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.

Study Overview

• Status: Recruiting
• Conditions: People With High Body Fat Percentage; People With High Visceral Fat Area
• Intervention / Treatment: Dietary supplement: barley green

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingxuan Cui; Phone Number: +8601088324216; Email: cmxjuicy@bjmu.edu.cn

Study Locations

• China
  • Xicheng District
    • Beijing, Xicheng District, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Mingxuan Cui; Phone Number: +8601088324216; Email: cmxjuicy@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: intervention group	Dietary supplement: barley green; Oral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024PHB574-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No