Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-09 @ 6:28 PM
Study NCT ID:
NCT02193659
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2014-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D002523', 'term': 'Edible Grain'}], 'ancestors': [{'id': 'D018556', 'term': 'Crops, Agricultural'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012639', 'term': 'Seeds'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2014-02-23', 'studyFirstSubmitQcDate': '2014-07-16', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'Circulating parameters of cholesterol total'}], 'secondaryOutcomes': [{'measure': 'Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'In this table the investigators present the weight of the three intervented groups'}, {'measure': 'Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'Circulating parameters of cholesterol HDL'}, {'measure': 'Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'Circulating parameters of cholesterol LDL'}, {'measure': 'Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'Circulating parameters of triglycerides'}, {'measure': 'Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'Circulating parameters of glucose'}, {'measure': 'BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'In this table the investigators present the BMI of the three intervented groups'}, {'measure': 'Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'In this table the investigators present the hip / waist measure of the three intervented groups'}, {'measure': 'Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'In this table the investigators present the systolic pressure of the three intervented groups'}, {'measure': 'Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.', 'timeFrame': '30 days', 'description': 'In this table the investigators present the diastolic pressure of the three intervented groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breakfast cereal', 'omega-3', 'cholesterol', 'lipidic profile', 'consumption', 'acceptability'], 'conditions': ['Overweight']}, 'descriptionModule': {'briefSummary': 'The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance. The main objective is to assess the effect of breakfast cereals intake with omega-3 on women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the small dyslipidemia.', 'detailedDescription': "The investigators performed an intervention including 133 women (age 25-70 years). Participants were randomly and single-blind distributed into three groups: Group 1 (n=38) consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and glucose were determined at the beginning and end of a 30-day test.\n\nStatistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data are reported as mean ± standard error of the mean (sem). Intra-group 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. Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and Tukey's honestly significant difference (HSD) were used in order to determine which means were significantly different from the others. In addition, Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* voluntarily participation\n* ages between 25-70 years\n* undergoing dyslipidemia\n* with no pharmacological treatment\n* cholesterol (250-300 mg/dL)\n* triglycerides (160-175 mg/dL)\n\nExclusion Criteria:\n\n* subjects undergoing any pharmacological treatment that may influence lipid metabolism\n* lipid levels outside the range of those specified in the inclusion criteria\n* subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.'}, 'identificationModule': {'nctId': 'NCT02193659', 'acronym': 'cereals', 'briefTitle': 'Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Miguel Hernandez de Elche'}, 'officialTitle': 'Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial', 'orgStudyIdInfo': {'id': 'Elena García-García 3'}, 'secondaryIdInfos': [{'id': 'Enrique Roche Collado', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III-FEDER PS09/01093'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cereals', 'description': 'For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet. The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day).', 'interventionNames': ['Dietary Supplement: Cereals']}], 'interventions': [{'name': 'Cereals', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Papilla multicereales con Omega-3 0628413', 'Papilla multicereales 0528413'], 'description': 'The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37). For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.', 'armGroupLabels': ['Cereals']}]}, '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-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'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, PID', 'investigatorFullName': 'Elena García García', 'investigatorAffiliation': 'Universidad Miguel Hernandez de Elche'}}}}