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

ConditionFatty Liver
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorWecare Probiotics Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    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).

  • Placbo

    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).

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Probiotic groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in alanine aminotransferase (ALT) levels

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

Time frame
3 months
2

Changes in aspartate aminotransferase (AST) levels

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

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months
3

Gamma-glutamyltransferase (GGT)

Evaluate the effects of the tested product on liver-related components. GGT: The unit is U/L.

Time frame
3 months
4

Total bilirubin (TBil)

Evaluate the effects of the tested product on liver-related components. TBil: Unit: μmol/L.

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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