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

University of Oslo (UIO)

Status: Completed

Conditions: CVD; Dietary Modification; Obesity

Treatments: Other: continuous energy restriction; Other: dietary intervention intermittent energy restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT02480504

1702

2014/1702 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

112 participants in 2 patient groups

intermittent energy restriction

Experimental group

Description:

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%.

Treatment:

Other: dietary intervention intermittent energy restriction

continuous energy restriction

Active Comparator group

Description:

dietary intervention, continuous energy restrictions.Participants in the active comparator group will be asked to reduce daily energy intake by 22-23%

Treatment:

Other: continuous energy restriction