An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Glucose Metabolism and Insulin Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- plasma glucose 2 h after an oral glucose load
研究概览
简要总结
This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood glucose, gut microbiota and cardiovascular risk fators in subjects with hyperglycemia.
详细描述
Highland barley β-glucan belongs to the group of prebiotics and has been found to be associated with multiple health benefits. However, its protective role in subjects with hyperglycemia are remain unclear. This study aims to examine the effect of 8-week prebiotics supplementation on glucose management in subjects with hyperglycemia. By understanding the mechanism by which prebiotics exert the beneficial effects, we can better control the rising prevalence of hyperglycemia, which is a major risk factor for cardiovascular diseases.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 30-65 years old
- •Fasting venous plasma glucose ≥5.6mmol/L OR plasma glucose 2 h after an oral glucose load ≥7.8mmol/L OR glycosylated hemoglobin ≥5.7% OR newly diagnosed diabetes without hypoglycemic drugs using
- •BMI≥18 kg/ m2
排除标准
- •Receiving or have been treated with hypoglycemic drugs or insulin.
- •Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke.
- •Severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal OR GFR<30ml/min/1.73m2).
- •Autoimmune diseases or thyroid diseases.
- •Women who are pregnant, nursing, or prepare to give birth during the trail.
- •Malignant disease, infectious disease, inflammatory disease and advanced liver disease.
- •Mental or intellectual abnormalities, unable to sign informed consent.
- •Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit.
- •Received antibiotics, probiotics within 3 months before screening visit or throughout the trail.
- •Major operations were performed within six months of screening visit, or will be made during the trial.
- •Alcohol abuse (alcohol intake>60g/d for male and alcohol intake>40g/d for female)
结局指标
主要结局
plasma glucose 2 h after an oral glucose load
时间窗: baseline and after 8-week intervention
changes of plasma glucose levels 2 h after an oral glucose load
glycosylated hemoglobin
时间窗: baseline and after 8-week intervention
changes of glycosylated hemoglobin levels
fasting venous plasma glucose
时间窗: baseline and after 8-week intervention
changes of fasting venous plasma glucose levels
次要结局
- gut microbiota(baseline and after 8-week intervention)
- Matsuda index(baseline and after 8-week intervention)
- microbial metabolites(baseline and after 8-week intervention)
- flow-mediated dilation(baseline and after 8-week intervention)
研究者
Min Xia
Professor
Sun Yat-sen University