Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-04 @ 12:44 AM
Study NCT ID:
NCT03082794
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2017-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2017-03-04', 'studyFirstSubmitQcDate': '2017-03-12', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline', 'description': 'assessed in kg'}, {'measure': 'Total cholesterol (Total-C)', 'timeFrame': 'Baseline', 'description': 'assessed in mg/dl'}, {'measure': 'High-density lipoprotein -cholesterol (HDL-C)', 'timeFrame': 'Baseline', 'description': 'assessed in mg/dl'}, {'measure': 'Low-density lipoprotein -cholesterol (LDL-C)', 'timeFrame': 'Baseline', 'description': 'assessed in mg/dl'}, {'measure': 'Triglycerides (TG)', 'timeFrame': 'Baseline', 'description': 'assessed in mg/dl'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '3-month', 'description': 'assessed in kg'}, {'measure': 'Total cholesterol (Total-C)', 'timeFrame': '3-month', 'description': 'assessed in mg/dl'}, {'measure': 'High-density lipoprotein -cholesterol (HDL-C)', 'timeFrame': '3-month', 'description': 'assessed in mg/dl'}, {'measure': 'Low-density lipoprotein -cholesterol (LDL-C)', 'timeFrame': '3-month', 'description': 'assessed in mg/dl'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary Formulations', 'Lifestyle', 'Obesity', 'Overweight', 'weight loss'], 'conditions': ['Men', 'Life Style', 'Lipid Metabolism Disorders', 'Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method. The present study aimed to determine the effects of negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with low-calorie diet in men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Participants were non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smokers\n* Weight-stable (± 2 kg, for more than one year)\n* No history of regular exercise (in at least three months before the study).\n\nExclusion Criteria:\n\n* History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph\n* History of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.'}, 'identificationModule': {'nctId': 'NCT03082794', 'briefTitle': 'Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men', 'organization': {'class': 'OTHER', 'fullName': 'P.L.Shupik National Medical Academy of Post-Graduate Education'}, 'officialTitle': 'Investigating the Effects of Negative Calorie Diet Compared With Low-Calorie Diet on Weigh Loss and Lipid Profile in Sedentary Overweight/Obese Middle-Aged and Older Men', 'orgStudyIdInfo': {'id': 'no Grant 4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group I', 'description': 'Study group I (53 participants) received the NCD (details of diet: 15% protein, 75% carbohydrates, 10% fat). Both groups had 15% caloric restriction from their maintenance energy requirements.', 'interventionNames': ['Dietary Supplement: NCD']}, {'type': 'EXPERIMENTAL', 'label': 'Study group II', 'description': 'Study group II (51 participants) received the LCD or healthy weight maintenance diet (details of diet: 15% protein, 55% carbohydrates, 30% fat).Both groups had 15% caloric restriction from their maintenance energy requirements.', 'interventionNames': ['Dietary Supplement: LCD']}], 'interventions': [{'name': 'NCD', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['group I'], 'description': 'Negative Calorie Diet', 'armGroupLabels': ['Study group I']}, {'name': 'LCD', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['group II'], 'description': 'Low Calorie Diet', 'armGroupLabels': ['Study group II']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'P.L.Shupik National Medical Academy of Post-Graduate Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof. of sports medicine (sports injury and corrective movement)', 'investigatorFullName': 'Mohammadreza Rezaeipour, MD, PhD', 'investigatorAffiliation': 'University of Sistan and Baluchestan'}}}}