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Exercise, Milk Thistle, and Lactobacillus to Influence Plasma Bilirubin

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 baseline (prior to initiation of study)
Awards & highlights
Pivotal Trial

Summary

This trial will test if Milk Thistle extract and Lactobacillus Gasseri supplements, alone or with exercise, can help reduce body fat in obese individuals. These supplements may increase a substance in the blood that helps burn fat. Lactobacillus gasseri has been shown to inhibit dietary fat absorption and reduce abdominal fat in both rats and humans. The study will compare different combinations to see which works best.

Eligible Conditions
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (prior to initiation of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (prior to initiation of study) for reporting.

Treatment Details

Study Objectives

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~540

Find a Location

Who is running the clinical trial?

University of KentuckyLead Sponsor
194 Previous Clinical Trials
223,658 Total Patients Enrolled
7 Trials studying Obesity
4,876 Patients Enrolled for Obesity
Kyle FlackLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Obesity
32 Patients Enrolled for Obesity
~9 spots leftby Dec 2025
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