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

Not Applicable

Completed

• Conditions: Obesity; Dietary Modification; CVD
• Interventions: Other: dietary intervention intermittent energy restriction; Other: continuous energy restriction

• Registration Number: NCT02480504
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-24
• Study Start: 2015-09
• Status Verified: 2016-09
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent energy restriction	dietary intervention 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%.
continuous energy restriction	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%

Primary Outcome Measures

Name	Time	Method
weight reduction	1 year	Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects

Secondary Outcome Measures

Name	Time	Method
HbA1c	1 year	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c
adverse events	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
fasting glucose	1 year	Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose
triglycerides	1 year	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides
C-reactive protein (CRP)	1 year	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP
blood pressure	1 year	Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure
cholesterol	1 year	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol

Trial Locations

Locations (1)

Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi; 🇳🇴 Oslo, Norway