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

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01231178
First received: April 8, 2010
Last updated: October 29, 2010
Last verified: April 2010

April 8, 2010
October 29, 2010
February 2010
July 2010   (final data collection date for primary outcome measure)
Body weight [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01231178 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Risk markers for type 2 diabetes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Risk markers for cardiovascular disease [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of an Alginate Based Beverage on Weight Loss
Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Type 2 Diabetes
  • Cardiovascular Disease
  • Dietary Supplement: Alginate beverage
    The dosage is 3x500ml daily
    Other Name: Protanal
  • Dietary Supplement: Control beverage
    The dosage is 3x500ml daily
    Other Name: Maltodextrin
  • Active Comparator: Alginate based beverage
    Intervention: Dietary Supplement: Alginate beverage
  • Placebo Comparator: Control beverage
    Intervention: Dietary Supplement: Control beverage
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
July 2010
July 2010   (final data collection date for primary outcome measure)

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)
Both
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01231178
B272, Scientific Ethical Committee
No
Prof. Arne Astrup, MD, Head of Department, Department of Human Nutrition
University of Copenhagen
Not Provided
Principal Investigator: Arne Astrup, Prof. MD. Department of Human Nutrtion
University of Copenhagen
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP