The Effect of an Alginate Based Beverage on Weight Loss

Obesity Clinical Trial

— ALGOBES  

Official title:

Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231178
• Other study ID #: B272
• Secondary ID: Scientific Ethic
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: October 29, 2010
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2010
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Alginate beverage
The dosage is 3x500ml daily
• Control beverage
The dosage is 3x500ml daily

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		12 Weeks	No
Secondary	Blood pressure		12 weeks	Yes
Secondary	Risk markers for type 2 diabetes		12 weeks	No
Secondary	Risk markers for cardiovascular disease		12 Weeks	No
Secondary	Body composition		12 Weeks	No