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The Effect of an Alginate Based Beverage on Weight Loss (ALGOBES)

Primary Purpose

Obesity, Type 2 Diabetes, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Alginate beverage
Control beverage
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy men and women
  • Overweight to obese (BMI 28-45 kg/m2)

Exclusion Criteria:

  • Chronic diseases including:liver and kidney disease, including P-Alanine aminotransferase (ALT), P-aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), creatinine kinase and P-lactate dehydrogenase (LD)> 2.0 times the upper limit of normal (ULN) (measured at the screening at the Department of Human Nutrition)
  • systemic infections and metabolic diseases that can interfere with energy balance,
  • diabetes or fasting blood glucose concentration> 7.0 mM, cardiovascular disease, systolic blood pressure ≥ 160 and / or a diastolic blood pressure ≥ 100 mmHg, hyperlipidemia (total cholesterol> 6.5 mM and triglycerides> 5.0 mM) (measured by the screening at the Department of Human Nutrition)
  • Food allergies
  • Psychiatric disorders and any clinical condition that makes the person unfit to participate in the experiment
  • Use of dietary supplements (during the experimental period and 3 months before study start)
  • Provision of blood for example. of donation or other scientific studies (during the trial and 3 months before study start) and hemoglobin <7.5 mmol / l (measured at the screening at the Department of Human Nutrition)
  • Smoking (throughout the trial and 6 months before study start)
  • Elite Athletes (> 10 hours strenuous exercise per week, self-reported)
  • Women who are pregnant or breastfeeding, and post-menustruelle (self reported)

Sites / Locations

  • Department of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alginate based beverage

Control beverage

Arm Description

Outcomes

Primary Outcome Measures

Body weight

Secondary Outcome Measures

Blood pressure
Risk markers for type 2 diabetes
Risk markers for cardiovascular disease
Body composition

Full Information

First Posted
April 8, 2010
Last Updated
October 29, 2010
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01231178
Brief Title
The Effect of an Alginate Based Beverage on Weight Loss
Acronym
ALGOBES
Official Title
Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The project aims to examine the efficacy of a 12-week intake of alginate based ready to drink supplement on development in body weight and body composition, and risk markers for type-2 diabetes and cardiovascular disease in obese subjects.
Detailed Description
The study consists of a parallel RCT with 96 overweight/obese subjects enrolled into two treatment arms: placebo or active for 12 weeks. They will undergo examination at time points 0 and 12 weeks where a DXA scan will be performed to assess body composition and a fasting blood sample will be taken. At time points 0, 2, 4, 6, 8, 10 and 12 weeks their weight and waist circumference and number of test products not consumed will be recorded. In addition all subjects receive dietary counselling during the 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes, Cardiovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alginate based beverage
Arm Type
Active Comparator
Arm Title
Control beverage
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Alginate beverage
Other Intervention Name(s)
Protanal
Intervention Description
The dosage is 3x500ml daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Control beverage
Other Intervention Name(s)
Maltodextrin
Intervention Description
The dosage is 3x500ml daily
Primary Outcome Measure Information:
Title
Body weight
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
12 weeks
Title
Risk markers for type 2 diabetes
Time Frame
12 weeks
Title
Risk markers for cardiovascular disease
Time Frame
12 Weeks
Title
Body composition
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men and women Overweight to obese (BMI 28-45 kg/m2) Exclusion Criteria: Chronic diseases including:liver and kidney disease, including P-Alanine aminotransferase (ALT), P-aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), creatinine kinase and P-lactate dehydrogenase (LD)> 2.0 times the upper limit of normal (ULN) (measured at the screening at the Department of Human Nutrition) systemic infections and metabolic diseases that can interfere with energy balance, diabetes or fasting blood glucose concentration> 7.0 mM, cardiovascular disease, systolic blood pressure ≥ 160 and / or a diastolic blood pressure ≥ 100 mmHg, hyperlipidemia (total cholesterol> 6.5 mM and triglycerides> 5.0 mM) (measured by the screening at the Department of Human Nutrition) Food allergies Psychiatric disorders and any clinical condition that makes the person unfit to participate in the experiment Use of dietary supplements (during the experimental period and 3 months before study start) Provision of blood for example. of donation or other scientific studies (during the trial and 3 months before study start) and hemoglobin <7.5 mmol / l (measured at the screening at the Department of Human Nutrition) Smoking (throughout the trial and 6 months before study start) Elite Athletes (> 10 hours strenuous exercise per week, self-reported) Women who are pregnant or breastfeeding, and post-menustruelle (self reported)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Prof. MD.
Organizational Affiliation
Department of Human Nutrtion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition
City
Frederiksberg
State/Province
Copenhagen
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22648709
Citation
Georg Jensen M, Kristensen M, Astrup A. Effect of alginate supplementation on weight loss in obese subjects completing a 12-wk energy-restricted diet: a randomized controlled trial. Am J Clin Nutr. 2012 Jul;96(1):5-13. doi: 10.3945/ajcn.111.025312. Epub 2012 May 30.
Results Reference
derived

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The Effect of an Alginate Based Beverage on Weight Loss

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