Status:
COMPLETED
The Effect of an Alginate Based Beverage on Weight Loss
Lead Sponsor:
University of Copenhagen
Conditions:
Obesity
Type 2 Diabetes
Eligibility:
All Genders
20-55 years
Phase:
NA
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 ca...
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 whe...
Eligibility Criteria
Inclusion
- Healthy men and women
- Overweight to obese (BMI 28-45 kg/m2)
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01231178
Start Date
February 1 2010
End Date
July 1 2010
Last Update
November 1 2010
Active Locations (1)
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1
Department of Human Nutrition
Frederiksberg, Copenhagen, Denmark, 1958