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

NCT06886048 | Recruiting

• 1 other identifier: 2024PHB574-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 clinical efficacy of barley green on human visceral fat, and preliminarily explore the mechanism by which barley green influences human visceral fat through gut microbiota analysis. Participants with high body fat percentage were recruited from the Clinical Nutrition Department of Peking University People's Hospital and randomly assigned to either an intervention group or a control group. The intervention group received a regimen combining barley green supplementation with a calorie-restricted balanced diet plan, while the control group followed only the calorie-restricted balanced diet plan. General clinical data were collected, nutritional assessments were conducted, and dynamic analyses of body composition and metabolism were performed. Venous blood samples were obtained for the measurement of metabolic and inflammation-related indices as well as gut microbiota characterization. By observing and comparing differences in visceral fat area and related parameters, as well as gut microbiota profiles between the two groups, this study provides a scientific foundation for the clinical application of barley green in medical nutrition interventions targeting populations with high body fat percentage.

Conditions

People With High Visceral Fat Area; People With High Body Fat Percentage

Outcome Measures

Primary Outcomes (1)

• visceral fat area in cm2

  Visceral fat areas are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (71)

• height in centimeters

  From enrollment to the end of treatment at 8 weeks

• weight in kilograms

  From enrollment to the end of treatment at 8 weeks

• BMI in kg/m^2

  From enrollment to the end of treatment at 8 weeks

• body fat rate in %

  From enrollment to the end of treatment at 8 weeks

• muscle mass in kilograms

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

control group

NO INTERVENTION

intervention group

EXPERIMENTAL

Dietary Supplement: barley green

Interventions

barley green DIETARY_SUPPLEMENT

Oral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day

intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Xicheng District, 100044, China

RECRUITING

Central Study Contacts

Mingxuan Cui

CONTACT

+8601088324216; cmxjuicy@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)