About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Probiotic
Dietary supplementThe 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).
Placbo
Dietary supplementThe 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).
Treatment groups
Trial outcomes
Primary outcomes
Changes in alanine aminotransferase (ALT) levels
ALT level decline indicates improved liver function, assessed via blood tests.
Changes in aspartate aminotransferase (AST) levels
AST level decline indicates improved liver function, assessed via blood tests.
Secondary outcomes
Changes in basal metabolic rate
The Mifflin-St Jeor equation was used to evaluate the subject's basal metabolic level, reflecting the body's energy expenditure at rest.
Metabolic index
Blood pressure: Evaluate the effects of the tested product on age-related cardiovascular health and monitor changes in systolic and diastolic blood pressure.
Gamma-glutamyltransferase (GGT)
Evaluate the effects of the tested product on liver-related components. GGT: The unit is U/L.
Total bilirubin (TBil)
Evaluate the effects of the tested product on liver-related components. TBil: Unit: μmol/L.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: