Alii Supplement Study

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Texas Christian University
Study ID
NCT07271316
Phase
PHASE2
Status
Recruiting
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Conditions

  • Digestive Health
  • Energy
  • Happiness
  • Mood Swings
  • Nutrient Deficiency
  • Vulnerability to Disease

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Alii Supplement — 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.
  • Placebo — 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

Study Details

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.

Key Dates

Start date
Jan 12, 2026
Status verified
Jan 2026
Primary completion
Apr 29, 2026
Completion
Apr 29, 2026

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: 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.
  • Experimental: 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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Christian UniversityFort WorthTexas76109
Melissa Brillhart
[email protected]
8172574989
Sarah E Hill (PRINCIPAL_INVESTIGATOR)

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By research site
Texas Christian University· Fort Worth, TX

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