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临床试验/NCT01615081
NCT01615081已完成不适用

The Acute Effect of Malt Extract Versus Sucrose on the Response of Glucose and Insulin, Subjective Appetite Sensations and ad Libitum Energy Intake

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年5月最近更新:
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
Acute 3-h changes from baseline in the postprandial concentration of glucose

研究概览

简要总结

Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with other composition and amount of carbohydrates could be of interest in order to decrease the glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a sweet flavor but contains a different composition and amount of carbohydrates together with a small amount of protein compared to sucrose. Malt extract may therefore be a better alternative than sucrose as a sweetener due to a lower increase and more sustained blood glucose level. This could be of interest in relation to diabetes and appetite regulation but this is yet to be investigated.

Thus the objective is to investigate the effect of malt extract vs. sucrose on:

  1. 3-hour change in the concentration of glucose and insulin
  2. 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)
  3. Ad libitum energy intake

Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • BMI: 18.5-24.9 kg/m2,
  • Weight stable (within +/- 3 kg) two months prior to study inclusion,
  • Non-smoking,
  • Nonathletic (< 10 h hard physical activity),

排除标准

  • BMI > 25 kg/m2,
  • Change in smoking status,
  • Daily or frequent use of medication,
  • Suffering from metabolic diseases,
  • Suffering from psychiatric diseases,
  • Suffering from any other clinical condition, which would make the subject unfit to participate in the study,
  • Hemoglobin < 7.5 mmol/l.
  • alcohol and drug abuse
  • blood donation, 3mo prior to the present study and during study participation

结局指标

主要结局

Acute 3-h changes from baseline in the postprandial concentration of glucose

时间窗: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day glucose is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake

Blood samples are taken prior to the test drink (baseline). After initiation of the test drink blood samples are collected at time 15, 30, 45, 60, 90, 120, 150, 180 minutes. Blood samples are analyzed for glucose.

次要结局

  • Acute 3-h changes from baseline in the postprandial concentration of insulin(Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day insulin is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake)
  • Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales(Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day appetite sensations are measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake)
  • Rating of the organoleptic quality of the test drinks(Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the test drink (approximately) time 5 minutes post intake) subjects will rate the test drink)
  • Rating of the organoleptic quality of the ad libitum meal(Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal)
  • Subjective appetite sensations (visual analogue scales) after ad libitum meal(Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. After completion of the ad libitum meal subjects will rate their subjective sensation of appetite (approx 3.5-h post intake of test drink))
  • change in body weight and composition (fat mass and fat free mass)(Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day body weight and composition is carried out prior to the test.)
  • ad libitum energy intake (EI)(Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. EI was measured 180 min after intake of the test drink)

研究者

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

AAstrup

Professor, Dr Med

University of Copenhagen

研究点 (2)

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