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
  Purpose

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 Intervention
Obesity
Type 2 Diabetes
Cardiovascular Disease
Dietary Supplement: Alginate beverage
Dietary Supplement: Control beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Body weight [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 96
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231178

Locations
Denmark
Department of Human Nutrition
Frederiksberg, Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Arne Astrup, Prof. MD. Department of Human Nutrtion
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Arne Astrup, MD, Head of Department, Department of Human Nutrition
ClinicalTrials.gov Identifier: NCT01231178     History of Changes
Other Study ID Numbers: B272, Scientific Ethical Committee
Study First Received: April 8, 2010
Last Updated: October 29, 2010
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Alginic acid
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014