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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231178
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : November 1, 2010
Information provided by:
University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Cardiovascular Disease Dietary Supplement: Alginate beverage Dietary Supplement: Control beverage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Alginate based beverage Dietary Supplement: Alginate beverage
The dosage is 3x500ml daily
Other Name: Protanal

Placebo Comparator: Control beverage Dietary Supplement: Control beverage
The dosage is 3x500ml daily
Other Name: Maltodextrin

Primary Outcome Measures :
  1. Body weight [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 12 weeks ]
  2. Risk markers for type 2 diabetes [ Time Frame: 12 weeks ]
  3. Risk markers for cardiovascular disease [ Time Frame: 12 Weeks ]
  4. Body composition [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

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 identifier (NCT number): NCT01231178

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Department of Human Nutrition
Frederiksberg, Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
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Principal Investigator: Arne Astrup, Prof. MD. Department of Human Nutrtion
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Arne Astrup, MD, Head of Department, Department of Human Nutrition Identifier: NCT01231178    
Other Study ID Numbers: B272
Scientific Ethical Committee ( Registry Identifier: H-2-2009-155 )
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases