Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi
Oslo, 0424, Norway
NCT Number: NCT02480504
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.
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Notify Me21 year–70 year
All sexes
Interventional
Not applicable
Oslo, 0424, Norway
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Randomized clinical trial
Time frame: 1 year
Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects
Time frame: 1 year
Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol
Time frame: 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
Time frame: 1 year
Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure
Time frame: 1 year
Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose
Time frame: 1 year
Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides
Time frame: 1 year
Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c
Time frame: 1 year
Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP
Oslo University Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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