Trial Outcomes & Findings for Alii Supplement Study (NCT NCT07271316)
NCT ID: NCT07271316
Last Updated: 2026-07-13
Results Overview
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.
COMPLETED
PHASE2
16 participants
From day 1 of supplement usage to the end of treatment at 4 weeks.
2026-07-13
Participant Flow
There were not enough participants who were willing and eligible to take part in the study to reach the target sample size. Moreover, recruitment cannot continue as the supplement formulation is changing to a gummy. Thus, all participants received the nutritional supplement. Research assistants and participants were unaware that the participants all received the nutritional supplement as the determination to end the study without the placebo was made after the in person part 1 sessions ended.
Participant milestones
| Measure |
Alii Supplement
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.
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant did not answering all of the mood swings question, so their data for this measure was unable to be analyzed
Baseline characteristics by cohort
| Measure |
Alii Supplement
n=16 Participants
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.
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Age, Customized
Age 18-25 Years
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16 Participants
n=16 Participants
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Sex: Female, Male
Female
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16 Participants
n=16 Participants
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Sex: Female, Male
Male
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0 Participants
n=16 Participants
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Race/Ethnicity, Customized
White/Caucasian
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6 Participants
n=16 Participants
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Race/Ethnicity, Customized
Hispanic/Latino
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3 Participants
n=16 Participants
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Race/Ethnicity, Customized
Mixed Race
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6 Participants
n=16 Participants
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Race/Ethnicity, Customized
Black / African American
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1 Participants
n=16 Participants
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Perceived Infectability
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4.09 Score on a Scale
STANDARD_DEVIATION 1.47 • n=16 Participants
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Happiness
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3.49 Score on a scale
STANDARD_DEVIATION .38 • n=16 Participants
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Digestive Health
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1.54 Score on a scale
STANDARD_DEVIATION .52 • n=16 Participants
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Mood Swings
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1.98 Score on a scale
STANDARD_DEVIATION .67 • n=15 Participants • One participant did not answering all of the mood swings question, so their data for this measure was unable to be analyzed
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Energy
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3.31 Score on a scale
STANDARD_DEVIATION .78 • n=16 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Alii Supplement
n=16 Participants
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.
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Change From Baseline in Levels of Perceived Vulnerability to Disease Scale After 1 Month of Drug Usage
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4.14 Score on a Scale
Standard Deviation 1.40
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Alii Supplement
n=16 Participants
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.
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|---|---|
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Change From Baseline in Levels of Happiness After 1 Month of Drug Usage
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3.64 Score on a Scale
Standard Deviation .33
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Alii Supplement
n=16 Participants
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.
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|---|---|
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Change From Baseline in Levels of Digestive Health After 1 Month of Drug Usage
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1.59 Score on a Scale
Standard Deviation .55
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PRIMARY outcome
Timeframe: From day 1 of supplement usage to the end of treatment at 4 weeks.Population: One participant did not respond to one of the mood swings questions at time 1 and was therefore left out of the subsequent analyses.
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.
Outcome measures
| Measure |
Alii Supplement
n=15 Participants
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.
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|---|---|
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Change From Baseline in Levels of Mood Swings After 1 Month of Drug Usage
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1.80 Score on a Scale
Standard Deviation .49
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Alii Supplement
n=16 Participants
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.
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Change From Baseline in Levels of Energy After 1 Month of Drug Usage
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3.52 Score on a scale
Standard Deviation .57
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Adverse Events
Alii Supplement
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alii Supplement
n=16 participants at risk
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.
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Gastrointestinal disorders
A participant notified that they were experiencing stomach discomfort.
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6.2%
1/16 • From part 1 in-person enrollment until the follow-up, which took 28 days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place