Obesity
Conditions
Brief summary
The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and cardiovascular diseases.
Interventions
BEHAVIORALDietary intervention
Instruction to diet for 6 month
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* abdominal obesity
Exclusion criteria
* BMI \> 45, previous weight change
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight (kg) | 26 weeks | Change in body weight from randomization to end of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body fat percentage | 26 weeks | Change in body fat percentage (DEXA-scanning) |
| Dietary compliance | 26 weeks | Level of dietary compliance |
| Changes in components of the metabolic syndrome | 26 weeks | Changes in the number of components of the metabolic syndrome |
| Achievement of 5% weight loss | 26 weeks | Achievement of 5% weight loss from randomization to end of intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbial composition and association with Body weight change | 26 weeks | Diet specific change in body weight according to relative abundance of microbial bacteria, e.g., baseline Prevotella/Bacteroides ratio \[proxy for enterotypes\]) |
| Molecular regulation of glucose homeostasis | 26 weeks | Diet specific molecular regulation in adipose and muscle tissue |
| Human salivary amylase gene copy number (AMY1 CN) and association with Body weight change [ Time Frame: 26 weeks ] | 26 weeks | Diet specific change in body weight according to AMY1 CN |
| Change in gastrointestinal microbial composition | 26 weeks | Diet specific changes in relative abundance of microbial bacteria |
Countries
Denmark
Outcome results
None listed