Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01799720
Status:
COMPLETED
Last Update Posted:
2015-08-03
First Post:
2013-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oxidized Omega-3 Supplements With Different Oxidation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'egarcia@umh.es', 'phone': '965222025', 'title': 'Dr. Elena García García', 'phoneExt': '2025', 'organization': 'Universidad Miguel Hernández'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': '5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.', 'eventGroups': [{'id': 'EG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.', 'otherNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.', 'otherNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Violation of protocol norms', 'notes': 'The participant did not follow the rules and the diet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'protocol violation'}, {'term': 'Study abandonment', 'notes': 'The participants lost interest in the diet and deciced to abandon the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'abandonment'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '70.17', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '68.77', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '75.15', 'spread': '3.95', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '69.38', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '67.78', 'spread': '3.41', 'groupId': 'OG001'}, {'value': '74.29', 'spread': '3.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '0.01', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '0.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the height of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'metres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '27.43', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '28.65', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '29.00', 'spread': '1.50', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '27.10', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '26.94', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '28.64', 'spread': '1.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'kilogram / square metre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '86.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '87.2', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '86.0', 'spread': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '86.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '87.2', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '86.0', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'ratio*100', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '129.9', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '123.7', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '118.6', 'spread': '0.37', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '118.2', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '120.2', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '119.4', 'spread': '0.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'millimetres of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '77.2', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '73.3', 'spread': '0.34', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '68.9', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '72.8', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'millimetres of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '103.35', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '108.96', 'spread': '11.11', 'groupId': 'OG001'}, {'value': '99.72', 'spread': '4.53', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '116.24', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '111.37', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '108.26', 'spread': '2.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'milligram / decilitre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '246.64', 'spread': '12.92', 'groupId': 'OG000'}, {'value': '232.94', 'spread': '12.55', 'groupId': 'OG001'}, {'value': '236.78', 'spread': '4.17', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '217.76', 'spread': '8.98', 'groupId': 'OG000'}, {'value': '237.52', 'spread': '7.54', 'groupId': 'OG001'}, {'value': '227.22', 'spread': '6.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'milligram / decilitre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '164.41', 'spread': '15.43', 'groupId': 'OG000'}, {'value': '160.41', 'spread': '11.34', 'groupId': 'OG001'}, {'value': '174.83', 'spread': '19.83', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '125.52', 'spread': '12.34', 'groupId': 'OG000'}, {'value': '116.88', 'spread': '11.43', 'groupId': 'OG001'}, {'value': '130.04', 'spread': '10.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'milligram / decilitre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'OG002', 'title': 'Diet', 'description': 'Participants from group 3 only took diet. Follow-up 30 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '22.70', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '24.90', 'spread': '2.96', 'groupId': 'OG001'}, {'value': '23.54', 'spread': '3.92', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '20.69', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '18.46', 'spread': '1.62', 'groupId': 'OG001'}, {'value': '19.94', 'spread': '2.19', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.', 'unitOfMeasure': 'Units / litre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules a day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days'}, {'id': 'FG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules a day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days'}, {'id': 'FG002', 'title': 'Diet', 'description': 'Participants from group 3 took only diet, Follow-up 30 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Began the Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Began the Treatment and Finished it', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The place where women were recruited for our study was a pharmacy located in the city centre of Elche, during October 2010. Elche is an industrial city located in the Southeast of Spain, with a population of 230 000 inhabitants.', 'preAssignmentDetails': 'Before the survey began, 14 people were discarded from the survey because their cholesterol levels were lower than the inclusion standards.\n\n5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Less Oxidized Oil and Diet', 'description': 'Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'BG001', 'title': 'More Oxidized Oil and Diet', 'description': 'Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.'}, {'id': 'BG002', 'title': 'Only Diet', 'description': 'Participants from group 3 only received the diet. Follow-up 30 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.65', 'spread': '12.65', 'groupId': 'BG000'}, {'value': '56.82', 'spread': '12.18', 'groupId': 'BG001'}, {'value': '51.94', 'spread': '10.80', 'groupId': 'BG002'}, {'value': '55.14', 'spread': '11.87', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-12', 'studyFirstSubmitDate': '2013-02-19', 'resultsFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-08', 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.'