Christian University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7636775Joseph 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 15588455Yoon 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth Control Supplement Study
- ClinicalTrials.gov ID
- NCT07271316
- Acronym / sponsor ID
- IRB#2025-383
- Conditions
- Nutrient Deficiency, Happiness, Digestive Health, Vulnerability to Disease, Mood Swings, Energy
- Keywords
- Hormonal Birth Control, Nutritional Depletion, Dietary Supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Posted 13 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alii Supplement | Experimental | Dietary Supplement: Alii SupplementParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alii SupplementSeeking 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. | Dietary supplement | Alii Supplement |
Primary outcome
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.
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.
Change From Baseline in Levels of Happiness After 1 Month of Drug Usage
Time frame: From day 1 of supplement usage to the end of treatment at 4 weeks.
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.
Change From Baseline in Levels of Digestive Health After 1 Month of Drug Usage
Time frame: From day 1 of supplement usage to the end of treatment at 4 weeks.
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.
Change From Baseline in Levels of Mood Swings After 1 Month of Drug Usage
Time frame: From day 1 of supplement usage to the end of treatment at 4 weeks.
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.
Change From Baseline in Levels of Energy After 1 Month of Drug Usage
Time frame: From day 1 of supplement usage to the end of treatment at 4 weeks.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7636775Smets 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.
- Background: PubMed 15588455Joseph 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.
- Background: PubMed 34441044Yoon 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah E Hill, PhD principal investigator
Texas Christian University
1 site in 1 country: see every site and its status.
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.