Study Results
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Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2009-02-28
2009-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
500 ml beverage containing alginate (3%)
Alginate
a 500 ml alginate beverage per meal test
2
330 ml beverage containing alginate (3%)
Alginate
a 330 ml alginate beverage per meal test
3
500 ml beverage without alginate (placebo)
Placebo
a 500 ml placebo beverage per meal test
4
330 ml beverage without alginate (placebo)
Placebo
a 330 ml placebo beverage per meal test
Interventions
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Alginate
a 500 ml alginate beverage per meal test
Alginate
a 330 ml alginate beverage per meal test
Placebo
a 500 ml placebo beverage per meal test
Placebo
a 330 ml placebo beverage per meal test
Eligibility Criteria
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Inclusion Criteria
* Normal to slight overweight (BMI: 22-28 kg/m2)
* 20-45 years of age
Exclusion Criteria
* 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
20 Years
45 Years
ALL
Yes
Sponsors
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SBiotek
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Department of Human Nutrition
Principal Investigators
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Arne Astrup, Dr. Med
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Department of Human Nutrtion, University of Copenhagen
Frederiksberg, Copenhagen, Denmark
Countries
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References
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Georg Jensen M, Kristensen M, Belza A, Knudsen JC, Astrup A. Acute effect of alginate-based preload on satiety feelings, energy intake, and gastric emptying rate in healthy subjects. Obesity (Silver Spring). 2012 Sep;20(9):1851-8. doi: 10.1038/oby.2011.232. Epub 2011 Jul 21.
Other Identifiers
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H-C-2008-088
Identifier Type: -
Identifier Source: org_study_id
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