The Effect of Sodium Alginate on Appetite Sensation (B247Algobes)

April 9, 2010 updated by: University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Frederiksberg, Copenhagen, Denmark, 1958
        • Department of Human Nutrtion, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
500 ml beverage containing alginate (3%)
Dietary supplement: Alginate
a 500 ml alginate beverage per meal test
Dietary supplement: Alginate
a 330 ml alginate beverage per meal test
Active Comparator: 2
330 ml beverage containing alginate (3%)
Dietary supplement: Alginate
a 500 ml alginate beverage per meal test
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
Dietary supplement: Placebo
a 330 ml placebo beverage per meal test
Placebo Comparator: 4
330 ml beverage without alginate (placebo)
Dietary supplement: Placebo
a 500 ml placebo beverage per meal test
Dietary supplement: Placebo
a 330 ml placebo beverage per meal test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
appetite sensation
Time Frame: 5 hours
5 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma insulin and glucose level
Time Frame: 5 hours
5 hours
Well being and adverse events
Time Frame: 5 hours
5 hours
gastric emptying
Time Frame: 5 hours
5 hours
spontaneous calorie intake
Time Frame: 5 hours
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

SBiotek

Investigators

  • Principal Investigator: Arne Astrup, Dr. Med, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

April 9, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

April 12, 2010

Last Update Submitted That Met QC Criteria

April 9, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-C-2008-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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