The Effect of Sodium Alginate on Appetite Sensation (B247Algobes)

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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

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


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

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

Primary Outcome Measures :

appetite sensation [ Time Frame: 5 hours ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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


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):

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.


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
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:


Overweight Body Weight Signs and Symptoms Alginic acid Hemostatics	Coagulants Radiation-Protective Agents Protective Agents Physiological Effects of Drugs

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