跳至主要内容
临床试验/NCT01101633
NCT01101633已完成1 期

The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
appetite sensation

研究概览

简要总结

The aim of the study is to investigate the effects of a low-calorie alginate containing fruit flavored beverage on appetite and body weight development.

详细描述

The project consists of two different studies:

Study I: A randomised controled meal test study aimed at studying the acute effect of the alginate-containing beverage on appetite sensation and spontaneous calorie intake (and safety i.e. nausea, well-being etc) in normal to overweight healthy subjects. Here, a placebo beverage or the alginate-containing beverage will be administered as a pre-load before a standardised breakfast meal. Subjective appetite sensation will be measured with Visual Analogue Scale (VAS) every 30 minutes four up to 5 hours. An additional beverage will be administered prior to an ad libitum lunch meal, where spontaneous water and energy intake will be registered.

Study II: Secondly the aim is to study the effects of a daily intake of a placebo or alginate-containing beverage on body weight and composition in a randomised parallel intervention study of 12 weeks duration. A total of app. 50 obese healthy adults will receive a hypocaloric diet and be randomised to consume either placebo or alginate-containing beverage before each of the three main meals every day. The development in body weight and composition and blood pressure will be monitored and blood samples will be analysed for markers related to the risk of CVD and type 2 diabetes.

研究设计

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

入排标准

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

入选标准

  • Healthy men and women
  • Normal to slight overweight (BMI: 22-28 kg/m2)
  • 20-45 years of age

排除标准

  • Daily medicine use (oral contraceptives excluded)
  • Use of dietary supplements
  • Blood donation 3 months prior to the study
  • Hb<7.5 mmol/l
  • Chronic illnesses such as hyperlipidemia, diabetes and inflammatory diseases
  • Pregnancy or breastfeeding
  • Elite athletes (>10 hours hard exercise/week)
  • Vegetarians

结局指标

主要结局

appetite sensation

时间窗: 5 hours

次要结局

  • Plasma insulin and glucose level(5 hours)
  • Well being and adverse events(5 hours)
  • spontaneous calorie intake(5 hours)
  • gastric emptying(5 hours)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验

The Effect of Sodium Alginate on Appetite Sensation | 临床试验