NCT06886048已完成不适用
Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- visceral fat area in cm2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
control group
No Intervention
intervention group
Experimental
干预措施: barley green (Dietary Supplement)
结局指标
主要结局
visceral fat area in cm2
时间窗: 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.
次要结局
- right hand grip strength in pound-force(From enrollment to the end of treatment at 8 weeks)
- triceps skinfold thickness in millimeters(From enrollment to the end of treatment at 8 weeks)
- subscapular horn skinfold thickness in millimeters(From enrollment to the end of treatment at 8 weeks)
- abdominal skinfold thickness in millimeters(From enrollment to the end of treatment at 8 weeks)
- food intake dose in grams(From enrollment to the end of treatment at 8 weeks)
- uric acid levels in umol/L(From enrollment to the end of treatment at 8 weeks)
- blood glucose in mmol/L(From enrollment to the end of treatment at 8 weeks)
- total cholesterol in mmol/L(From enrollment to the end of treatment at 8 weeks)
- triglycerides in mmol/L(From enrollment to the end of treatment at 8 weeks)
- high-density lipoprotein cholesterol in mmol/L(From enrollment to the end of treatment at 8 weeks)
- low-density lipoprotein cholesterol in mmol/L(From enrollment to the end of treatment at 8 weeks)
- white blood cell count in 10^9/L(From enrollment to the end of treatment at 8 weeks)
- hemoglobin in g/L(From enrollment to the end of treatment at 8 weeks)
- glutamic-pyruvic transaminase in U/L(From enrollment to the end of treatment at 8 weeks)
- glutamic oxalacetic transaminase in U/L(From enrollment to the end of treatment at 8 weeks)
- albumin in g/L(From enrollment to the end of treatment at 8 weeks)
- vitamin B6 in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin B1 in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin B9 in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin B5 in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin B3 in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin B2 in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin B12 in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin A in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin D in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin E in ng/mL(From enrollment to the end of treatment at 8 weeks)
- vitamin K in ng/mL(From enrollment to the end of treatment at 8 weeks)
- cobalt in µg/L(From enrollment to the end of treatment at 8 weeks)
- nickel in µg/L(From enrollment to the end of treatment at 8 weeks)
- selenium in µg/L(From enrollment to the end of treatment at 8 weeks)
- arsenic in µg/L(From enrollment to the end of treatment at 8 weeks)
- platinum in µg/L(From enrollment to the end of treatment at 8 weeks)
- copper in mg/L(From enrollment to the end of treatment at 8 weeks)
- molybdenum in µg/L(From enrollment to the end of treatment at 8 weeks)
- zinc in mg/L(From enrollment to the end of treatment at 8 weeks)
- manganese in µg/L(From enrollment to the end of treatment at 8 weeks)
- magnesium in mg/L(From enrollment to the end of treatment at 8 weeks)
- cadmium in µg/L(From enrollment to the end of treatment at 8 weeks)
- iron in mg/L(From enrollment to the end of treatment at 8 weeks)
- thallium in µg/L(From enrollment to the end of treatment at 8 weeks)
- lead in µg/L(From enrollment to the end of treatment at 8 weeks)
- calcium in mg/L(From enrollment to the end of treatment at 8 weeks)
- cortisol in µg/dL(From enrollment to the end of treatment at 8 weeks)
- growth hormone in ng/mL(From enrollment to the end of treatment at 8 weeks)
- fasting insulin in uU/mL(From enrollment to the end of treatment at 8 weeks)
- thyroid-stimulating hormone in uIU/mL(From enrollment to the end of treatment at 8 weeks)
- free thyroxine in pmol/L(From enrollment to the end of treatment at 8 weeks)
- free triiodothyronine in pmol/L(From enrollment to the end of treatment at 8 weeks)
- IL-1β in pg/mL(From enrollment to the end of treatment at 8 weeks)
- IL-6 in pg/mL(From enrollment to the end of treatment at 8 weeks)
- IL-10 in pg/mL(From enrollment to the end of treatment at 8 weeks)
- leptin in pg/mL(From enrollment to the end of treatment at 8 weeks)
- adiponectin in µg/mL(From enrollment to the end of treatment at 8 weeks)
- Hardness of liver in kPa(From enrollment to the end of treatment at 8 weeks)
- Controlled Attenuation Parameter in dB/m(From enrollment to the end of treatment at 8 weeks)
- Alpha diversity (Shannon index, Chao1)(From enrollment to the end of treatment at 8 weeks)
- Beta diversity (Bray-Curtis dissimilarity)(From enrollment to the end of treatment at 8 weeks)
- Relative abundance of specific taxa (e.g., Firmicutes/Bacteroidetes ratio)(From enrollment to the end of treatment at 8 weeks)
- Predicted functional pathways (via metagenomic analysis)(From enrollment to the end of treatment at 8 weeks)
- 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)
- basal metabolic rate in kcal(From enrollment to the end of treatment at 8 weeks)
- skeletal muscle mass in kilograms(From enrollment to the end of treatment at 8 weeks)
- blood pressure in mmHg(From enrollment to the end of treatment at 8 weeks)
- waist circumference in millimeters(From enrollment to the end of treatment at 8 weeks)
- hip circumference in millimeters(From enrollment to the end of treatment at 8 weeks)
- upper arm circumference in millimeters(From enrollment to the end of treatment at 8 weeks)
- left hand grip strength in pound-force(From enrollment to the end of treatment at 8 weeks)
研究者
Cui Mingxuan
Principal Investigator
Peking University People's Hospital
研究点 (2)
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