Clinical trial NCT01231178: The Effect of an Alginate Based Beverage on Weight Loss
Official title: Alginate Fibers Effect on Body Weight and Risk Markers for Type 2 Diabetes and Cardiovascular Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Cardiovascular Disease
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 cardiovascular disease in obese subjects.

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 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)

Primary outcomes:
measure: Body weight
timeFrame: 12 Weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 12 weeks
measure: Risk markers for type 2 diabetes
timeFrame: 12 weeks
measure: Risk markers for cardiovascular disease
timeFrame: 12 Weeks
measure: Body composition
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
state: Copenhagen
Study officials:
affiliation: Department of Human Nutrtion
name: Arne Astrup, Prof. MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Georg Jensen M, Kristensen M, Astrup A. Effect of alginate supplementation on weight loss in obese subjects completing a 12-wk energy-restricted diet: a randomized controlled trial. Am J Clin Nutr. 2012 Jul;96(1):5-13. doi: 10.3945/ajcn.111.025312. Epub 2012 May 30.