NCT06873412

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Mar 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

March 2, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

March 2, 2025

Last Update Submit

March 6, 2025

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (2)

  • Changes in alanine aminotransferase (ALT) levels

    ALT level decline indicates improved liver function, assessed via blood tests.

    3 months

  • Changes in aspartate aminotransferase (AST) levels

    AST level decline indicates improved liver function, assessed via blood tests.

    3 months

Secondary Outcomes (21)

  • Changes in basal metabolic rate

    3 months

  • Metabolic index

    3 months

  • Gamma-glutamyltransferase (GGT)

    3 months

  • Total bilirubin (TBil)

    3 months

  • Uric acid

    3 months

  • +16 more secondary outcomes

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

maltodextrin, take 1 piece (2.0 g) daily

Dietary Supplement: Placbo

Interventions

ProbioticDIETARY_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).

Probiotic group
PlacboDIETARY_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

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatty Liver

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Bu Shurui

CONTACT

1893080960918930819609@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2025

First Posted

March 12, 2025

Study Start

March 10, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 12, 2025

Record last verified: 2025-03