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The Effect of Sodium Alginate on Appetite Sensation (B247Algobes)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101633
First Posted: April 12, 2010
Last Update Posted: April 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SBiotek
Information provided by:
University of Copenhagen
August 25, 2009
April 12, 2010
April 12, 2010
February 2009
October 2009   (Final data collection date for primary outcome measure)
appetite sensation [ Time Frame: 5 hours ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Sodium Alginate on Appetite Sensation
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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • Dietary Supplement: Alginate
    a 500 ml alginate beverage per meal test
  • Dietary Supplement: Alginate
    a 330 ml alginate beverage per meal test
  • Dietary Supplement: Placebo
    a 500 ml placebo beverage per meal test
  • Dietary Supplement: Placebo
    a 330 ml placebo beverage per meal test
  • Active Comparator: 1
    500 ml beverage containing alginate (3%)
    Intervention: Dietary Supplement: Alginate
  • Active Comparator: 2
    330 ml beverage containing alginate (3%)
    Intervention: Dietary Supplement: Alginate
  • Placebo Comparator: 3
    500 ml beverage without alginate (placebo)
    Intervention: Dietary Supplement: Placebo
  • Placebo Comparator: 4
    330 ml beverage without alginate (placebo)
    Intervention: Dietary Supplement: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2009
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy men and women
  • Normal to slight overweight (BMI: 22-28 kg/m2)
  • 20-45 years of age

Exclusion Criteria:

  • Smoking
  • 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
Sexes Eligible for Study: All
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01101633
H-C-2008-088
No
Not Provided
Not Provided
Arne Astrup, Prof. Dr. Med., Department of Human Nutrition
University of Copenhagen
SBiotek
Principal Investigator: Arne Astrup, Dr. Med University of Copenhagen
University of Copenhagen
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP