Study Summary
This trial will test whether red blood cell release of heme and catabolism to bilirubin is an essential process for reducing body fat, and whether Milk Thistle extract or Lactobacillus Gasseri can extend bilirubin circulating times to decrease body fat further.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
6 Primary · 1 Secondary · Reporting Duration: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
6 Treatment Groups
MT + EX
1 of 6
LAC + EX
1 of 6
EX
1 of 6
MT
1 of 6
LAC
1 of 6
CON
1 of 6
Experimental Treatment
Non-Treatment Group
30 Total Participants · 6 Treatment Groups
Primary Treatment: Milk Thistle (MT) · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 50 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Indiana | 100.0% |
What site did they apply to?
| University of Kentucky- Nutrition Assessment Lab | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I've been trying for 20+ years to lose weight...fad diets, exercise, lifestyle changes, doctors, weight loss programs, pills, etc. Some methods worked better than others but I have never come close to achieving my goal weight. While I have been able to lose over 100lbs over a 4 year period, I am still struggling, and am, in fact, gaining again. The excess weight is affecting my daily life like it never has before."
How many prior treatments have patients received?
| 3+ | 100.0% |
Frequently Asked Questions
Does this research project only allow volunteers who are under 55 years old?
"According to the age requirements set out in this clinical trial's inclusion criteria, patients must be between 18 and 50 years old." - Anonymous Online Contributor
Could I join the ranks of this research project?
"This study has room for approximately 30 participants that should meet the following criteria: be between 18 and 50 years old with a body mass index indicative of obesity." - Anonymous Online Contributor
How many people are being given the chance to participate in this research?
"The clinical trial is currently ongoing, with a most recent update on 1/11/2022. 30 participants are needed from 1 locations." - Anonymous Online Contributor
Can more people join this clinical trial?
"Yes, that is accurate. The listing on clinicaltrials.gov indicates that this trial is currently recruiting patients. This particular study was first posted on February 24th, 2021 and has been updated as recently as January 11th, 2022. They are looking for a total of 30 participants at 1 location." - Anonymous Online Contributor
Has the FDA greenlit Milk Thistle as an official drug?
"MT has received a 3 because it is a phase 3 trial, which means that while there is some data supporting efficacy, multiple rounds of data support safety." - Anonymous Online Contributor