The Effect of an Alginate Based Beverage on Weight Loss

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity, Type 2 Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Alginate beverage
* Dietary Supplement: Control beverage


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alginate based beverage<br> | Dietary Supplement: Alginate beverage<br>* The dosage is 3x500ml daily<br>* Other names: Protanal;|
| Placebo Comparator: Control beverage<br> | Dietary Supplement: Control beverage<br>* The dosage is 3x500ml daily<br>* Other names: Maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 12 Weeks | 

Secondary Outcome Measures

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