Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
2 other identifiers
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2017
CompletedJuly 17, 2017
September 1, 2016
1.6 years
June 3, 2015
July 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
weight reduction
Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects
1 year
Secondary Outcomes (7)
cholesterol
1 year
adverse events
1 year
blood pressure
1 year
fasting glucose
1 year
triglycerides
1 year
- +2 more secondary outcomes
Study Arms (2)
intermittent energy restriction
EXPERIMENTALdietary 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%.
continuous energy restriction
ACTIVE COMPARATORdietary intervention, continuous energy restrictions.Participants in the active comparator group will be asked to reduce daily energy intake by 22-23%
Interventions
Randomized clinical trial
Eligibility Criteria
You may qualify if:
- Men and women between 21 to 70 years.
- BMI (BMI 30-45 kg/m2).
- stable weight within ±3 kg last 3 months.
- additional metabolic syndrome risk component.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi
Oslo, 0424, Norway
Related Publications (2)
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.
PMID: 33512717DERIVEDSundfor 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.
PMID: 29778565DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MS in Nutrition, ph-D-student
Study Record Dates
First Submitted
June 3, 2015
First Posted
June 24, 2015
Study Start
September 1, 2015
Primary Completion
April 25, 2017
Study Completion
April 25, 2017
Last Updated
July 17, 2017
Record last verified: 2016-09