Overview

This trial is active, not recruiting.

Conditions obesity, cvd, dietary modification
Treatments dietary intervention intermittent energy restriction, continuous energy restriction
Sponsor Oslo University Hospital
Start date September 2015
End date May 2017
Trial size 120 participants
Trial identifier NCT02480504, 1702, 2014/1702 (REK)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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%.
dietary intervention intermittent energy restriction
Randomized clinical trial
(Active Comparator)
dietary intervention, continuous energy restrictions.Participants in the active comparator group will be asked to reduce daily energy intake by 22-23%
continuous energy restriction

Primary Outcomes

Measure
weight reduction
time frame: 1 year

Secondary Outcomes

Measure
cholesterol
time frame: 1 year
adverse events
time frame: 1 year
blood pressure
time frame: 1 year
fasting glucose
time frame: 1 year
triglycerides
time frame: 1 year
HbA1c
time frame: 1 year
C-reactive protein (CRP)
time frame: 1 year

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

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.

Additional Information

Official title Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.