Fatty Liver
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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).
DIETARY_SUPPLEMENTPlacbo
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).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in alanine aminotransferase (ALT) levels | 3 months | ALT level decline indicates improved liver function, assessed via blood tests. |
| Changes in aspartate aminotransferase (AST) levels | 3 months | AST level decline indicates improved liver function, assessed via blood tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in malondialdehyde (MDA) levels | 3 months | Evaluate the effects of test products on oxidative stress levels. MDA: The unit is μmol/L. |
| Changes in the level of superoxide dismutase (SOD) | 3 months | Evaluate the effects of test products on oxidative stress levels. SOD: The unit is U/mL. |
| Changes in basal metabolic rate | 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. |
| Metabolic index | 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. |
| Gamma-glutamyltransferase (GGT) | 3 months | Evaluate the effects of the tested product on liver-related components. GGT: The unit is U/L. |
| Total bilirubin (TBil) | 3 months | Evaluate the effects of the tested product on liver-related components. TBil: Unit: μmol/L. |
| Uric acid | 3 months | Evaluate the effects of the tested product on liver-related components. Uric acid: unit: μmol/L. |
| Weight | 3 months | Evaluate the effects of the tested product on body weight. Weight: Unit: kg. |
| BMI (body mass index) | 3 months | The effects of the product on body mass index were evaluated. BMI: Unit: kg/m². |
| Low-density lipoprotein (LDL) | 3 months | The effect of the tested product on lipid levels was evaluated. LDL: The unit is mmol/L. |
| Total cholesterol | 3 months | The effect of the tested product on lipid levels was evaluated. Total cholesterol: Unit: mmol/L. |
| Triglyceride | 3 months | The effect of the tested product on lipid levels was evaluated. Triglyceride: The unit is mmol/L. |
| Changes in glutathione (GSH) levels | 3 months | Evaluate the effects of test products on oxidative stress levels. GSH: Unit: μmol/L |
| Fatigue Severity Scale (FSS) | 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 |
| Pittsburgh Sleep Quality Index (PSQI) | 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 |
| Short-chain fatty acids (SCFAs) | 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. |
| Fecal flora structure (16S rRNA sequencing) | 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. |
| Inflammatory factor | 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. |
| Fatty liver morphology | 3 months | Abdominal B-ultrasound: To evaluate the effect of the tested product on the morphology of fatty liver, reflecting the liver fat deposition. |
| Fasting blood glucose | 3 months | Evaluate the effect of the tested product on blood sugar levels. Fasting blood glucose: the unit is mmol/L. |
| High density lipoprotein (HDL) | 3 months | The effect of the tested product on lipid levels was evaluated. HDL: The unit is mmol/L. |
Contacts
Primary ContactBu Shurui
Outcome results
None listed