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The Effect of Sodium Alginate on Appetite Sensation (B247Algobes)

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.
 
ClinicalTrials.gov Identifier: NCT01101633
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : April 12, 2010
Sponsor:
Collaborator:
SBiotek
Information provided by:
University of Copenhagen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Dietary Supplement: Alginate Dietary Supplement: Placebo Phase 1

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation
Study Start Date : February 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
500 ml beverage containing alginate (3%)
 Dietary Supplement: Alginate
a 500 ml alginate beverage per meal test
Active Comparator: 2
330 ml beverage containing alginate (3%)
 Dietary Supplement: Alginate
a 330 ml alginate beverage per meal test
Placebo Comparator: 3
500 ml beverage without alginate (placebo)
 Dietary Supplement: Placebo
a 500 ml placebo beverage per meal test
Placebo Comparator: 4
330 ml beverage without alginate (placebo)
 Dietary Supplement: Placebo
a 330 ml placebo beverage per meal test


Outcome Measures
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Primary Outcome Measures :
  1. appetite sensation [ Time Frame: 5 hours ]

Secondary Outcome Measures :
  1. Plasma insulin and glucose level [ Time Frame: 5 hours ]
  2. Well being and adverse events [ Time Frame: 5 hours ]
  3. gastric emptying [ Time Frame: 5 hours ]
  4. spontaneous calorie intake [ Time Frame: 5 hours ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101633


Locations
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Denmark
Department of Human Nutrtion, University of Copenhagen
Frederiksberg, Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
SBiotek
Investigators
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Principal Investigator: Arne Astrup, Dr. Med University of Copenhagen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arne Astrup, Prof. Dr. Med., Department of Human Nutrition
ClinicalTrials.gov Identifier: NCT01101633    
Other Study ID Numbers: H-C-2008-088
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: August 2009
Keywords provided by University of Copenhagen:
Appetite
Energy intake
gastric emptying
well being
Body weight
Additional relevant MeSH terms:
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Overweight
Body Weight