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

University of Copenhagen

Status

Completed

Conditions

Obesity

Type 2 Diabetes

Cardiovascular Disease

Treatments

Dietary Supplement: Control beverage

Dietary Supplement: Alginate beverage

Study type

Interventional

Funder types

Other

Identifiers

NCT01231178

Scientific Ethical Committee (Registry Identifier)

B272

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)