Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-04 @ 8:39 AM
Study NCT ID:
NCT02410668
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2015-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject
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': 'D008043', 'term': 'Linseed Oil'}], 'ancestors': [{'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2015-04-06', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight', 'timeFrame': '12 weeks'}, {'measure': 'waist and hip circumference', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'lipid profile', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '30843767', 'type': 'DERIVED', 'citation': 'Yari Z, Rahimlou M, Poustchi H, Hekmatdoost A. Flaxseed supplementation improves anthropometric measurements, metabolic, and inflammatory biomarkers in overweight and obese adults. Int J Vitam Nutr Res. 2022 Jul;92(3-4):161-168. doi: 10.1024/0300-9831/a000565. Epub 2019 Mar 7.'}]}, 'descriptionModule': {'briefSummary': "To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory factors in subjects with over weight and obesity, 50 patients will be randomly allocated to receive placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, weight, waist and hip circumference, lipid profile and some inflammatory markers will be assessed and compared between groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 to 70 years\n* Body Mass Index (BMI) between 25-40\n\nExclusion Criteria:\n\n* diabetes mellitus\n* cardiovascular diseases and cancers\n* major systemic diseases\n* gastrointestinal problems\n* liver and renal failure\n* history of allergy or high consumption of nuts, flaxseed, or sesame seeds\n* weight loss within the past 6 mo of \\>5% of body weight or current adherence to a weight-reduction diet\n* pregnancy, lactation'}, 'identificationModule': {'nctId': 'NCT02410668', 'briefTitle': 'The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'The Effects of Flaxseed Supplement on Weight, Lipid Profile and Inflammatory Factors in Overweight and Obese Subjects', 'orgStudyIdInfo': {'id': '1368'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Flaxseed', 'description': '30 grams Flaxseed powder combine with dietary and exercise recommendation', 'interventionNames': ['Dietary Supplement: flaxseed', 'Behavioral: Exercise recommendation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'dietary and exercise recommendation', 'interventionNames': ['Dietary Supplement: Placebo', 'Behavioral: Exercise recommendation']}], 'interventions': [{'name': 'flaxseed', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Flaxseed']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['control']}, {'name': 'Exercise recommendation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Flaxseed', 'control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}