Obesity Clinical Trial
Official title:
The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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