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| Name | Class |
|---|---|
| SBiotek | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 500 ml beverage containing alginate (3%) |
|
| 2 | Active Comparator | 330 ml beverage containing alginate (3%) |
|
| 3 | Placebo Comparator | 500 ml beverage without alginate (placebo) |
|
| 4 | Placebo Comparator | 330 ml beverage without alginate (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alginate | Dietary Supplement | a 500 ml alginate beverage per meal test |
| |
| Measure | Description | Time Frame |
|---|---|---|
| appetite sensation | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma insulin and glucose level | 5 hours | |
| Well being and adverse events | 5 hours | |
| gastric emptying |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arne Astrup, Dr. Med | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrtion, University of Copenhagen | Frederiksberg | Copenhagen | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21779093 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000464 | Alginates |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Alginate |
| Dietary Supplement |
a 330 ml alginate beverage per meal test |
|
| Placebo | Dietary Supplement | a 500 ml placebo beverage per meal test |
|
| Placebo | Dietary Supplement | a 330 ml placebo beverage per meal test |
|
| 5 hours |
| spontaneous calorie intake | 5 hours |
| D013568 | Pathological Conditions, Signs and Symptoms |