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

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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

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.

Condition or disease Intervention/treatment Phase
Obesity CVD Dietary Modification Other: dietary intervention intermittent energy restriction Other: continuous energy restriction Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Study Start Date : September 2015
Actual Primary Completion Date : April 25, 2017
Actual Study Completion Date : April 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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%.
Other: dietary intervention intermittent energy restriction
Randomized clinical trial

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%
Other: continuous energy restriction



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. cholesterol [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol

  2. 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

  3. blood pressure [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure

  4. fasting glucose [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose

  5. triglycerides [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides

  6. HbA1c [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c

  7. C-reactive protein (CRP) [ Time Frame: 1 year ]
    Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480504


Locations
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Norway
Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tine Mejlbo Sundfør, MS in Nutrition, ph-D-student, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02480504     History of Changes
Other Study ID Numbers: 2014/1702 (REK)
1702 ( Other Identifier: REK (The national commitees for research ethics in Norway) )
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
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Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes