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临床试验/NCT02735889
NCT02735889已完成不适用

The Effect of Different Levels of Carbonation in Drinks on Glycemic Response, Gastric Emptying, Satiety and Energy Intake

Clinical Nutrition Research Centre, Singapore2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Changes in blood glucose concentrations in capillary blood using Hemocue

研究概览

简要总结

The objective of this study is to compare the effect of different levels of carbonation isocaloric beverages on glycemic response (using protocol based on standardized glycemic index testing methodology), gastric emptying and satiety. It is hypothesized that carbon dioxide will delay gastric emptying, and in turn, attenuate glycemic response and enhance satiety. The use of a non-nutrient (gas) in improving glycemic response and satiety would have important health implications for the beverage industry.

详细描述

15-20 healthy subjects will be recruited for the study by means of advertisements, flyers and personal communications.

A randomized, cross-over design experiment with three treatments will be carried out. Three different beverages will be prepared:- No carbonation (NC): Potable water + sugar- Low carbonation (LC): Potable water + sugar + little CO2- High carbonation (HC): Potable water + sugar+ high CO2.

The outcome measures assessed will be glycemic response, gastric emptying and satiety. Glycemic response will be measured by taking capillary blood samples (<5ul) by fingerpricking with one-time use sterilized lancets. Gastric emptying will be assessed by ultrasonography methodology developed by Okabe et al, 2015. Satiety will be measured using electronic visual analogue scales assessing hunger, fullness, desire to eat, prospective consumption and thirst. In addition, participants will be asked to rate the level of effervescence of beverage, sweetness of beverage, amount of beverage consumed, as well as how pleasant the beverage was immediately after drinking of test beverage. Feelings of bloatedness will be assessed using electronic visual analogue scales administered at 0, 15, 30, 45, 60, 90,120 min from drinking of test beverage. At the end of the test session, ad libitum lunch will be served, and the amount of food and drinks consumed will be measured (by weight difference before and after serving).

研究设计

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

入排标准

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

入选标准

  • Healthy adult
  • Aged between 21 - 40 years old
  • BMI between 18.0-30.0 kg/m2
  • Blood pressure < 140/80 mmHg
  • Fasting blood glucose < 6.0mmol/L
  • Fasting blood glucose < 6.0mmol/L

排除标准

  • Are a smoker
  • Have symptoms or medical history of gastrointestinal, cardiovascular, diabetes, cancer or other illnesses/diseases/conditions that could affect gastric motility and appetite
  • Are on prescription medication
  • Had a major medical or surgical event requiring hospitalization within the preceding 3 months.
  • Are taking part in other clinical trials concurrently
  • Are taking part in sports at competitive/endurance levels
  • Have a score equal or greater than 3.7 for restrained eating in Dutch Eating Behaviour Questionnaire.
  • Have special dietary requirements or food allergies.

结局指标

主要结局

Changes in blood glucose concentrations in capillary blood using Hemocue

时间窗: 0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage

Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120 minutes using a Hemocue system (HemoCue Glucose 201 RT Systems)

次要结局

  • Satiety(0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage)
  • Amount of food consumed(2.5 hr subsequent to beverage consumption)
  • Energy intake(2.5 hr subsequent to beverage consumption)
  • Changes in cross sectional area of antrum imaged using ultrasound(0, 5, 10, 20, 30, 40, 50, 60, 90, 120 after drinking test beverage)

研究者

发起方
Clinical Nutrition Research Centre, Singapore
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

JeyaKumar Henry

Principal Investigator

Clinical Nutrition Research Centre, Singapore

研究点 (2)

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