The purpose of this study was to assess the safety and efficacy of AKM Lab-01 in subjects with hypercholesterolemia. This study will be conducted as a randomized, double-blind, placebo-controlled trial, eligible hypercholesterolemic participants were administered daily oral doses of either AKM Lab-01 or a placebo. Baseline clinical parameters, blood samples, and stool specimens were collected before and after the intervention for comparative analysis.
Aged 35-75 years (inclusive), regardless of gender;
Patients diagnosed with hypercholesterolemia (5.2 mmol/L ≤ TC <6.2 mmol/L, or 3.4 mmol/L ≤ LDL-C <5.0 mmol/L), with or without hypertriglyceridemia (1.7 mmol/L ≤ TG <4.5 mmol/L) or mixed hyperlipidemia (defined as: 1.7 mmol/L ≤ TG <4.5 mmol/L and 5.2 mmol/L ≤ TC <6.2 mmol/L; or 1.7 mmol/L ≤ TG <4.5 mmol/L and 3.4 mmol/L ≤ LDL-C <5.0 mmol/L; or 1.7 mmol/L ≤ TG <4.5 mmol/L, 5.2 mmol/L ≤ TC <6.2 mmol/L and 3.4 mmol/L ≤ LDL-C <5.0 mmol/L);
Accompanied by overweight/obesity (24.0 ≤ BMI ≤40.0 kg/m²);
Have not taken any metabolic control medications (for lipid, weight, or blood glucose) within the past month;
Have taken any metabolic control medications (e.g., lipid-lowering, blood glucose-regulating, or weight-loss drugs) within the past month or are currently taking such medications.
Patients with secondary hyperlipidemia caused by conditions such as nephrotic syndrome, liver diseases, hypothyroidism, renal failure, etc..
Have severe comorbidities requiring immediate treatment, including uncontrolled diabetes, hypertriglyceridemia, cerebrovascular diseases, etc., as determined by the investigator.
Have severe primary diseases (e.g., hepatic, renal, or hematopoietic system disorders) or psychiatric conditions.
Parallel
Probiotic
Dietary supplementSubjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.
Placebo
Dietary supplementSubjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.
Changes in TC and LDL-C
The changes in serum TC and LDL-C of participants from baseline
AE and SAE
During the trial, all subjects are observed and recorded for any adverse events (AEs) that occur during the study period, the incidence, type and severity of serious adverse events (SAEs), including clinical symptoms and abnormalities in vital signs, and abnormalities in lab tests, with determination of the correlation between them and the investigational drug.
Changes in Blood Lipids
Changes of participants from baseline in HDL-C and Triglyceride
Changes in FBG
Changes of participants from baseline in Fasting blood glucose (FBG)
Changes in Blood Pressure
Changes of participants from baseline in blood pressure
Changes in Uric Acid
Changes of participants from baseline in Uric Acid
Click on the lead sponsor to view all of their trials.
