Clinical trial NCT06873412: Effects of Compound Probiotics-Polygonatum Sibiricum on Liver Health and Metabolism in Middle-aged and Elderly People
Official title: The Regulatory Effect of Probiotics-Polygonatum Sibiricum on Liver Health and Metabolic Disorders in Middle-Aged and Elderly People: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatty Liver
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-12
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the regulatory effects of Huangqian-biobacteria compound preparation on liver health and related metabolic disorders in middle-aged and elderly people, observe its effects on liver function indexes, basal metabolic rate, markers of oxidative stress, inflammatory factors and intestinal microecology, and evaluate the incidence of adverse reactions in subjects during the 3-month intervention period.


Eligibility criteria: Inclusion Criteria:

1. The age of the subjects is 40-80 years old; 2. The subject meets one of the following metabolic disease components: ① abdominal B - ultrasound shows fatty liver or fat infiltration; ② arterial blood pressure is higher than 130/85mmHg, or the subject is on antihypertensive treatment; ③ prediabetes or type 2 diabetes, with fasting blood glucose above 6.1mmol/L; ④ overweight or obesity, with BMI of 24.0kg/m² or more, or male waist circumference of 90cm or more, female waist circumference of 85cm or more, or excessive body fat content and percentage.

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Exclusion Criteria:

1. People who are allergic to any of the pharmaceutical ingredients used in this study; A history of alcohol abuse (drinking more than 14 units of alcohol per week :1 unit = 285mL for beer, 25mL for spirits, 100mL for wine);
2. Patients who received probiotics within 1 month before taking the experimental drug;
3. Recent history of gastrointestinal bleeding, obstruction, perforation, tumor and other serious organic diseases;
4. Aminotransferase index \> 3 times the normal value;
5. Kidney disease (creatinine index higher than normal);
6. Patients with serious psychological and mental diseases, resulting in the inability to express themselves normally;
7. Patients with infectious liver diseases, such as hepatitis B and C;
8. The female subject is breastfeeding or has a positive pregnancy test result during the screening period or during the test -

Primary outcomes:
measure: Changes in alanine aminotransferase (ALT) levels
timeFrame: 3 months
measure: Changes in aspartate aminotransferase (AST) levels
timeFrame: 3 months
Secondary outcomes:
measure: Changes in basal metabolic rate
timeFrame: 3 months
measure: Metabolic index
timeFrame: 3 months
measure: Gamma-glutamyltransferase (GGT)
timeFrame: 3 months
measure: Total bilirubin (TBil)
timeFrame: 3 months
measure: Uric acid
timeFrame: 3 months
measure: Weight
timeFrame: 3 months
measure: BMI (body mass index)
timeFrame: 3 months
measure: Fasting blood glucose
timeFrame: 3 months
measure: Total cholesterol
timeFrame: 3 months
measure: Triglyceride
timeFrame: 3 months
measure: Low-density lipoprotein (LDL)
timeFrame: 3 months
measure: High density lipoprotein (HDL)
timeFrame: 3 months
measure: Changes in malondialdehyde (MDA) levels
timeFrame: 3 months
measure: Changes in the level of superoxide dismutase (SOD)
timeFrame: 3 months
measure: Changes in glutathione (GSH) levels
timeFrame: 3 months
measure: Fatigue Severity Scale (FSS)
timeFrame: 3 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 months
measure: Short-chain fatty acids (SCFAs)
timeFrame: 3 months
measure: Fecal flora structure (16S rRNA sequencing)
timeFrame: 3 months
measure: Inflammatory factor
timeFrame: 3 months
measure: Fatty liver morphology
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
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