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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | ||
| intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| barley green | Dietary Supplement | Oral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| height in centimeters | Height in centimeters are measured by Manual Height Ruler at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| weight in kilograms |
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Inclusion Criteria:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingxuan Cui | Contact | +8601088324216 | cmxjuicy@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Xicheng District | 100044 | China |
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Weight in kilograms 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 |
| BMI in kg/m^2 | Weight and height will be combined to report BMI in kg/m^2 at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| body fat rate in % | Body fat rates 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 |
| muscle mass in kilograms | Muscle masses 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 |
| basal metabolic rate in kcal | Basal metabolic rates 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 |
| skeletal muscle mass in kilograms | Skeletal muscle masses 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 |
| blood pressure in mmHg | Blood pressures are measured by electronic blood pressure monitor at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| waist circumference in millimeters | Waist circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| hip circumference in millimeters | Hip circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| upper arm circumference in millimeters | Upper arm circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| left hand grip strength in pound-force | Left hand grip strengths are measured by grip dynamometer at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| right hand grip strength in pound-force | Right hand grip strengths are measured by grip dynamometer at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| triceps skinfold thickness in millimeters | Triceps skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| subscapular horn skinfold thickness in millimeters | Subscapular horn skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| abdominal skinfold thickness in millimeters | Abdominal skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| food intake dose in grams | Data of food intake doses are taken by food frequency questionnaire and 3-day food diary at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| uric acid levels in umol/L | Uric acid levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| blood glucose in mmol/L | Blood glucose levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| total cholesterol in mmol/L | Total cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| triglycerides in mmol/L | Triglycerides levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| high-density lipoprotein cholesterol in mmol/L | High-density lipoprotein cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| low-density lipoprotein cholesterol in mmol/L | Low-density lipoprotein cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| white blood cell count in 10^9/L | White blood cell counts are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| hemoglobin in g/L | Hemoglobin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| glutamic-pyruvic transaminase in U/L | Glutamic-pyruvic transaminase levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| glutamic oxalacetic transaminase in U/L | Glutamic oxalacetic transaminase levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| albumin in g/L | Albumin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin B6 in ng/mL | Vitamin B6 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin B1 in ng/mL | Vitamin B1 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin B9 in ng/mL | Vitamin B9 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin B5 in ng/mL | Vitamin B5 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin B3 in ng/mL | Vitamin B3 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin B2 in ng/mL | Vitamin B2 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin B12 in ng/mL | Vitamin B12 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin A in ng/mL | Vitamin A levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin D in ng/mL | Vitamin D levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin E in ng/mL | Vitamin E levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| vitamin K in ng/mL | Vitamin K levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| cobalt in µg/L | Cobalt levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| nickel in µg/L | Nickel levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| selenium in µg/L | Selenium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| arsenic in µg/L | Arsenic levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| platinum in µg/L | Platinum levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| copper in mg/L | Copper levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| molybdenum in µg/L | Molybdenum levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| zinc in mg/L | Zinc levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| manganese in µg/L | Manganese levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| magnesium in mg/L | Magnesium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| cadmium in µg/L | Cadmium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| iron in mg/L | Iron levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| thallium in µg/L | Thallium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| lead in µg/L | Lead levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| calcium in mg/L | Calcium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| cortisol in µg/dL | Cortisol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| growth hormone in ng/mL | Growth hormone levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| fasting insulin in uU/mL | Fasting insulin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| thyroid-stimulating hormone in uIU/mL | Thyroid-stimulating hormone levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| free thyroxine in pmol/L | Free thyroxine levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| free triiodothyronine in pmol/L | Free triiodothyronine levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| IL-1β in pg/mL | IL-1β levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| IL-6 in pg/mL | IL-6 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| IL-10 in pg/mL | IL-10 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| leptin in pg/mL | Leptin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| adiponectin in µg/mL | Adiponectin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| Hardness of liver in kPa | Hardness of liver is measured by Liver Ultrasound Elastography at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| Controlled Attenuation Parameter in dB/m | Controlled Attenuation Parameter is measured by Liver Ultrasound Elastography at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| Alpha diversity (Shannon index, Chao1) | Alpha diversity is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| Beta diversity (Bray-Curtis dissimilarity) | Beta diversity is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| Relative abundance of specific taxa (e.g., Firmicutes/Bacteroidetes ratio) | Relative abundance of specific taxa is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |
| Predicted functional pathways (via metagenomic analysis) | Predicted functional pathways are analyzed via metagenomic analysis after 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment. | From enrollment to the end of treatment at 8 weeks |