Peking University People's Hospital
Beijing, Xicheng District, 100044, China
Location status: Recruiting
Recruiting
NCT Number: NCT06886048
Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
barley green
Dietary SupplementOral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day
Primary outcomes
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visceral fat area in cm2
Time frame: From enrollment to the end of treatment at 8 weeks.
Visceral fat areas are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
Secondary outcomes
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height in centimeters
Time frame: From enrollment to the end of treatment at 8 weeks
Height in centimeters are measured by Manual Height Ruler at two time points: the day of enrollment and 8 weeks after enrollment.
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weight in kilograms
Time frame: From enrollment to the end of treatment at 8 weeks
Weight in kilograms are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
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BMI in kg/m^2
Time frame: From enrollment to the end of treatment at 8 weeks
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.
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body fat rate in %
Time frame: From enrollment to the end of treatment at 8 weeks
Body fat rates are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
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muscle mass in kilograms
Time frame: From enrollment to the end of treatment at 8 weeks
Muscle masses are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
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basal metabolic rate in kcal
Time frame: From enrollment to the end of treatment at 8 weeks
Basal metabolic rates are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
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skeletal muscle mass in kilograms
Time frame: From enrollment to the end of treatment at 8 weeks
Skeletal muscle masses are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
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blood pressure in mmHg
Time frame: From enrollment to the end of treatment at 8 weeks
Blood pressures are measured by electronic blood pressure monitor at two time points: the day of enrollment and 8 weeks after enrollment.
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waist circumference in millimeters
Time frame: From enrollment to the end of treatment at 8 weeks
Waist circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.
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hip circumference in millimeters
Time frame: From enrollment to the end of treatment at 8 weeks
Hip circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.
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upper arm circumference in millimeters
Time frame: From enrollment to the end of treatment at 8 weeks
Upper arm circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.
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left hand grip strength in pound-force
Time frame: From enrollment to the end of treatment at 8 weeks
Left hand grip strengths are measured by grip dynamometer at two time points: the day of enrollment and 8 weeks after enrollment.
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right hand grip strength in pound-force
Time frame: From enrollment to the end of treatment at 8 weeks
Right hand grip strengths are measured by grip dynamometer at two time points: the day of enrollment and 8 weeks after enrollment.
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triceps skinfold thickness in millimeters
Time frame: From enrollment to the end of treatment at 8 weeks
Triceps skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.
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subscapular horn skinfold thickness in millimeters
Time frame: From enrollment to the end of treatment at 8 weeks
Subscapular horn skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.
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abdominal skinfold thickness in millimeters
Time frame: From enrollment to the end of treatment at 8 weeks
Abdominal skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.
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food intake dose in grams
Time frame: From enrollment to the end of treatment at 8 weeks
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.
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uric acid levels in umol/L
Time frame: From enrollment to the end of treatment at 8 weeks
Uric acid levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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blood glucose in mmol/L
Time frame: From enrollment to the end of treatment at 8 weeks
Blood glucose levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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total cholesterol in mmol/L
Time frame: From enrollment to the end of treatment at 8 weeks
Total cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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triglycerides in mmol/L
Time frame: From enrollment to the end of treatment at 8 weeks
Triglycerides levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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high-density lipoprotein cholesterol in mmol/L
Time frame: From enrollment to the end of treatment at 8 weeks
High-density lipoprotein cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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low-density lipoprotein cholesterol in mmol/L
Time frame: From enrollment to the end of treatment at 8 weeks
Low-density lipoprotein cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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white blood cell count in 10^9/L
Time frame: From enrollment to the end of treatment at 8 weeks
White blood cell counts are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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hemoglobin in g/L
Time frame: From enrollment to the end of treatment at 8 weeks
Hemoglobin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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glutamic-pyruvic transaminase in U/L
Time frame: From enrollment to the end of treatment at 8 weeks
Glutamic-pyruvic transaminase levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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glutamic oxalacetic transaminase in U/L
Time frame: From enrollment to the end of treatment at 8 weeks
Glutamic oxalacetic transaminase levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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albumin in g/L
Time frame: From enrollment to the end of treatment at 8 weeks
Albumin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin B6 in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin B6 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin B1 in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin B1 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin B9 in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin B9 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin B5 in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin B5 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin B3 in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin B3 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin B2 in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin B2 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin B12 in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin B12 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin A in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin A levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin D in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin D levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin E in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin E levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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vitamin K in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Vitamin K levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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cobalt in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Cobalt levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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nickel in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Nickel levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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selenium in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Selenium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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arsenic in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Arsenic levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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platinum in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Platinum levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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copper in mg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Copper levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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molybdenum in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Molybdenum levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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zinc in mg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Zinc levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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manganese in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Manganese levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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magnesium in mg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Magnesium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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cadmium in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Cadmium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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iron in mg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Iron levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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thallium in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Thallium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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lead in µg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Lead levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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calcium in mg/L
Time frame: From enrollment to the end of treatment at 8 weeks
Calcium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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cortisol in µg/dL
Time frame: From enrollment to the end of treatment at 8 weeks
Cortisol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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growth hormone in ng/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Growth hormone levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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fasting insulin in uU/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Fasting insulin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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thyroid-stimulating hormone in uIU/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Thyroid-stimulating hormone levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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free thyroxine in pmol/L
Time frame: From enrollment to the end of treatment at 8 weeks
Free thyroxine levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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free triiodothyronine in pmol/L
Time frame: From enrollment to the end of treatment at 8 weeks
Free triiodothyronine levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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IL-1β in pg/mL
Time frame: From enrollment to the end of treatment at 8 weeks
IL-1β levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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IL-6 in pg/mL
Time frame: From enrollment to the end of treatment at 8 weeks
IL-6 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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IL-10 in pg/mL
Time frame: From enrollment to the end of treatment at 8 weeks
IL-10 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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leptin in pg/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Leptin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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adiponectin in µg/mL
Time frame: From enrollment to the end of treatment at 8 weeks
Adiponectin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
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Hardness of liver in kPa
Time frame: From enrollment to the end of treatment at 8 weeks
Hardness of liver is measured by Liver Ultrasound Elastography at two time points: the day of enrollment and 8 weeks after enrollment.
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Controlled Attenuation Parameter in dB/m
Time frame: From enrollment to the end of treatment at 8 weeks
Controlled Attenuation Parameter is measured by Liver Ultrasound Elastography at two time points: the day of enrollment and 8 weeks after enrollment.
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Alpha diversity (Shannon index, Chao1)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
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Beta diversity (Bray-Curtis dissimilarity)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
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Relative abundance of specific taxa (e.g., Firmicutes/Bacteroidetes ratio)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
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Predicted functional pathways (via metagenomic analysis)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Peking University People's Hospital
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 20, 2025
- Registry last updated
- Mar 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.