A Phase 1 interventional study of Alginate and Alginate in Obesity and Overweight, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-04-12.
Sponsored by University of Copenhagen · Phase 1, Interventional, and Treatment
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 20 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →University of Copenhagen is the lead sponsor of 465 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
500 ml beverage containing alginate (3%)
Dietary Supplement: Alginate
330 ml beverage containing alginate (3%)
Dietary Supplement: Alginate
500 ml beverage without alginate (placebo)
Dietary Supplement: Placebo
330 ml beverage without alginate (placebo)
Dietary Supplement: Placebo
Drug pages: Alginates · Alginic Acid
a 500 ml alginate beverage per meal test
Drug pages: Alginates · Alginic Acid
a 330 ml alginate beverage per meal test
a 500 ml placebo beverage per meal test
a 330 ml placebo beverage per meal test
appetite sensation
Time frame: 5 hours
Plasma insulin and glucose level
Time frame: 5 hours
Well being and adverse events
Time frame: 5 hours
gastric emptying
Time frame: 5 hours
spontaneous calorie intake
Time frame: 5 hours
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Alginates · Alginic Acid