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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-04-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity CVD Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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%.

Group Type EXPERIMENTAL

dietary intervention intermittent energy restriction

Intervention Type OTHER

Randomized clinical trial

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%

Group Type ACTIVE_COMPARATOR

continuous energy restriction

Intervention Type OTHER

Interventions

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dietary intervention intermittent energy restriction

Randomized clinical trial

Intervention Type OTHER

continuous energy restriction

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes