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

N/ANot Yet RecruitingNCT06873412

Wecare Probiotics Co., Ltd.84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fatty Liver

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).

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).

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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. \- 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 -

Outcomes

Primary Outcomes

Changes in alanine aminotransferase (ALT) levels

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

Time frame: 3 months

Changes in aspartate aminotransferase (AST) levels

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

Time frame: 3 months

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.

Time frame: 3 months

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

Gamma-glutamyltransferase (GGT)

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

Time frame: 3 months

Total bilirubin (TBil)

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

Time frame: 3 months

Uric acid

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

Time frame: 3 months

Weight

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

Central Contacts

Bu Shurui

CONTACT

18930809609 18930819609@163.com

Data from ClinicalTrials.gov

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Time frame: 3 months

BMI (body mass index)

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

Time frame: 3 months

Fasting blood glucose

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

Time frame: 3 months

Total cholesterol

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

Time frame: 3 months

Triglyceride

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

Time frame: 3 months

Low-density lipoprotein (LDL)

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

Time frame: 3 months

High density lipoprotein (HDL)

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

Time frame: 3 months

Changes in malondialdehyde (MDA) levels

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

Time frame: 3 months

Changes in the level of superoxide dismutase (SOD)

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

Time frame: 3 months

Changes in glutathione (GSH) levels

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

Time frame: 3 months

Fatigue Severity Scale (FSS)

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

Time frame: 3 months

Pittsburgh Sleep Quality Index (PSQI)

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

Time frame: 3 months

Short-chain fatty acids (SCFAs)

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.

Time frame: 3 months

Fecal flora structure (16S rRNA sequencing)

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.

Time frame: 3 months

Inflammatory factor

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.

Time frame: 3 months

Fatty liver morphology

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

Time frame: 3 months