Obesity, Type 2 Diabetes, Cardiovascular Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAlginate beverage
The dosage is 3x500ml daily
DIETARY_SUPPLEMENTControl beverage
The dosage is 3x500ml daily
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | 12 Weeks |
Secondary
| Measure | 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 |
Countries
Denmark
Outcome results
None listed