Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-20 @ 11:29 PM
Study NCT ID:
NCT02480504
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2015-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight reduction', 'timeFrame': '1 year', 'description': 'Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects'}], 'secondaryOutcomes': [{'measure': 'cholesterol', 'timeFrame': '1 year', 'description': 'Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on cholesterol'}, {'measure': 'adverse events', 'timeFrame': '1 year', 'description': 'Compare the effect of intermittent energy restriction and an isocaloric continuous energy restriction on cardiometabolic risk factors and tolerability and safety in obese subjects'}, {'measure': 'blood pressure', 'timeFrame': '1 year', 'description': 'Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on blood pressure'}, {'measure': 'fasting glucose', 'timeFrame': '1 year', 'description': 'Compare the effect of intermittent energy restriction and isocaloric continuous energy restriction on fasting glucose'}, {'measure': 'triglycerides', 'timeFrame': '1 year', 'description': 'Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on fasting triglycerides'}, {'measure': 'HbA1c', 'timeFrame': '1 year', 'description': 'Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on HbA1c'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': '1 year', 'description': 'Compare the effect of intermittent energy restriction and isocaloric contiuous energy restriction on CRP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'CVD', 'Dietary Modification']}, 'referencesModule': {'references': [{'pmid': '33512717', 'type': 'DERIVED', '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.'}, {'pmid': '29778565', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMethods: 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.\n\nDietary 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.\n\nPrimary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women between 21 to 70 years.\n* BMI (BMI 30-45 kg/m2).\n* stable weight within ±3 kg last 3 months.\n* 1 additional metabolic syndrome risk component.\n\nExclusion Criteria:\n\n* Diabetes if treated with insulin or incretin analogues.\n* History of bariatric surgery.\n* Use of antiobesity drugs or supplements.\n* Eating disorder.\n* Psychiatric illness that contributes to difficulties with study procedures.\n* Alcohol or drug abuse.'}, 'identificationModule': {'nctId': 'NCT02480504', 'briefTitle': 'Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity', 'orgStudyIdInfo': {'id': '2014/1702 (REK)'}, 'secondaryIdInfos': [{'id': '1702', 'type': 'OTHER', 'domain': 'REK (The national commitees for research ethics in Norway)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intermittent energy restriction', '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%.', 'interventionNames': ['Other: dietary intervention intermittent energy restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'continuous energy restriction', 'description': 'dietary intervention, continuous energy restrictions.Participants in the active comparator group will be asked to reduce daily energy intake by 22-23%', 'interventionNames': ['Other: continuous energy restriction']}], 'interventions': [{'name': 'dietary intervention intermittent energy restriction', 'type': 'OTHER', 'description': 'Randomized clinical trial', 'armGroupLabels': ['intermittent energy restriction']}, {'name': 'continuous energy restriction', 'type': 'OTHER', 'armGroupLabels': ['continuous energy restriction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus, Ullevål, avdeling for preventiv kardiologi', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MS in Nutrition, ph-D-student', 'investigatorFullName': 'Tine Mejlbo Sundfør', 'investigatorAffiliation': 'Oslo University Hospital'}}}}