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双盲、随机、对照、急性喂养等效性试验:小剂量果糖和阿洛酮糖对健康参与者餐后血糖代谢的催化作用:果糖和阿洛酮糖催化效应(FACE)试验。

A Double-Blind, Randomized Controlled, Acute Feeding Equivalence Trial of Small, Catalytic Doses of Fructose and Allulose on Postprandial Blood Glucose Metabolism in Healthy Participants: The Fructose and Allulose Catalytic Effects (FACE) Trial.

机构信息

Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Risk Factor Modification Centre, Toronto, ON M5C 2T2, Canada.

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON M5S 3E2, Canada.

出版信息

Nutrients. 2018 Jun 9;10(6):750. doi: 10.3390/nu10060750.

Abstract

UNLABELLED

Recent literature suggests that catalytic doses (≤10 g/meal or 36 g/day) of D-fructose and D-allulose may reduce postprandial blood glucose responses to carbohydrate loads in people with and without type 2 diabetes by inducing glycogen synthesis. To assess the effect of small single doses of fructose and allulose on postprandial blood glucose regulation in response to a 75 g-oral glucose tolerance test (75 g-OGTT) in healthy individuals, we conducted an acute randomized, crossover, equivalence trial in healthy adults. Each participant randomly received six treatments, separated by a minimum one-week washout. Treatments consisted of a 75 g-OGTT with the addition of fructose or allulose at 0 g (control), 5 g or 10 g. A standard 75 g-OGTT protocol was followed with blood samples at −30, 0, 30, 60, 90, 120 min. The primary outcome was the difference in plasma glucose incremental area under the curve (iAUC). A total of 27 participants underwent randomization with data available from 25 participants. Small doses of fructose or allulose did not show a significant effect on plasma glucose iAUC or other secondary markers of postprandial blood glucose regulation in response to a 75 g-OGTT in healthy individuals. These results were limited by the low power to detect a significant difference, owing to greater than expected intra-individual coefficient of variation (CV) in plasma glucose iAUC. Overall, we failed to confirm the catalytic effects of small doses of fructose and allulose in healthy individuals. Future trials may consider recruiting larger sample sizes of healthy individuals.

TRIAL REGISTRATION

clinicaltrials.gov identifier, NCT02459834.

摘要

目的

最近的文献表明,催化剂量(≤10 克/餐或 36 克/天)的 D-果糖和 D-塔格糖可能通过诱导肝醣合成,降低 2 型糖尿病和非糖尿病患者碳水化合物负荷后的血糖反应。为了评估小剂量果糖和塔格糖对健康个体口服 75 克葡萄糖耐量试验(75 g-OGTT)后餐后血糖调节的影响,我们在健康成年人中进行了一项急性随机、交叉、等效性试验。每个参与者随机接受六种治疗,每种治疗之间至少间隔一周洗脱期。治疗包括在 75 g-OGTT 中添加 0 g(对照)、5 g 或 10 g 的果糖或塔格糖。采用标准 75 g-OGTT 方案,在−30、0、30、60、90、120 分钟时采集血样。主要结局是血浆葡萄糖增量曲线下面积(iAUC)的差异。共有 27 名参与者接受随机分组,25 名参与者的数据可用。小剂量的果糖或塔格糖对健康个体口服 75 g-OGTT 后血浆葡萄糖 iAUC 或其他餐后血糖调节的次要标志物均无显著影响。由于血浆葡萄糖 iAUC 的个体内变异系数(CV)高于预期,因此检测差异的效力较低,这些结果受到限制。总的来说,我们未能在健康个体中证实小剂量果糖和塔格糖的催化作用。未来的试验可能需要招募更多的健康个体。

试验注册

临床试验.gov 标识符,NCT02459834。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba2b/6024645/ce38080f7cd8/nutrients-10-00750-g001.jpg

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