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.

Study Overview

• Status: Completed
• Conditions: Obesity; Dietary Modification; CVD
• Intervention / Treatment: Other: dietary intervention intermittent energy restriction; Other: continuous energy restriction

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: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight reduction	Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cholesterol	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol	1 year
adverse events	Compare the effect of intermittent energy restriction and an isocaloric continuous energy restriction on cardiometabolic risk factors and tolerability and safety in obese subjects	1 year
blood pressure	Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure	1 year
fasting glucose	Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose	1 year
triglycerides	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides	1 year
HbA1c	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c	1 year
C-reactive protein (CRP)	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP	1 year

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Publications and helpful links

General Publications

• Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
• Sundfor 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): April 25, 2017
• Study Completion (Actual): April 25, 2017

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: 2014/1702 (REK); 1702 (REK (The national commitees for research ethics in Norway))