Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 7:16 AM
Study NCT ID:
NCT03369535
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2017-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabonomics to Investigate Effects of Healthy Diets on Blood Pressure: the OmniHeart Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2017-12-06', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure (SBP)', 'timeFrame': 'post 6 weeks intervention', 'description': 'SBP reduction in mmHg'}], 'secondaryOutcomes': [{'measure': 'Diastolic blood pressure (DBP)', 'timeFrame': 'post 6 weeks intervention', 'description': 'DBP reduction in mmHg'}, {'measure': 'low density lipoprotein cholesterol (LDL)', 'timeFrame': 'post 6 weeks intervention', 'description': 'LDL reduction in mg/dl'}, {'measure': 'high density lipoprotein cholesterol (HDL)', 'timeFrame': 'post 6 weeks intervention', 'description': 'HDL reduction in mg/dl'}, {'measure': 'triglycerides (TG)', 'timeFrame': 'post 6 weeks intervention', 'description': 'TG reduction in mg/dl'}, {'measure': 'total cholesterol', 'timeFrame': 'post 6 weeks intervention', 'description': 'reduction in mg/dl'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '29506183', 'type': 'DERIVED', 'citation': 'Loo RL, Zou X, Appel LJ, Nicholson JK, Holmes E. Characterization of metabolic responses to healthy diets and association with blood pressure: application to the Optimal Macronutrient Intake Trial for Heart Health (OmniHeart), a randomized controlled study. Am J Clin Nutr. 2018 Mar 1;107(3):323-334. doi: 10.1093/ajcn/nqx072.'}]}, 'descriptionModule': {'briefSummary': 'To compare the urinary metabolomes on individuals undergone three different healthy diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.', 'detailedDescription': 'BACKGROUND:\n\nThis study based on the OmniHeart dietary intervention study, a randomized, three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of three DASH-like diets: a carbohydrate-rich (CARB) diet pattern, a rich in protein (PROT) and a rich in unsaturated (MUFA) fat, predominantly monounsaturated fat diet (see full details of OmniHeart dietary intervention https://clinicaltrials.gov/ct2/show/record/NCT00051350).\n\nThis metabonomic study aims to evaluate the feasibility of identifying individuals showing variation in clinical response to three different healthy diets, with the purpose of reducing cardiovascular disease (CVD) risk, using proton nuclear magnetic resonance (NMR) based metabolic phenotyping approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with pre-hypertension (systolic BP of 120 to 139 mmHg and/or diastolic BP of 80 to 89 mmHg) or stage 1 hypertension (systolic BP of 140 to 159 mm Hg and/or diastolic BP of 90 to 99 mm Hg) and without diabetes or prior CVD\n\nExclusion Criteria:\n\n* CVD or diabetes'}, 'identificationModule': {'nctId': 'NCT03369535', 'briefTitle': 'Metabonomics to Investigate Effects of Healthy Diets on Blood Pressure: the OmniHeart Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Kent'}, 'officialTitle': 'Urinary Metabolic Phenotyping of Diet-cardiovascular Disease Risk Associations: the OmniHeart Feeding Trial', 'orgStudyIdInfo': {'id': '11/LO/0773'}, 'secondaryIdInfos': [{'id': 'G1002151', 'type': 'OTHER_GRANT', 'domain': 'MRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Baseline', 'description': 'Baseline corresponds to typical American diet', 'interventionNames': ['Other: CARB rich diet', 'Other: MUFA rich diet', 'Other: PROT rich diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PROT rich diet', 'description': 'Protein rich diet for 6 weeks', 'interventionNames': ['Other: CARB rich diet', 'Other: MUFA rich diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MUFA rich diet', 'description': 'MUFA rich diet for 6 weeks', 'interventionNames': ['Other: CARB rich diet', 'Other: PROT rich diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CARB rich diet', 'description': 'CARB rich diet for 6 weeks', 'interventionNames': ['Other: MUFA rich diet', 'Other: PROT rich diet']}], 'interventions': [{'name': 'CARB rich diet', 'type': 'OTHER', 'description': 'Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention', 'armGroupLabels': ['Baseline', 'MUFA rich diet', 'PROT rich diet']}, {'name': 'MUFA rich diet', 'type': 'OTHER', 'description': 'Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention', 'armGroupLabels': ['Baseline', 'CARB rich diet', 'PROT rich diet']}, {'name': 'PROT rich diet', 'type': 'OTHER', 'description': 'Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention', 'armGroupLabels': ['Baseline', 'CARB rich diet', 'MUFA rich diet']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}