The Effect of Sodium Alginate on Appetite Sensation

Obesity Clinical Trial

— B247Algobes  

Official title:

The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101633
• Other study ID #: H-C-2008-088
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2009
• Last updated: April 9, 2010
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Alginate
a 500 ml alginate beverage per meal test
• Alginate
a 330 ml alginate beverage per meal test
• Placebo
a 500 ml placebo beverage per meal test
• Placebo
a 330 ml placebo beverage per meal test

Locations

Country	Name	City	State
Denmark	Department of Human Nutrtion, University of Copenhagen	Frederiksberg	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	SBiotek

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	appetite sensation		5 hours	Yes
Secondary	Plasma insulin and glucose level		5 hours	Yes
Secondary	Well being and adverse events		5 hours	Yes
Secondary	gastric emptying		5 hours	Yes
Secondary	spontaneous calorie intake		5 hours	No