Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota

Обзор

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.

Вмешательства

• Пищевая добавка barley green
  Oral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day

Первичные конечные точки

• visceral fat area in cm2 [Срок оценки: From enrollment to the end of treatment at 8 weeks.]

Вторичные конечные точки (12)

• height in centimeters [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• weight in kilograms [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• BMI in kg/m^2 [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• body fat rate in % [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• muscle mass in kilograms [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• basal metabolic rate in kcal [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• skeletal muscle mass in kilograms [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• blood pressure in mmHg [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• waist circumference in millimeters [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• hip circumference in millimeters [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• upper arm circumference in millimeters [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• left hand grip strength in pound-force [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06886048 · 2024PHB574-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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