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

NCT ID: NCT06873412

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-12-01

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.

Conditions

Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotic group

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

Group Type: ACTIVE_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of the study will last for 3 months, and each subject will be followed up 3 times (month 0, Month 1, Month 2, month 3).

Placebo group

maltodextrin, take 1 piece (2.0 g) daily

Group Type: PLACEBO_COMPARATOR

Placbo

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of the study will last for 3 months, and each subject will be followed up 3 times (month 0, Month 1, Month 2, month 3).

Interventions

Probiotic

The experimental phase of the study will last for 3 months, and each subject will be followed up 3 times (month 0, Month 1, Month 2, month 3).

Intervention Type: DIETARY_SUPPLEMENT

Placbo

The experimental phase of the study will last for 3 months, and each subject will be followed up 3 times (month 0, Month 1, Month 2, month 3).

Intervention Type: DIETARY_SUPPLEMENT

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 -

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Bu Shurui

Role: CONTACT

18930819609@163.com

18930809609

Other Identifiers

WK20250302

Identifier Type: -

Identifier Source: org_study_id