Exercise, Milk Thistle, and Lactobacillus to Influence Plasma Bilirubin

PHASE3CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

February 24, 2021

Primary Completion Date

July 19, 2023

Study Completion Date

July 19, 2023

Conditions
Obesity
Interventions
DIETARY_SUPPLEMENT

Milk Thistle (MT)

Participants in the MT and EX + MT groups will be provided 900 mg of standardized milk thistle extract daily (300 mg three times per day before meals) over the 12-week regimen. We will use the standardized Jarrow Formulas Milk Thistle Veggie Caps containing 30:1 extract that is standardized to contain 80% total Milk Thistle seed flavonoids (polyphenols), including the critical Silymarin fractions isosilybinins A and B, silybinins A and B, silychristin and silydianin that is active against suppressing the UGT1A1 enzyme increasing plasma bilirubin. The capsules are free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Rationale for using this brand: There have been inconsistencies with previous studies that did not use a standardized silymarin extract, which may have contained low levels of the active polyphenolic flavonoids in the milk thistle plant, which varies in the plant's stems, leaves, roots, and flowers.

DIETARY_SUPPLEMENT

Lactobacillus Gasseri (LAC)

Participants in the LAC and LAC + EX groups will receive two doses of 3 billion CFU of lactobacillus gasseri per day for a total of 6 billion CFU, the recommended upper level for supplementation of probiotic cultures. We will use Swanson brand Lactobacillus gasseri, whose capsules are also free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Importantly, this brand uses acid-resistant designed release capsules to improve the viability of the lactobacillus in the human stomach.

BEHAVIORAL

Exercise (EX)

Participants in the EX, EX + MT, and EX + LAC groups will complete five weekly exercise sessions on their own, expending roughly 600 kcal per session. Participants will be provided a Polar A-300 heart rate monitor programmed for their individual attributes (height, weight, age, training status, gender), which gives a real-time estimate of energy expenditure during exercise. Participants will report to the lab once per week to download the exercise sessions and verify compliance. If participants are not compliant (defined as completing 85% of their assigned exercise sessions per month), they will be disqualified. This intervention has been successfully used by Dr. Flack in multiple studies to produce significant weight loss without dietary intervention in this population with a retention rate of over 90%

DIETARY_SUPPLEMENT

Control (CON)

Participants in the CON and EX group will receive a placebo (maltodextrin) made to look identical to the MT and LAC capsules.

Trial Locations (1)

40506

University of Kentucky- Nutrition Assessment Lab, Lexington

All Listed Sponsors
lead

Kyle Flack

OTHER

NCT04717726 - Exercise, Milk Thistle, and Lactobacillus to Influence Plasma Bilirubin | Biotech Hunter | Biotech Hunter