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Search / Trial NCT06886048

Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Mar 14, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of barley green, a type of green barley supplement, on reducing visceral fat in people who have a high body fat percentage. Visceral fat is the fat stored around our organs, and having too much of it can lead to health problems. Participants in the trial will be divided into two groups: one group will take the barley green supplement along with a balanced, calorie-restricted diet, while the other group will only follow the diet without the supplement. The study aims to see how these two approaches affect visceral fat levels and to understand how barley green might influence gut health and fat reduction.

To be eligible for the trial, participants need to be between 18 and 65 years old and have a body fat percentage above 20% for men or above 28% for women, as well as a visceral fat area of over 100 cm². Participants will receive assessments and support throughout the study, including nutritional evaluations and blood tests to check their health. It’s important to note that certain individuals, such as those on specific medications or with certain health conditions, may not be eligible to participate. This trial is a step towards understanding how barley green can be used as a nutritional strategy for managing body fat and improving overall health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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).

About Peking University People's Hospital

Peking University People's Hospital is a leading clinical research institution in China, renowned for its commitment to advancing medical knowledge and improving patient care through innovative clinical trials. Affiliated with Peking University, the hospital integrates cutting-edge research, comprehensive healthcare services, and a multidisciplinary team of experts to facilitate the development of new therapies and medical interventions. With a strong focus on patient safety and ethical standards, Peking University People's Hospital is dedicated to conducting rigorous clinical trials that contribute to the global medical community and enhance the quality of life for patients.

Locations

Beijing, Xicheng District, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported