Skip to main content
OpenTrials
Completed

NCT Number: NCT02480504

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dietary intervention intermittent energy restriction

Other

Randomized clinical trial

continuous energy restriction

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2015
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.