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

October 29, 2010 updated by: University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Frederiksberg, Copenhagen, Denmark, 1958
        • Department of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Alginate based beverage
Dietary supplement: Alginate beverage
The dosage is 3x500ml daily
Other Names:
  • Protanal
PLACEBO_COMPARATOR: Control beverage
Dietary supplement: Control beverage
The dosage is 3x500ml daily
Other Names:
  • Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 12 weeks
12 weeks
Risk markers for type 2 diabetes
Time Frame: 12 weeks
12 weeks
Risk markers for cardiovascular disease
Time Frame: 12 Weeks
12 Weeks
Body composition
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Arne Astrup, Prof. MD., Department of Human Nutrtion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (ESTIMATE)

November 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2010

Last Update Submitted That Met QC Criteria

October 29, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B272
  • Scientific Ethical Committee (REGISTRY: H-2-2009-155)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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