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