Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Adults With Hypercholesterolemia
Led by Moon (Guangzhou) Biotechnology Co., Ltd. · Updated on 2025-12-30
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of AKM Lab-01, a probiotic supplement, in adults aged 40 to 60 years with hypercholesterolemia. This study is a randomized, double-blind, placebo-controlled trial designed to compare daily oral doses of AKM Lab-01 against a placebo in participants with elevated cholesterol levels. The goal is to assess changes in cholesterol and other health markers to better understand the potential benefits of this probiotic for managing lipid levels. Participants will be randomly assigned to receive either the AKM Lab-01 probiotic capsule or a placebo capsule once daily, taken within half an hour after breakfast for three months. The probiotic dose is specified as 34 billion total fermentation units per day. The study involves a triple-blind design to ensure unbiased results, and both groups will be monitored throughout the treatment period. During the study, participants will have clinical assessments and provide blood and stool samples at baseline, day 30, and day 90 to measure changes in total cholesterol, LDL cholesterol, blood lipids, blood glucose, blood pressure, uric acid, weight, HbA1c, waist and hip circumference, and body fat percentage. Safety will be monitored by tracking adverse events for up to four months. Participants will commit to following the treatment regimen and visit schedule over the study duration to support comprehensive data collection and safety monitoring.
CONDITIONS
Brief Title
An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 40-60 years (inclusive), regardless of gender
- Diagnosed with hypercholesterolemia within specified cholesterol and triglyceride ranges
- Overweight or obese with BMI between 24.0 and 40.0 kg/m²
- No metabolic control medications taken in the past month
- Blood lipids controlled only by lifestyle changes for at least 1 month prior to screening
- Able to communicate, understand, and adhere to long-term medication
- Fertile participants must agree to use medically approved contraception during the trial; females must have a negative pregnancy test and not be breastfeeding
- Voluntarily agree to participate with signed informed consent and commit to treatment and visit schedules
You will not qualify if you...
- Use of metabolic control drugs within the past month or currently
- Secondary hyperlipidemia due to specific medical conditions
- Severe comorbidities requiring urgent treatment
- Severe primary diseases or psychiatric disorders
- Family history of inherited metabolic disorders
- Current use of liver-affecting medications
- History of bariatric surgery
- Acute or chronic unstable diseases deemed unsuitable by investigator
- Liver or kidney dysfunction beyond defined lab limits
- Clinically significant lab abnormalities or elevated serum amylase
- Acute diabetic complications in past 3 months
- Gastrointestinal surgery within the past year
- Allergies or hypersensitivity to the study product
- Use of antibiotics, probiotics, or prebiotics within 3 months prior
- Excessive alcohol use in the past 10 years
- Pregnant or breastfeeding individuals
- Other exclusions as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants take the study capsules daily by mouth for 3 months to assess safety and efficacy on cholesterol levels.
3 visits (Baseline, Day 30, Day 90)
Duration - Up to 1 month after treatment
Participants are monitored for adverse events and safety outcomes after completing treatment.
1 visit
Trial Site Locations
Total: 1 location
1
PKUCare Luzhong Hospital
Zibo, Shandong, China
Actively Recruiting
Research Team
B
Baojia Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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