The Effect of Viscous Fibre on Glycemic Control in Individuals With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,394
- 试验地点
- 1
- 主要终点
- HbA1c (%)
研究概览
简要总结
Purpose of Study (The Effect of Viscous Fiber on Glycemic Control (VF & GC) in Individuals with Diabetes Mellitus.
According to the World Health Organization, about 347 million individuals are living with diabetes. (http://www.who.int/features/factfiles/diabetes/facts/en/, accessed on Nov. 23, 2015). Over the last decades, dietary fibers, namely dietary viscous fibers, have emerged as a nutrition component that may improve the postprandial glycemic response and hence aid in long term diabetes management. It is believed that supplementation with viscous fibers can control blood glucose by increasing viscosity of the gastric digesta, hence delaying gastric emptying and retarding entry of glucose into the bloodstream to result in a diminished postprandial rise in blood glucose. (Chutkan et al., 2012).
Currently, the evidence of the relationship between viscous fibers and diabetes is mixed. The systematic review method depends on combining data from many small studies in order to get a pooled estimate of the true effect. The purpose of this study is to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the fasting glycemic and insulinemic effect of viscous fiber supplementation. We hope the findings of this study will play a key role in developing the nutritional guidelines for individuals with diabetes mellitus.
详细描述
Background: Diet high in total dietary fiber content has been recommended for individuals with diabetes mellitus. However, the effect of supplementing diet with viscous fiber such as guar gum, beta glucan, psyllium, konjac, or other viscous fibers on glycemic and insulinemic outcomes in individuals with diabetes mellitus is still controversial.
Objective: To improve the evidence-based guidelines/ recommendations for diabetes mellitus, we will conduct a systematic review and meta-analysis on the effect of viscous fiber supplementation on glycemic control endpoints in individuals with diabetes mellitus.
Design: Cochrane handbook for systematic review of interventions will be used for planning and conducting this meta-analysis. The reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.
Data sources: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials will be searched using appropriate pre-determined search terms.
Study selection: All the included trials must be randomized, controlled, with duration of ≥ 3 weeks investigating the effect of supplementing diet with viscous fiber on glycemic control outcomes in individuals with diabetes mellitus. Acute studies, non-randomized, not appropriately controlled studies will be excluded. Both isocaloric and non-isocaloric will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Randomized Controlled Trials
- •Parallel or Crossover Design
- •Duration: ≥ 3 weeks
- •Food/ Supplements.
- •Soluble Fibers include: B-Glucan, Guar Gum, Konjac, Pectin, Psyllium.
- •Diabetes Biomarkers include: Fasting Blood Glucose, Fasting Insulin, Fructosamine, and HbA1c.
排除标准
- 未提供
结局指标
主要结局
HbA1c (%)
时间窗: 3 weeks
次要结局
- HOMA-IR (mU/mmol/l)(≥ 3 weeks)
- Fasting Blood Insulin (pmol/l)(≥ 3 weeks)
- Fructosamine (mmol/l)(≥ 3 weeks)
- Fasting Blood Glucose (mmol/l)(≥ 3 weeks)