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NCT Number: NCT06873412

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

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.

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Key information

Conditions

Fatty Liver Digestive System Diseases Liver Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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 -

Treatment and study plan

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).

Primary outcomes

  1. Changes in alanine aminotransferase (ALT) levels

    Time frame: 3 months

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

  2. Changes in aspartate aminotransferase (AST) levels

    Time frame: 3 months

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

Secondary outcomes

  1. Changes in basal metabolic rate

    Time frame: 3 months

    The Mifflin-St Jeor equation was used to evaluate the subject's basal metabolic level, reflecting the body's energy expenditure at rest.

  2. Metabolic index

    Time frame: 3 months

    Blood pressure: Evaluate the effects of the tested product on age-related cardiovascular health and monitor changes in systolic and diastolic blood pressure.

  3. Gamma-glutamyltransferase (GGT)

    Time frame: 3 months

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

  4. Total bilirubin (TBil)

    Time frame: 3 months

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

  5. Uric acid

    Time frame: 3 months

    Evaluate the effects of the tested product on liver-related components. Uric acid: unit: μmol/L.

  6. Weight

    Time frame: 3 months

    Evaluate the effects of the tested product on body weight. Weight: Unit: kg.

  7. BMI (body mass index)

    Time frame: 3 months

    The effects of the product on body mass index were evaluated. BMI: Unit: kg/m².

  8. Fasting blood glucose

    Time frame: 3 months

    Evaluate the effect of the tested product on blood sugar levels. Fasting blood glucose: the unit is mmol/L.

  9. Total cholesterol

    Time frame: 3 months

    The effect of the tested product on lipid levels was evaluated. Total cholesterol: Unit: mmol/L.

  10. Triglyceride

    Time frame: 3 months

    The effect of the tested product on lipid levels was evaluated. Triglyceride: The unit is mmol/L.

  11. Low-density lipoprotein (LDL)

    Time frame: 3 months

    The effect of the tested product on lipid levels was evaluated. LDL: The unit is mmol/L.

  12. High density lipoprotein (HDL)

    Time frame: 3 months

    The effect of the tested product on lipid levels was evaluated. HDL: The unit is mmol/L.

  13. Changes in malondialdehyde (MDA) levels

    Time frame: 3 months

    Evaluate the effects of test products on oxidative stress levels. MDA: The unit is μmol/L.

  14. Changes in the level of superoxide dismutase (SOD)

    Time frame: 3 months

    Evaluate the effects of test products on oxidative stress levels. SOD: The unit is U/mL.

  15. Changes in glutathione (GSH) levels

    Time frame: 3 months

    Evaluate the effects of test products on oxidative stress levels. GSH: Unit: μmol/L

  16. Fatigue Severity Scale (FSS)

    Time frame: 3 months

    Evaluate the fatigue severity of the tested product. FSS score: The unit is points, ranging from 1 to 7 points.

    1 score: No fatigue Score 7: Extreme fatigue Higher score: indicates more severe fatigue

  17. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 3 months

    Participants' overall sleep quality over the past three months was assessed. PSQI score: The unit is points, ranging from 0 to 21 points. 0 score: Best sleep quality 21 points: worst sleep quality Higher score: indicates poorer sleep quality

  18. Short-chain fatty acids (SCFAs)

    Time frame: 3 months

    hort-chain fatty acids: Short-chain fatty acids such as acetic acid, propionic acid, and butyric acid are analyzed in stool samples by gas chromatography-mass spectrometry (GC-MS) or high performance liquid chromatography (HPLC).

    Acetic acid: unit: μmol/g fecal matter. Propionic acid: The unit is μmol/g feces. Butyric acid: The unit is μmol/g feces.

  19. Fecal flora structure (16S rRNA sequencing)

    Time frame: 3 months

    16S rRNA sequencing: Bacterial 16S rRNA genes in fecal samples are analyzed by high-throughput sequencing techniques to determine the diversity and composition of the gut microbiota.

    Diversity index: such as Shannon index, Chao1 index, etc., used to measure the diversity of flora.

    Composition analysis: The relative abundance of major bacterial phyla, genera and species is determined by taxonomic analysis.

  20. Inflammatory factor

    Time frame: 3 months

    Changes in serum levels of inflammatory cytokines (IL-6, IL-1β, TNF-α, IP-10) : To evaluate the effect of the tested product on the inflammatory response and reflect the immune status of the body.

  21. Fatty liver morphology

    Time frame: 3 months

    Abdominal B-ultrasound: To evaluate the effect of the tested product on the morphology of fatty liver, reflecting the liver fat deposition.

Study contacts

Contact information is provided by the study sponsor or research team.

Bu Shurui

CONTACT

[email protected]

18930809609

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

The Regulatory Effect of Probiotics-Polygonatum Sibiricum on Liver Health and Metabolic Disorders in Middle-Aged and Elderly People: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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