Alii Supplement Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-25
SponsorTexas Christian University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Alii Supplement
Dietary supplementThis 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.
Placebo
Other interventionThis 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
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Alii SupplementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Levels of Perceived Vulnerability to Disease Scale after 1 Month of Drug Usage
Participants complete the Perceived Infectability Subscale (Duncan et al., 2009). For each scale item, 1 = Strongly disagree to 7 = Strongly agree. Higher scores indicate a higher perceived vulnerability to disease.
Time frame
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 (Joseph et al., 2004). For each scale item, 1 = Never... 4 = Often. Higher scores indicate higher levels of happiness.
Time frame
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 (Roalfe et al., 2008). For each scale item, 1: All of the time... 6: None of the time. Higher scores indicate better digestive health.
Time frame
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 (Yoon et al., 2021). 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.
Time frame
From day 1 of supplement usage to the end of treatment at 4 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov