Obesity, CVD, Dietary Modification
Conditions
Brief summary
A randomized clinical trial comparing the effect on weight reduction and cardiometabolic risk factors of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects.
Detailed description
Background: The optimal diet for treating obesity and cardiovascular disease (CVD) risk is still not clarified. Could a five plus two diet, a form of intermittent energy restriction lead to good adherence, similar weight loss and reduction in CVD risk factors as a isocaloric continuous energy restrictions in obese subjects. Methods: The study is a randomized controlled clinical trial in 120 men and women between 21 to 70 years with BMI (BMI 30-45 kg/m2), stable weight within ±3 kg last 3 months and 1 additional metabolic syndrome risk component. Dietary intervention: Randomization will be to one of two diet groups. Participants in the intervention group will follow av 5:2 diet and participants in the control group will follow an isocaloric continuous energy restriction. Primary research question: Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects? Secondary research questions Compare the effect of intermittent energy restriction and an isocaloric continuous energy restriction on cardiometabolic risk factors and tolerability and safety in obese subjects. The project consist of to randomized controlled clinical trials.
Interventions
OTHERdietary intervention intermittent energy restriction
Randomized clinical trial
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women between 21 to 70 years. * BMI (BMI 30-45 kg/m2). * stable weight within ±3 kg last 3 months. * 1 additional metabolic syndrome risk component.
Exclusion criteria
* Diabetes if treated with insulin or incretin analogues. * History of bariatric surgery. * Use of antiobesity drugs or supplements. * Eating disorder. * Psychiatric illness that contributes to difficulties with study procedures. * Alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight reduction | 1 year | Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 1 year | Compare the effect of intermittent energy restriction and an isocaloric continuous energy restriction on cardiometabolic risk factors and tolerability and safety in obese subjects |
| blood pressure | 1 year | Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure |
| fasting glucose | 1 year | Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose |
| cholesterol | 1 year | Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol |
| HbA1c | 1 year | Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c |
| C-reactive protein (CRP) | 1 year | Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP |
| triglycerides | 1 year | Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides |
Countries
Norway
Outcome results
None listed