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临床试验/NCT04571866
NCT04571866已完成不适用

The Effect of Dietary Fiber-enriched Bread on Gastric Emptying and Postprandial Glucose Levels

University of Bergen2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Difference in gastric emptying (antral area, cm2) )

研究概览

简要总结

The rate of gastric emptying is proposed to be one of the major determinants of postprandial glycemia. A slower gastric emptying will thus result in a less pronounced rise in blood glucose, which is especially desirable in diabetes care as it will highly influence the overall glycemic control. The present study aims to investigate the rate of gastric emptying and postprandial blood glucose levels in response to the intake of bread with different dietary fiber-content. Though bread is one of the major sources of dietary carbohydrates in Central- and Northern Europe, the mechanism and the metabolic effects of bread consumption, however, is investigated in a limited number of studies.

详细描述

The rate of gastric emptying is related to small intestinal motility and absorption of carbohydrates, and it is one of the major determinants of postprandial glycemia. A slower rate of gastric emptying will thus result in a less pronounced rise in blood glucose. Especially in diabetes care, reduced gastric emptying is desirable because of its effect on the rise of postprandial blood glucose, which again highly influences the overall glycemic control.

Bread is one of the most eaten food items in Central- and Northern Europe, being one of the major sources of dietary carbohydrate intake. In addition, bread often contains a diverse range of dietary fiber. The effect on gastric emptying and the amount of dietary carbohydrates absorbed in the small intestine depends on the overall meal composition, the degree of processing, and the type of dietary fiber, e.g., viscous or non-viscous. The oat-derived dietary fiber beta-glucan may have favorable properties in this regard as adding beta-glucan to a meal has been shown to slow down the rate of gastric emptying. However, studies investigating the effect of beta-glucan on gastric emptying are scarce.

For assessment of gastric emptying, scintigraphy is seen as the "gold standard" as the method readily can discriminate between gastric emptying and absorption of glucose in the small intestine. However, this method is not often used due to its invasive nature and radiation. High-resolution real-time ultrasonography is now the most preferred method and regarded as a new "gold standard", proving good inter- and intra-observer agreement. Compared to scintigraphy, ultrasound is a safe and non-invasive procedure widely available in clinical settings.

Objectives

To establish whether a wheat bread with an optimized content of beta-glucan has a different effect on gastric emptying, satiety, and postprandial glycemia compared to control bread.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 18-40 years
  • BMI: 18.5-30 kg/m2

排除标准

  • Celiac disease, non-celiac gluten sensitivity or wheat allergy and intolerance
  • Use of medication that can affect gastric emptying
  • Gastroparesis
  • Gastrointestinal diseases
  • Gastrointestinal surgery including bariatric surgery
  • Chronic alcohol abuse
  • Current smoker
  • Pregnant or lactating women
  • Diabetes mellitus type 1 and 2
  • Anorexia nervosa or bulimia nervosa

结局指标

主要结局

Difference in gastric emptying (antral area, cm2) )

时间窗: 2 hours

Differences in antral area (cm2) at different time points after ingestion of standardised meals. The antral area is measured by real-time ultrasonography.

次要结局

  • Satiety hormones(2 hours)
  • Subjective satiety(2 hours)
  • Postprandial blood glucose(2 hours)
  • Insulin(2 hours)

研究者

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

Jutta Dierkes

Professor

University of Bergen

研究点 (2)

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