Effect of High Fiber and Sugar Free Biscuits in Diabetics Population
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The increase in diabetic population of the world is among the top ten causes of death; with diabetes always high on the list of causes of death. Diabetes is always relative to other major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal disease).
The eating habits and patterns of the diabetic patient are the main causes for poor glycemic control. In epidemiological studies, high fiber and low sugar dietary intake can significantly reduce the incidence of diabetes.
The purpose of this study is to investigate the effect of high fiber sugar-free biscuits in regulating blood glucose in pre-diabetic subjects.
The study will be conducted in three periods:
Period-I:
The recruitment of 60 pre-diabetic subjects:
Subjects of blood glucose levels "Impaired fasting glucose; IFG": fasting blood glucose ≧ 100 mg / dL, < 126 mg / dL or "Impaired glucose tolerance; IGT": 2 hours postprandial blood glucose ≧ 140mg/dL, < 200 mg/dL or clinically judged to be mild or moderate diabetes mellitus (HbA1c < 9%).
In addition to perform pre-test, all subjects also need to complete nutrition counseling and nutrition education .
All 60 subjects are randomly selected into two groups, Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group), Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group)
The period-II:
Duration: 8 weeks Group-1,30 subjects, (Placebo group, normal fiber and normal sugar biscuit group) , All 30 subjects consume 3 servings of Low-fiber, normal sugar biscuits daily.
Group-2, 30 subjects, (Experimental group, high fiber and sugar free biscuit group) All 30 subjects consume 3 serving of high-fiber, and sugar free biscuits (containing 16 grams of fiber) daily.
Post-period:
Blood samples of all 60 subjects will be collected to compare with period-I and period-II at the first day of 9th week.
Report of expectation:
The purpose of this study is to help the pre-diabetic subjects to reduce the risk of becoming diabetic through the consuming of high fiber and sugar free biscuits and nutrition education.
详细描述
The increase in diabetic population of the world, is among the top ten causes of death; with diabetes always a top cause of death. Diabetes is always related with other major causes of death, (e.g. in cerebral vascular disease, cardiovascular disease and renal disease).
The eating habits and patterns of diabetic patient are the main causes for poor glycemic control. In epidemiological studies, high fiber rand low sugar dietary intake can significantly reduce the incidence of diabetes.
The purpose of this study is to investigate the effect of high fiber sugar-free biscuits in regulating blood glucose in pre-diabetic subjects.
The study will be conducted in three periods:
Period-I:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •fasting blood glucose ≧100mg/dL and < 126mg/dL
- •Impaired glucose tolerance; IGT
- •HbA1c < 9%
排除标准
- •DM patients
结局指标
主要结局
HbA1c
时间窗: up to 8 weeks
The investigators expect the HbA1c will be greatly improved at the end of the study.
次要结局
- Insulin, Fasting Glucose,Ketone Body, Fructosamine.(8 weeks)