Effects of Compound Probiotics-Polygonatum Sibiricum on Liver Health and Metabolism in Middle-aged and Elderly People

Wecare Probiotics

Status: Not yet enrolling

Conditions: Fatty Liver

Treatments: Dietary Supplement: Placbo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06873412

WK20250302

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups, including a placebo group

Probiotic group

Active Comparator group

Description:

Intervention group of polygonatum-probiotics complex, take 1 piece (2.0 g) daily

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

maltodextrin, take 1 piece (2.0 g) daily

Treatment:

Dietary Supplement: Placbo