Status:
RECRUITING
Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota
Lead Sponsor:
Peking University People's Hospital
Conditions:
People With High Body Fat Percentage
People With High Visceral Fat Area
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of this study was to investigate the changes in visceral fat area and associated indicators in individuals with high body fat percentage under the intervention of barley green, elucidate the c...
Eligibility Criteria
Inclusion
- Age 18-65 years old, gender is not limited; Body fat percentage exceeding the upper limit of the standard range: male \> 20%, female \> 28%; Visceral fat area \> 100cm2; Willing to accept the assessment and sign informed consent.
Exclusion
- ① Patients currently receiving weight-loss medications (e.g., incretin-based therapies such as GLP-1 receptor agonists) or medications that improve insulin resistance (e.g., metformin or other insulin-sensitizing agents), or anti-inflammatory agents with documented effects on inflammatory markers (including but not limited to lipid-lowering agents, hypoglycemic agents, antihypertensives, urate-lowering agents, etc.);
- Patients concurrently using nutritional supplements or functional foods (e.g., phytochemicals, health supplements) with demonstrated effects on reducing body fat or visceral adiposity;
- Patients regularly consuming prebiotics, probiotics, or other microbiota-modulating agents;
- Patients with diseases severely affecting nutrient digestion or absorption (e.g., chronic diarrhea, severe constipation, active inflammatory bowel disease, active gastrointestinal ulcers, history of gastrointestinal resection, cholecystitis/post-cholecystectomy syndrome, etc.);
- Patients with cardiovascular/cerebrovascular diseases (e.g., coronary artery disease, heart failure, arrhythmias, cardiomyopathies, cerebral infarction, cerebral hemorrhage, cerebral arteritis), grade 3 hypertension, stroke, chronic hepatitis, malignancies, anemia, psychiatric disorders, cognitive impairment, epilepsy, acute-phase gout, nephrolithiasis, or renal insufficiency;
- ⑥ Patients with hepatic dysfunction (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] levels exceeding 3 times the upper limit of normal \[ULN\]) or renal dysfunction (serum creatinine exceeding ULN);
- ⑦ Patients with active infectious diseases (e.g., tuberculosis, HIV/AIDS);
- ⑧ Patients with severe allergies to any component of the investigational products;
- ⑨ Pregnant or lactating individuals;
- ⑩ Patients with physical disabilities or other conditions deemed ineligible by investigators (e.g., clinically significant comorbidities not listed above).
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06886048
Start Date
March 19 2025
End Date
October 1 2025
Last Update
April 4 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Xicheng District, China, 100044