}], 'secondaryOutcomes': [{'measure': 'Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the height of the three intervented groups. Data are mean ± sem.'}, {'measure': 'Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.'}, {'measure': 'Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.'}, {'measure': 'Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.'}, {'measure': 'Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.'}, {'measure': 'Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.'}, {'measure': 'Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.'}, {'measure': 'Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.'}, {'measure': 'Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).', 'timeFrame': 'Days 1 and 30', 'description': 'In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['blood cholesterol', 'blood lipid profile', 'triglycerides', 'commercial pills', 'fish oil', 'lipid peroxidation', 'Circulating lipidic profile'], 'conditions': ['Overweight']}, 'referencesModule': {'references': [{'pmid': '23863036', 'type': 'DERIVED', 'citation': 'Garcia-Hernandez VM, Gallar M, Sanchez-Soriano J, Micol V, Roche E, Garcia-Garcia E. Effect of omega-3 dietary supplements with different oxidation levels in the lipidic profile of women: a randomized controlled trial. Int J Food Sci Nutr. 2013 Dec;64(8):993-1000. doi: 10.3109/09637486.2013.812619. Epub 2013 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The oxidation level of unsaturated fatty acid supplements commercialized in capsules could be a serious problem for manufacturers and a risk to consumers; health by ingesting substances whose effects are not desired. Therefore, the main objective of this paper is to analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose the investigators have designed a single-blind, parallel-groups, randomized controlled trial. Finally, 52 women between 25 and 75 years old were randomly distributed into three groups: (1) took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, (2) took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet and (3) no capsules, only received the diet. There was a 30 days follow-up . All groups followed a low cholesterol diet. Circulating glucose, total cholesterol, triglycerides and glutamic pyruvic transaminase were determined at the beginning and end of a 30 day period.', 'detailedDescription': 'The assignment of women to distinct groups was carried out following the classification criteria established by (NCEP, 2002), and performed by the research team. Women were randomly assigned to one of three parallel groups, in a near 1:1:1 ratio. Group 1 (n=20) took two capsules per day of less oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Group 2 (n=18) consumed two capsules per day of oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Finally, group 3 (n=19) performed the diet but did not take any capsule. Therefore, the design was a single-blind (participants did not know what type of capsule they were receiving), parallel-group, randomized controlled trial conducted at the Miguel Hernández University of Elche (Spain).\n\nStatistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA); likewise, significance was defined at p\\<0.05. Data are reported as mean standard error of the mean (SEM). Intragroup statistical comparisons were performed using the following hypothesis tests, both parametric and non-parametric: t-test, sign test and signed rank test for paired samples. Intergroup statistical comparisons were performed using the one-way analysis of variance (ANOVA) and the Kruskal-Wallis hypothesis tests. Also, Fisher least significant difference (LSD)Multiple Range Test and Tukey HSD were used in order to determine which means were significantly different from the others.\n\nMethods for additional analyses Generalized multiple regression was used to statistically analyse the relationships between the variations in the lipid profile and the consumption of w-3 dietary supplements.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of dyslipemia with no indication of drug treatment\n* blood cholesterol levels ranging 250-300 mg/dL\n* triglycerides (TG) 160-175 mg/dL\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* participation in another supplementary feeding programme'}, 'identificationModule': {'nctId': 'NCT01799720', 'acronym': 'GPTPASPAD', 'briefTitle': 'Oxidized Omega-3 Supplements With Different Oxidation', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Miguel Hernandez de Elche'}, 'officialTitle': 'Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Elena García-García'}, 'secondaryIdInfos': [{'id': 'Enrique Roche Collado', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III-FEDER PS09/01093'}, {'id': 'Vicente Micol Molina', 'type': 'OTHER_GRANT', 'domain': 'PROMETEO/2012/007 from Generalitat Valenciana'}, {'id': 'Enrique Roche Collado', 'type': 'OTHER_GRANT', 'domain': 'CIBERobn (CB12/03/30038)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Less oxidized oil and diet', 'description': 'Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days', 'interventionNames': ['Dietary Supplement: Less oxidized oil and diet']}, {'type': 'EXPERIMENTAL', 'label': 'More oxidized oil and diet', 'description': 'Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet . Follow-up 30 days', 'interventionNames': ['Dietary Supplement: More oxidized oil and diet']}, {'type': 'EXPERIMENTAL', 'label': 'Hypercholesterolemic diet', 'description': 'Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 3 only took diet and no capsules. Follow-up 30 days', 'interventionNames': ['Drug: Hypercholesterolemic diet']}], 'interventions': [{'name': 'Less oxidized oil and diet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['less oxidized oil'], 'description': 'Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, . Follow-up 30 days', 'armGroupLabels': ['Less oxidized oil and diet']}, {'name': 'More oxidized oil and diet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['More oxidized oil'], 'description': 'Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet . Follow-up 30 days', 'armGroupLabels': ['More oxidized oil and diet']}, {'name': 'Hypercholesterolemic diet', 'type': 'DRUG', 'description': 'Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 3 only received the diet and no capsules. Follow-up 30 days', 'armGroupLabels': ['Hypercholesterolemic diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03202', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Pharmacy Iborra Campos', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}], 'overallOfficials': [{'name': 'Elena García, PDI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Miguel Hernandez de Elche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Miguel Hernandez de Elche', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'University of Alicante', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD,PID', 'investigatorFullName': 'Elena García García', 'investigatorAffiliation': 'Universidad Miguel Hernandez de Elche'}}}}