Clinical trial NCT06886048: Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota
Official title: Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: People With High Body Fat Percentage
People With High Visceral Fat Area
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: visceral fat area in cm2
timeFrame: From enrollment to the end of treatment at 8 weeks.
Secondary outcomes:
measure: height in centimeters
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: weight in kilograms
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: BMI in kg/m^2
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: body fat rate in %
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: muscle mass in kilograms
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: basal metabolic rate in kcal
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: skeletal muscle mass in kilograms
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: blood pressure in mmHg
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: waist circumference in millimeters
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: hip circumference in millimeters
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: upper arm circumference in millimeters
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: left hand grip strength in pound-force
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: right hand grip strength in pound-force
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: triceps skinfold thickness in millimeters
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: subscapular horn skinfold thickness in millimeters
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: abdominal skinfold thickness in millimeters
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: food intake dose in grams
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: uric acid levels in umol/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: blood glucose in mmol/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: total cholesterol in mmol/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: triglycerides in mmol/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: high-density lipoprotein cholesterol in mmol/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: low-density lipoprotein cholesterol in mmol/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: white blood cell count in 10^9/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: hemoglobin in g/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: glutamic-pyruvic transaminase in U/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: glutamic oxalacetic transaminase in U/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: albumin in g/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin B6 in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin B1 in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin B9 in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin B5 in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin B3 in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin B2 in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin B12 in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin A in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin D in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin E in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: vitamin K in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: cobalt in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: nickel in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: selenium in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: arsenic in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: platinum in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: copper in mg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: molybdenum in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: zinc in mg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: manganese in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: magnesium in mg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: cadmium in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: iron in mg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: thallium in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: lead in µg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: calcium in mg/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: cortisol in µg/dL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: growth hormone in ng/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: fasting insulin in uU/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: thyroid-stimulating hormone in uIU/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: free thyroxine in pmol/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: free triiodothyronine in pmol/L
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: IL-1β in pg/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: IL-6 in pg/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: IL-10 in pg/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: leptin in pg/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: adiponectin in µg/mL
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Hardness of liver in kPa
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Controlled Attenuation Parameter in dB/m
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Alpha diversity (Shannon index, Chao1)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Beta diversity (Bray-Curtis dissimilarity)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Relative abundance of specific taxa (e.g., Firmicutes/Bacteroidetes ratio)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Predicted functional pathways (via metagenomic analysis)
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Xicheng District
Study officials:
References: