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Lactobacillus rhamnosus JL-1 in combination with soy protein isolate for improvement of non-alcoholic fatty liver disease

Lactobacillus rhamnosus JL-1 in combination with soy protein isolate for improvement of non-alcoholic fatty liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102957
Enrollment
Unknown
Registered
2025-05-22
Start date
2025-05-31
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD (Non-Alcoholic Fatty Liver Disease)

Interventions

intervention group:Powdered mixture of Lactobacillus rhamnosus JL-1 and soybean isolate protein
control group:5g maltodextrin

Sponsors

Jianhu County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Age >=18 years; 2. Diagnosis of fatty liver and/or pathology >=5% hepatocellular macrovesicular steatosis on clinical imaging; 3. Non-drinker or no history of excessive alcohol consumption (=24.0 kg/m^2, or waist circumference >=90 cm (men) and 85 cm (women), or excess body fat content and percent body fat; Arterial blood pressure >=130/85 mmHg, or on blood pressure-lowering medication; Fasting blood glucose >= 6.1 mmol/L, or 2 h post glycemic load blood glucose >= 7.8 mmol/L or HbA1c >= 5.7%, or history of type 2 diabetes mellitus, or HOMA-IR >= 2.5; Fasting serum TG >= 1.70 mmol/L, or on lipid-lowering drug therapy; Fasting serum TG >= 1.70 mmol/L or on lipid-lowering medication. Serum HDL <= 1.0 mmol/L (men) and 1.3 mmol/L (women) or on lipid-lowering medication.

Exclusion criteria

Exclusion criteria: 1.Alcoholic liver disease, hepatitis C virus infection, drug-induced fatty liver, hepatomegaly and malnutrition and other diseases that can lead to fatty liver; 2. tamoxifen, etamoxifen, valproate, methotrexate, glucocorticosteroids and other drug users; 3. total parenteral nutrition, severe intestinal disease, celiac disease, hypothyroidism, Cushing's syndrome, ß-lipoprotein deficiency anemia, lipid atrophy diabetes, Mauriac syndrome and other special conditions that lead to fatty liver; surgery patients, pregnant women; in the past three months have used probiotics or soy protein isolates related health food or health food or Mauriac syndrome, and other special conditions; surgery patients, pregnant women; in the last three months have used probiotics or soy protein isolates related health food or health food. Special cases of fatty liver caused by atrophic diabetes mellitus, Mauriac syndrome, etc.; 4. Surgery patients, pregnant women; 5. People who have used probiotics or soy protein isolate related health food or fortified food in the last 3 months.

Design outcomes

Primary

MeasureTime frame
Liver function test results;Liver ultrasound results;Serological indicators;Immunoinflammatory indicators;

Countries

China

Contacts

Public ContactYang Shen

Gastroenterology, Jianhu County People's Hospital

jhshenyang10283@sina.com+86 158 6202 5051

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026