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临床试验/NCT02960373
NCT02960373Unknown不适用

Dried Fruit as a Means for Lowering the Glycemic Response to High Glycemic Index-carbohydrate Foods

University of Toronto2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Glycemic index (GI)

研究概览

简要总结

Dried fruits show promising potential for the management of blood glucose. Previous trials have reported beneficial effects of raisins on post-prandial glucose and insulin responses in healthy individuals when compared with white bread. However, to date there is limited data evaluating the potential beneficial effects of other dried fruits (i.e. sultanas, dates and apricots). It is also unclear whether dried fruits can be used to lower the postprandial glycemic responses to high-GI carbohydrate foods by either displacing available carbohydrate (displacement effect) or providing 'catalytic' doses of fructose ('catalytic' fructose effect). To address these questions, the investigators propose to assess the GI of 4 common types of dried fruit (raisins, sultanas, dates, apricots) (GI effect) and their ability to decrease the postprandial glycemic response to white bread by either partially displacing available carbohydrate (displacement effect) or by providing a 'catalytic' dose of fructose ('catalytic' fructose effect).

详细描述

BACKGROUND:

All studies assessing the glycemic index (GI) of traditional dried fruit show that they are low-to-moderate GI foods and that the insulin response is proportional to their GI. A recent study compared the glycemic response of two doses of raisins (28 and 69g) versus white bread showing that both doses of raisins significantly reduced post-prandial glucose and insulin levels compared with white bread. However, the effect of combining dried fruits with high-GI carbohydrate foods has never been addressed. The potential impact of combining nuts (i.e. pistachios) and high-GI carbohydrate foods has already analyzed with positive results. The investigators found that a dose of 56g of pistachios consumed alone had a minimal effect on post-prandial glycemia, but when taken with a high-carbohydrate meal attenuated the relative glycemic response. Although foods with high fibre content generally have a low-GI, other factors also contribute to a food's glycemic response. Factors thought to contribute to the glycemic response of dried fruits include the viscous texture when chewed; their whole food matrix; the presence of phenolic compounds and organic acids and the type of sugar present. In the case of dried fruit, about 50% fructose (low-GI) is present. Therefore, the consumption of dried fruit with high-carbohydrate foods may lead to glycemic control benefits by lowering the GI of a food. In addition to potentially lowering the GI of a food, dried fruits may also affect glycemic control by providing 'catalytic' doses of fructose. Fructose, through its metabolite fructose-1-P, has been shown to have "catalytic" effects on hepatic glucose metabolism by inducing glucokinase activity in hepatocytes. In specific, fructose-1-P displaces fructose-6-P from glucokinase's regulatory binding protein in the nucleus causing the release of glucokinase from its regulatory protein, allowing it to translocate to the cytosol, resulting in increased phosphorylation of glucose. Infusion studies in humans have shown that this mechanism relates to a ~30% decrease in hepatic glucose output under hyperglycemic conditions in participants with type 2 diabetes (T2D) and a ~3-fold increase in glycogen synthesis by C13-nuclear magnetic resonance (NMR) spectroscopy under euglycemic conditions in healthy people. Clinical translation of these findings has proven promising. Catalytic doses of fructose at 7.5g and 10g have been shown to decrease the postprandial glycemic responses to high GI meals (oral glucose, maltodextrins, or mashed potatoes) from ~15-30% in healthy participants and those with pre-diabetes or diabetes . These acute effects have been shown to be sustainable over the longer term as well. Systematic reviews and meta-analyses of controlled feeding trials have shown that small doses of fructose in exchange for other carbohydrates decreases HbA1c at a level which exceeds the clinically meaningful threshold of 0.3% proposed by the Federal Drug Administration (FDA) for the development of new oral anti-hyperglycemic agents. Therefore, the consumption of dried fruit with high-carbohydrate foods may lead to glycemic control benefits by acting as a vehicle for 'catalytic' doses of fructose.

OBJECTIVES:

To investigate the effect of using dried fruit to modify the glycemic response of high GI foods, the investigators propose the following 3 objectives:

  1. To assess the GI of 4 common types of dried fruit (raisins, sultanas, dates, apricots) (GI effect)
  2. To assess the ability of the 4 common types of dried fruit (raisins, sultanas, dates, apricots) to decrease the postprandial glycemic response to white bread by displacing half of the available carbohydrate (displacement effect)
  3. To assess the ability of the 4 common types of dried fruit (raisins, sultanas, dates, apricots) to decrease the postprandial glycemic response to white bread by providing a 'catalytic' dose (7.5g) of fructose ('catalytic' fructose effect)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult males and/or non-pregnant females aged 18-75 years and in good health

排除标准

  • Age less than 18 years or greater than 75 years
  • BMI<18.5kg/m2 or >30kg/m2
  • Known history of HIV, liver disease, kidney disease, thyroid disease, diabetes, heart disease or or any other major illnesses that may affect carbohydrate metabolism
  • Subjects using medications which might, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
  • Subjects who cannot or will not comply with the experimental procedures or do not follow the clinic's safety guidelines.

结局指标

主要结局

Glycemic index (GI)

时间窗: Up to 120min

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Sievenpiper

Associate Professor, Staff Physician, Scientist

University of Toronto

研究点 (2)

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