ObesityNCT02480504
Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
A study testing dietary intervention intermittent energy restriction and continuous energy restriction in people with Obesity and CVD, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, CVD, Dietary Modification
- What is being tested?
- dietary intervention intermittent energy restriction and continuous energy restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to 25 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Norway1 site
Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi
Oslo, 0424
About this study
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.
Read the 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.
- Conditions
- Obesity, CVD, Dietary Modification
- Being tested
- dietary intervention intermittent energy restriction, continuous energy restriction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary intervention intermittent energy restrictionOther
Randomized clinical trial
continuous energy restrictionOther
| Study group | Role | What they receive |
|---|---|---|
| intermittent energy restriction | Experimental | 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%. Receives: Other: dietary intervention intermittent energy restriction |
| continuous energy restriction | Active comparator | dietary intervention, continuous energy restrictions.Participants in the active comparator group will be asked to reduce daily energy intake by 22-23% Receives: Other: continuous energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight reduction
Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects
Measured: 1 year
Secondary outcomes (7)
cholesterol
Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol
Measured: 1 year
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
Measured: 1 year
blood pressure
Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure
Measured: 1 year
fasting glucose
Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose
Measured: 1 year
triglycerides
Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides
Measured: 1 year
HbA1c
Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c
Measured: 1 year
C-reactive protein (CRP)
Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startSep 2015
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tine Mejlbo Sundfør, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480504
- Sponsor's protocol ID
- 2014/1702 (REK)
- Other IDs
- 1702
- Status last verified
- Sep 2016
- First submitted
- 3 Jun 2015
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33512717Sundfor 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.
PubMed 29778565
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
- ClinicalTrials.gov ID
- NCT02480504
- Acronym / sponsor ID
- 2014/1702 (REK)
- Conditions
- Obesity, CVD, Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intermittent energy restriction | Experimental | Other: dietary intervention intermittent energy restrictiondietary 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 comparator | Other: continuous energy restrictiondietary intervention, continuous energy restrictions.Participants in the active comparator group will be asked to reduce daily energy intake by 22-23% |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary intervention intermittent energy restrictionRandomized clinical trial | Other | intermittent energy restriction |
| continuous energy restriction | Other | continuous energy restriction |
Primary outcome
weight reduction
Time frame: 1 year
Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects
7 secondary outcomes
cholesterol
Time frame: 1 year
adverse events
Time frame: 1 year
blood pressure
Time frame: 1 year
fasting glucose
Time frame: 1 year
triglycerides
Time frame: 1 year
HbA1c
Time frame: 1 year
C-reactive protein (CRP)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Derived from this study: PubMed 33512717Allaf 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.
- Derived from this study: PubMed 29778565Sundfor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention intermittent energy restriction and continuous energy restriction in people with Obesity and CVD, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight reduction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480504, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.