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Milk Thistle (MT) for Obesity

Phase 3
Waitlist Available
Research Sponsored by University of Kentucky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (immediately after 12 week exercise and/or supplement intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (immediately after 12 week exercise and/or supplement intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fat mass
Lean mass
Plasma FGF21
+3 more
Secondary outcome measures
Liver function

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: MT + EXExperimental Treatment2 Interventions
Participants in the MT + EX group will be supplemented with Milk Thistle extract and exercise for 12 weeks
Group II: MTExperimental Treatment1 Intervention
Participants in the MT group will be supplemented with Milk Thistle extract for 12 weeks
Group III: LAC + EXExperimental Treatment2 Interventions
Participants in the LAC + EX group will be supplemented with Lactobacillus Gassri and exercise for 12 weeks
Group IV: LACExperimental Treatment1 Intervention
Participants in the LAC group will be supplemented with Lactobacillus Gassri for 12 weeks
Group V: EXExperimental Treatment2 Interventions
Participants in the EX group will perform aerobic exercise, 5 days per week for 12 weeks
Group VI: CONPlacebo Group1 Intervention
Participants in the CON group will be supplemented with maltodextrin pills made to look like the pills received by the MT and LAC groups for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Milk Thistle (MT)
2021
Completed Phase 3
~50
Lactobacillus Gasseri (LAC)
2021
Completed Phase 3
~50
Exercise (EX)
2021
Completed Phase 3
~50
Control (CON)
2014
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

University of KentuckyLead Sponsor
185 Previous Clinical Trials
226,600 Total Patients Enrolled
7 Trials studying Obesity
10,512 Patients Enrolled for Obesity
Kyle FlackLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Obesity
32 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
Indiana
What site did they apply to?
University of Kentucky- Nutrition Assessment Lab
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I am 6 ft 240 lbs and at my biggest I was 265 lbs. I have lost weight, but not exactly in a regimented healthy manner. I am looking to gain insight into my weight and how to stabilize it in the healthiest way possible.
PatientReceived no prior treatments
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.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is there medication or supplements involved? Is it compensated?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Kentucky- Nutrition Assessment Lab: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Exercise, Milk Thistle, and Lactobacillus to Influence Plasma Bilirubin
Kyle Flack 2021. "Exercise, Milk Thistle, and Lactobacillus to Influence Plasma Bilirubin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04717726.
~10 spots leftby Apr 2025
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