Effect of Fermented Dietary Fiber and Probiotics on the Intervention of Overweight/Obese Patients With Impaired Glucose Regulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- fasting blood glucose
研究概览
简要总结
This study aims to investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals.
详细描述
Impaired glucose regulation (IGR), encompassing impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), represents a crucial stage in the progression to type 2 diabetes. Characterized by a state of compensatory glucose dysmetabolism, IGR is closely linked to overweight/obesity and can be reversed through lifestyle interventions. Timely intervention during this stage can promote weight loss, delay or prevent the onset and development of diabetes, and reduce the risk of cardiovascular diseases, chronic kidney disease, and all-cause mortality.
Current treatment approaches for overweight/obese IGR patients include dietary and physical activity modifications, pharmacotherapy, and bariatric surgery. However, individual responses to these interventions vary considerably. Dietary fiber, essential for maintaining normal gastrointestinal function, has been associated with an increased risk of various diseases, including colorectal cancer, cardiovascular diseases, obesity, metabolic syndrome, and type 2 diabetes, when consumed in inadequate amounts. Conversely, the gut microbiota plays a pivotal role in diabetes development and progression. Probiotics, potentially through the stimulation of short-chain fatty acid production and the induction of gut hormone secretion that influences blood glucose levels, may exert beneficial effects by enhancing immune modulation, increasing anti-inflammatory cytokine production, reducing intestinal permeability, and mitigating oxidative stress.
Therefore, this study aims to investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Meet the criteria for impaired glucose regulation according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)":
- •IFG: Fasting blood glucose ≥ 6.1 mmol/L and < 7.0 mmol/L IGT: 2-hour postprandial glucose ≥ 7.8 mmol/L and < 11.1 mmol/L
- •Meet the Asia-Pacific criteria for overweight and obesity: 23 kg/m2 ≤ BMI
- •Signed informed consent
排除标准
- •Patients diagnosed with diabetes or currently undergoing diabetes treatment
- •Patients who have received weight loss medication or surgery in the past 3 months
- •Patients who are taking corticosteroids or thyroid hormones
- •Patients with secondary obesity caused by endocrine, genetic, metabolic, or central nervous system diseases
- •Patients with severe liver function or abnormal kidney function
- •Patients with diseases that affect food digestion and absorption
- •Patients with cardiovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy, etc.
- •Patients with active tuberculosis, AIDS, and other infectious diseases
- •Pregnant or breastfeeding women
- •Patients with limb disabilities or other conditions that the clinical investigator deems inappropriate for participation in the study.
结局指标
主要结局
fasting blood glucose
时间窗: Baseline and after 8-week intervention
fasting blood glucose after an overnight fast
2-hour postprandial blood glucose
时间窗: Baseline and after 8-week intervention
2-hour postprandial blood glucose after 75g Glucose Tolerance Test
次要结局
- body composition(Baseline; after 4-week intervention; after 8-week intervention)
- Body weight(Baseline; after 4-week intervention; after 8-week intervention)
- Lipid profile(Baseline and after 8-week intervention)