Study Evaluating Safety and Effectiveness of AKM Lab-01 Probiotic in Adults With High Cholesterol Aged 35 to 75

What this Trial Is About

Researchers are evaluating the safety and effectiveness of AKM Lab-01, a probiotic, in adults aged 35 to 75 with hypercholesterolemia. This randomized, double-blind, placebo-controlled study aims to compare daily oral doses of AKM Lab-01 to a placebo in participants with elevated cholesterol levels, including those with overweight or obesity. The trial is sponsored by Moon Guangzhou Biotechnology Co., Ltd. Participants will receive either an enteric-coated capsule of AKM Lab-01 or a placebo once daily by mouth within half an hour after breakfast for three months. The probiotic dose is 34 billion total fermentation units per day. The study includes a parallel design with two groups one receiving the probiotic and the other receiving placebo. Baseline clinical data, blood samples, and stool specimens will be collected before and after the treatment period. During the trial, participants will undergo assessments of blood lipid levels, fasting blood glucose, blood pressure, uric acid, weight, HbA1c, waist and hip circumference, and body fat percentage at baseline, day 30, and day 90. Safety monitoring includes tracking adverse events and serious adverse events for up to four months. Participants are expected to adhere to the medication schedule and visit timelines as per the study protocol, contributing to the evaluation of AKM Lab-01s effects on cholesterol and related metabolic parameters.

An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia