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The Effect of Sodium Alginate on Appetite Sensation (B247Algobes)

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Alginate
Alginate
Placebo
Placebo
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Appetite, Energy intake, gastric emptying, well being, Body weight

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Human Nutrtion, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

500 ml beverage containing alginate (3%)

330 ml beverage containing alginate (3%)

500 ml beverage without alginate (placebo)

330 ml beverage without alginate (placebo)

Outcomes

Primary Outcome Measures

appetite sensation

Secondary Outcome Measures

Plasma insulin and glucose level
Well being and adverse events
gastric emptying
spontaneous calorie intake

Full Information

First Posted
August 25, 2009
Last Updated
April 9, 2010
Sponsor
University of Copenhagen
Collaborators
SBiotek
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1. Study Identification

Unique Protocol Identification Number
NCT01101633
Brief Title
The Effect of Sodium Alginate on Appetite Sensation
Acronym
B247Algobes
Official Title
The Effect of Sodium Alginate Containing Beverage on Appetite and Body Weight Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Copenhagen
Collaborators
SBiotek

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Appetite, Energy intake, gastric emptying, well being, Body weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
500 ml beverage containing alginate (3%)
Arm Title
2
Arm Type
Active Comparator
Arm Description
330 ml beverage containing alginate (3%)
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
500 ml beverage without alginate (placebo)
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
330 ml beverage without alginate (placebo)
Intervention Type
Dietary Supplement
Intervention Name(s)
Alginate
Intervention Description
a 500 ml alginate beverage per meal test
Intervention Type
Dietary Supplement
Intervention Name(s)
Alginate
Intervention Description
a 330 ml alginate beverage per meal test
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
a 500 ml placebo beverage per meal test
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
a 330 ml placebo beverage per meal test
Primary Outcome Measure Information:
Title
appetite sensation
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Plasma insulin and glucose level
Time Frame
5 hours
Title
Well being and adverse events
Time Frame
5 hours
Title
gastric emptying
Time Frame
5 hours
Title
spontaneous calorie intake
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Dr. Med
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrtion, University of Copenhagen
City
Frederiksberg
State/Province
Copenhagen
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21779093
Citation
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.
Results Reference
derived

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The Effect of Sodium Alginate on Appetite Sensation

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