NCT06873412Not yet recruitingNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 84
- Primary Endpoint
- Changes in alanine aminotransferase (ALT) levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The age of the subjects is 40-80 years old;
- •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.
Exclusion Criteria
- •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);
- •Patients who received probiotics within 1 month before taking the experimental drug;
- •Recent history of gastrointestinal bleeding, obstruction, perforation, tumor and other serious organic diseases;
- •Aminotransferase index > 3 times the normal value;
- •Kidney disease (creatinine index higher than normal);
- •Patients with serious psychological and mental diseases, resulting in the inability to express themselves normally;
- •Patients with infectious liver diseases, such as hepatitis B and C;
- •The female subject is breastfeeding or has a positive pregnancy test result during the screening period or during the test -
Arms & Interventions
Placebo group
Placebo Comparator
maltodextrin, take 1 piece (2.0 g) daily
Intervention: Placbo (Dietary Supplement)
Probiotic group
Active Comparator
Intervention group of polygonatum-probiotics complex, take 1 piece (2.0 g) daily
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in alanine aminotransferase (ALT) levels
Time Frame: 3 months
ALT level decline indicates improved liver function, assessed via blood tests.
Changes in aspartate aminotransferase (AST) levels
Time Frame: 3 months
AST level decline indicates improved liver function, assessed via blood tests.
Secondary Outcomes
- Uric acid(3 months)
- Weight(3 months)
- BMI (body mass index)(3 months)
- Changes in basal metabolic rate(3 months)
- Metabolic index(3 months)
- Gamma-glutamyltransferase (GGT)(3 months)
- Total bilirubin (TBil)(3 months)
- Fasting blood glucose(3 months)
- Total cholesterol(3 months)
- Triglyceride(3 months)
- Low-density lipoprotein (LDL)(3 months)
- High density lipoprotein (HDL)(3 months)
- Changes in malondialdehyde (MDA) levels(3 months)
- Changes in the level of superoxide dismutase (SOD)(3 months)
- Changes in glutathione (GSH) levels(3 months)
- Fatigue Severity Scale (FSS)(3 months)
- Pittsburgh Sleep Quality Index (PSQI)(3 months)
- Short-chain fatty acids (SCFAs)(3 months)
- Fecal flora structure (16S rRNA sequencing)(3 months)
- Inflammatory factor(3 months)
- Fatty liver morphology(3 months)
Investigators
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