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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480504
• Other study ID #: 2014/1702 (REK)
• Secondary ID: 1702
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: July 12, 2017
• Start date: September 2015
• Est. completion date: April 25, 2017

Study information

• Verified date: September 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 25, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• CVD
• Dietary Modification
• Obesity
• Weight Loss

Intervention

Other:
• dietary intervention intermittent energy restriction
Randomized clinical trial
• continuous energy restriction

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight reduction	Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects	1 year
Secondary	cholesterol	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol	1 year
Secondary	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
Secondary	blood pressure	Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure	1 year
Secondary	fasting glucose	Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose	1 year
Secondary	triglycerides	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides	1 year
Secondary	HbA1c	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c	1 year
Secondary	C-reactive protein (CRP)	Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP	1 year