Investigating the effects of barley green on body fat and gut microbiota
Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota
This study is testing if taking barley green along with a calorie-restricted diet can help people with high body fat reduce their belly fat and improve their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Xicheng District) |
| Trial ID | NCT06886048 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of barley green supplementation on visceral fat area in individuals with a high body fat percentage. Participants are randomly assigned to either a group receiving barley green along with a calorie-restricted diet or a control group following only the diet. The study will assess changes in body composition, metabolism, and gut microbiota to understand the mechanisms behind any observed effects. Clinical data and blood samples will be collected to support the analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a body fat percentage exceeding 20% for men and 28% for women, and a visceral fat area greater than 100 cm².
Not a fit: Patients currently taking weight-loss medications or supplements that affect body fat or gut microbiota may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural dietary intervention for reducing visceral fat and improving metabolic health.
How similar studies have performed: While there is ongoing research into dietary interventions for fat reduction, the specific use of barley green in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Beijing, Xicheng District
- Peking University People's Hospital — Beijing, Xicheng District, China (Recruiting)
Study contacts
- Study coordinator: Mingxuan Cui
- Email: cmxjuicy@bjmu.edu.cn
- Phone: +8601088324216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.