Clinical trial NCT02480504: Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Official title: Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
CVD
Dietary Modification
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 112
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: weight reduction
timeFrame: 1 year
Secondary outcomes:
measure: cholesterol
timeFrame: 1 year
measure: adverse events
timeFrame: 1 year
measure: blood pressure
timeFrame: 1 year
measure: fasting glucose
timeFrame: 1 year
measure: triglycerides
timeFrame: 1 year
measure: HbA1c
timeFrame: 1 year
measure: C-reactive protein (CRP)
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi
Study officials:
References:
citation: 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.
citation: 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.