This study is designed as a preliminary investigation to evaluate the weight-loss efficacy and safety of AKM Lab-01 in an overweight or obese population. It is an interventional, radomized, double-blind, placebo-controlled clinical trial. Participants who meet the eligibility criteria will be randomly assigned to receive AKM Lab-01 or a matching placebo. The intervention will be administered once daily for 3 months. Baseline metrics, along with blood, urine, and stool samples, will be collected from participants, before and after the AKM Lab-01 intervention. The analysis will focus on changes in body weight, blood lipids, blood glucose, and gut metagenomic profiles (from stool samples). Furthermore, metabolomic analysis of blood and stool samples will be conducted to explore the potential machanisms through which AMK Lab-01 influences body weight.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
A specific dose of AKM Lab-01 will be administered orally once daily for a period of 3 months.
Placebo will be administered orally once daily for a period of 3 months.
Guangzhou Huangpu District People's Hospital
Guangzhou, Guangdong, China
RECRUITINGChanges in BMI
Changes in BMI from baseline will be assessed
Time frame: Baseline, Day 30, Day 60, Day 90
Changes in body weight
Changes in body weight from baseline will be assessed.
Time frame: Baseline, Day 30, Day 60, Day 90
Changes in TC
Changes in serum TC from baseline will be assessed.
Time frame: Baseline, Day 90
Changes in HbA1c
Changes in HbA1c from baseline will be assessed.
Time frame: Baseline, Day 30, Day 90
Changes in Uric Acid
Changes in Uric Acid from baseline will be assessed.
Time frame: Baseline, Day30, Day90
Changes in Blood Pressure
Changes of systolic and diastolic blood pressure from baseline will be assessed.
Time frame: Baseline, Day 30, Day 60, Day 90
Changes in LDL-C
Changes in serum LDL-C from baseline will be assessed.
Time frame: Baseline, Day 90
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