Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-03-28 @ 11:51 AM
Study NCT ID:
NCT01659450
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2012-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2012-08-01', 'studyFirstSubmitQcDate': '2012-08-04', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'better weight control', 'timeFrame': '7 months'}], 'primaryOutcomes': [{'measure': 'better weight maintenance by LED', 'timeFrame': '7 months'}], 'secondaryOutcomes': [{'measure': 'better CVD risks status by LED', 'timeFrame': '7 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overweight', 'obesity', 'low energy dense'], 'conditions': ['Body Weight Decreased']}, '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.'}]}, 'descriptionModule': {'briefSummary': 'Investigators presumed that low energy density (LED) diet consumers will have lower risk of cardiovascular disease and are able to maintain their weight longer .', 'detailedDescription': 'Previous studies introduced different dietary interventions for weight loss maintenance. Besides the debate on low fat or low carbohydrate diets, focusing on some food groups including fruits, vegetables and low fat dairies in the diet may be helpful for weight maintenance. However, energy intake is the key factor of weight maintenance. Energy intake will decrease by reducing energy density (ED) of a diet without producing short-term calorie restriction or feeling hunger. There are several studies which showed the beneficial effects of low energy density diets on weight reduction. However, few studies discuses regarding the effects of such diets on weight maintenance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* who were on weight loss diet for the last one year and additionally, they did not want to lose more weight.\n* Non-pregnant, non-lactaries and non-smokers aged 40-70 years included in the present study\n\nExclusion Criteria:\n\n* dietary poor compliance'}, 'identificationModule': {'nctId': 'NCT01659450', 'briefTitle': 'Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Low Energy Density Diet and Weight Loss Maintenance', 'orgStudyIdInfo': {'id': 'Low energy density diet'}, 'secondaryIdInfos': [{'id': 'IUMS', 'type': 'OTHER', 'domain': 'Isfahan University of Medical Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low energy dense', 'description': 'Diet of the LED group contained 30%fat, 15% protein and 55% carbohydrate. Most of the consumed carbohydrates in the LED diet group were fruits, vegetables and whole grains. In addition, this group received more servings of vegetables groups daily in the form of liquid diets or some menus contain more vegetables', 'interventionNames': ['Other: low energy dense', 'Other: diet']}, {'type': 'EXPERIMENTAL', 'label': 'control', 'description': 'In the group with a control diet, 35% of the energy was provided by fat, 15% by protein and 50% by carbohydrate', 'interventionNames': ['Other: control', 'Other: diet']}], 'interventions': [{'name': 'low energy dense', 'type': 'OTHER', 'otherNames': ['LED'], 'description': 'This group received a diet appropriate with their weight in the form of low energy density diet', 'armGroupLabels': ['Low energy dense']}, {'name': 'control', 'type': 'OTHER', 'otherNames': ['usual'], 'description': 'This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.', 'armGroupLabels': ['control']}, {'name': 'diet', 'type': 'OTHER', 'otherNames': ['low energy dense', 'control'], 'description': 'Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.', 'armGroupLabels': ['Low energy dense', 'control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Leila Azadbakht, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leila Azadbakht', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}