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临床试验/NCT03630445
NCT03630445已完成不适用

Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rate Suggests Activation of Ileal Brake Response

Purdue University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年6月2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
20
试验地点
2
主要终点
Appetite ratings (Visual Analog Scale, VAS)

研究概览

简要总结

The ileal brake is a feedback mechanism controlling stomach-mediated transit of a meal, for which gastric emptying can be used as an indicator. Previously, slowly digestible carbohydrates (SDCs) were shown to activate the ileal brake in a rat model; the current research aimed to determine the effect of common SDCs in humans.

详细描述

Diets containing slowly digestible carbohydrates (SDCs), in the form of starch-entrapped microspheres that digest into the ileum, were previously shown to reduce food intake in a diet-induced obese rat model by activating the gut-brain axis. These results suggested that SDCs trigger the ileal brake, which is a feedback mechanism controlling stomach-mediated transit of a meal. The ileal brake is characterized by delayed gastric emptying rate and increased satiety. The goal of this work was to determine if common SDCs trigger the ileal brake in humans, using gastric emptying rate as a proxy indicator. In a human study, SDCs were delivered through a semi-solid yogurt matrix, and gastric half-emptying time and postprandial glycemic response were assessed. The study was a five-arm, double-blind, crossover design with a one-week washout period between treatments (n=20, 9 females, 11 males). Four different carbohydrate ingredients (SDCs: isomalto-oligosaccharides (IMO), Xtend® sucromalt, and raw corn starch; and non-SDC: maltodextrin) were incorporated individually, or in combination, into yogurt products matched in energy density and viscosity. Participants consumed 300 g test meals of yogurt formulated with one or a combination of the carbohydrate ingredients after an overnight fast. Gastric emptying rates and glycemic response were measured using a 13C-labeled octanoic acid breath test and continuous glucose monitors, respectively. Glucose readings were continuously monitored 24 h prior to and 48 h after test meal consumption, and breath samples were collected for a 4 h period following test meal consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 18.5 - 25 kg/m2
  • Stable weight for the past 3 months (i.e. +/- 2..5 kg)
  • Regular eating patterns, including breakfast consumption

排除标准

  • Gastrointestinal disease
  • Peri- or post-menopausal women
  • Celiac disease (yogurts may contain ingredients with wheat origin)
  • Allergies, including dairy, lactose, and gluten
  • Pregnant and lactating women
  • Following a weight reduction program or having followed one during the last 3 months
  • Acute or chronic disease
  • Alcohol consumption > 30 units/week
  • Hypertension
  • Previous bariatric surgery

结局指标

主要结局

Appetite ratings (Visual Analog Scale, VAS)

时间窗: Acute study; 4 hours of measurement after consumption of test food

Hunger and fullness scores were measured using a 10-cm scale (0 = weakest feeling of hunger or fullness and 10 = strongest feeling of hunger or fullness) after consumption of test food. Weaker feelings of hunger and stronger feelings of fullness indicate better outcomes.

Gastric emptying rate

时间窗: Acute study; 4 hours of measurement after consumption of test food

Breath test was performed using 13C-octanoic acid mixed into test meals

Glycemic response

时间窗: Acute study; 4 hours of measurement after consumption of test food

Blood glucose was measured using a continuous glucose monitor

次要结局

  • Breath hydrogen (fermentability)(Acute study; 4 hours of measurement after consumption of test food)

研究者

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

Bruce R. Hamaker

Distinguished Professor of Food Science

Purdue University

研究点 (2)

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