Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02480504
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Tine Mejlbo Sundfør, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE June 3, 2015
First Posted Date  ICMJE June 24, 2015
Last Update Posted Date July 17, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date April 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
weight reduction [ Time Frame: 1 year ]
Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2015)
  • cholesterol [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol
  • adverse events [ 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
  • blood pressure [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure
  • fasting glucose [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose
  • triglycerides [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides
  • HbA1c [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c
  • C-reactive protein (CRP) [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • cholesterol [ Time Frame: 1 year ]
    Compare the effect of intermittend energy restriction and isocaloric contiuous energy restriction on cholesterol
  • adverse events [ 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
  • blood pressure [ Time Frame: 1 year ]
    Compare the effect of intermittend energy restriction and isocaloric contiuous energy restriction on blood pressure
  • fasting glucose [ Time Frame: 1 year ]
    Compare the effect of intermittend energy restriction and isocaloric contiuous energy restriction on fasting glucose
  • triglycerides [ Time Frame: 1 year ]
    Compare the effect of intermittend energy restriction and isocaloric contiuous energy restriction on fasting triglycerides
  • HbA1c [ Time Frame: 1 year ]
    Compare the effect of intermittend energy restriction and isocaloric contiuous energy restriction on HbA1c
  • CRP [ Time Frame: 1 year ]
    Compare the effect of intermittend energy restriction and isocaloric contiuous energy restriction on CRP
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Official Title  ICMJE Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • CVD
  • Dietary Modification
Intervention  ICMJE
  • Other: dietary intervention intermittent energy restriction
    Randomized clinical trial
  • Other: continuous energy restriction
Study Arms  ICMJE
  • Experimental: intermittent energy restriction
    dietary intervention, intermittent energy restriction. Participants in the experimental group will follow av 5:2 diet and consume a very low calorie diet providing 400 (females) to 600 (males) calories of energy to days a week and for an average male participant, this will reduce energy intake approximately 22%.
    Intervention: Other: dietary intervention intermittent energy restriction
  • Active Comparator: continuous energy restriction
    dietary intervention, continuous energy restrictions.Participants in the active comparator group will be asked to reduce daily energy intake by 22-23%
    Intervention: Other: continuous energy restriction
Publications * Sundfør TM, Svendsen M, Tonstad S. Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: A randomized 1-year trial. Nutr Metab Cardiovasc Dis. 2018 Jul;28(7):698-706. doi: 10.1016/j.numecd.2018.03.009. Epub 2018 Mar 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2017)
112
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2015)
120
Actual Study Completion Date  ICMJE April 25, 2017
Actual Primary Completion Date April 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02480504
Other Study ID Numbers  ICMJE 2014/1702 (REK)
1702 ( Other Identifier: REK (The national commitees for research ethics in Norway) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tine Mejlbo Sundfør, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oslo University Hospital
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP