Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-30 @ 12:07 PM
Study NCT ID:
NCT02480504
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1702 | OTHER | REK (The national commitees for research ethics in Norway) | View |