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The Effect of Sodium Alginate on Appetite Sensation (B247Algobes)

This study has been completed.
Sponsor:
Collaborator:
SBiotek
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01101633
First received: August 25, 2009
Last updated: April 9, 2010
Last verified: August 2009
History of Changes
  Purpose
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 Intervention Phase
Obesity
Overweight
 Dietary Supplement: Alginate
Dietary Supplement: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation

Resource links provided by NLM:

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • appetite sensation [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma insulin and glucose level [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
  • Well being and adverse events [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
  • gastric emptying [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
  • spontaneous calorie intake [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
Enrollment: 20
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101633

Locations
Denmark
Department of Human Nutrtion, University of Copenhagen
Frederiksberg, Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
SBiotek
Investigators
Principal Investigator: Arne Astrup, Dr. Med University of Copenhagen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arne Astrup, Prof. Dr. Med., Department of Human Nutrition
ClinicalTrials.gov Identifier: NCT01101633     History of Changes
Other Study ID Numbers: H-C-2008-088 
Study First Received: August 25, 2009
Last Updated: April 9, 2010
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
Appetite
Energy intake
gastric emptying
well being
Body weight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Alginic acid
Hemostatics
 Coagulants
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016