Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-06 @ 11:37 AM
Study NCT ID:
NCT02169661
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2011-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Burger and Beetroot Study - Lipid Oxidation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-20', 'studyFirstSubmitDate': '2011-07-26', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid peroxides', 'timeFrame': 'up to 24 hours', 'description': 'Indices of oxidised lipids in plasma'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'up to 24 hours', 'description': 'Systolic and diastolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oxidative stress', 'Lipid peroxides', 'Phytochemicals', 'Ready meals', 'Beetroot', 'Blood pressure'], 'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Consumption of "ready meals" and other convenience foods are rapidly increasing. However, their nutritional value is problematical. For example, many are high in fats which are potentially oxidisable resulting in the formation of toxic end products. Consequently the aim of this study is to assess whether consumption of "ready meals" rich in certain fats leads to a post-prandial increase in lipid oxidation products in plasma and whether this can be ameliorated by reformulating the meals with natural extracts rich in phytochemicals with potential antioxidant activity in the stomach', 'detailedDescription': 'Many of these lipid oxidation products such as malondialdehyde are known to be genotoxic and potentially detrimental to health. Consequently the aim of this study is to assess whether consumption of "ready meals" rich in certain fats leads to a post-prandial increase in lipid oxidation products in plasma and whether this can be ameliorated by reformulating the meals with natural extracts rich in phytochemicals with potential antioxidant activity in the stomach.\n\nDiet design requirements:\n\nThe basic "ready meal" is a turkey burger consisting of\n\n* 50% fat\n* 20% protein\n* 30% carbohydrate.\n\nHowever, there are four experimental forms of the burger.\n\n1. The fat is unsaturated (stripped corn oil)\n2. The fat is saturated (lard)\n3. The fat is unsaturated and the diet also contains a beetroot extract at a concentration of 10g/100g.\n4. The fat is saturated and the diet also contains a beetroot extract at a concentration of 10g/100g.\n\nBeetroot (http://www.kanegrade.com/powders.htm) has been selected for the burger reformulation as it is a Scottish product rich in phytochemicals with potential antioxidant efficacy. An additional benefit may a blood pressure lowering effect. Initial taste tests indicate acceptable palatability.\n\nAll other components of the burger are formulated to be as similar as possible.\n\nFatty acid profiles and the "basic eight" used on food labels will be determined on the diets. Susceptibility of the diets to oxidise will be assessed using RANCIMAT.\n\nReady Meal Intervention:\n\nThis will be a latin square format whereby each volunteer consumes 4 treatments on separate occasions. This is a powerful design to assess whether incorporation of phytochemicals from Scottish products improves the health benefits of processed food as each volunteer acts as his/her own control. Volunteers will be randomly allocated to four groups\n\n* Treatment A High polyunsaturated (PUFA) ready meal (ie. burger)\n* Treatment B High saturated (SFA) fat ready meal\n* Treatment C High PUFA ready meal incorporating food extract\n* Treatment D High SFA ready meal incorporating food extract\n\nThere will be a washout period of at least 7 days between each treatment.\n\nVolunteers:\n\nHealthy volunteers aged 21 to 60 years will be recruited and attend HNU having fasted from 22.00h the previous evening on four test days. On arrival, they will be asked to provide a urine sample. The volunteers will then have a cannula inserted by a trained nurse and an initial baseline blood sample will be taken (volume 10 ml). The subjects will then be asked to consume the assigned breakfast within a 15 minute period. Water will be provided. Volunteers will then be requested to provide 10ml blood samples at 1h, 2h, 4h and 6h and 24 hrs. A 24 hr urine sample also will be obtained, starting the day of the test day. Blood pressure will be recorded at each time point.\n\nVolunteers will not be included if they\n\n* Are taking any medicines prescribed by their GP\n* Have a known allergy to beetroot\n* Are vegetarian or vegan\n* Regularly take nutritional supplements\n* Have given a large blood donation in last three months'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No diagnosed clinical condition\n\nExclusion Criteria:\n\nAre taking any medicines prescribed by their GP Have a known allergy to beetroot Are vegan Regularly take nutritional supplements Have given a large blood donation in last three months'}, 'identificationModule': {'nctId': 'NCT02169661', 'acronym': 'BABS', 'briefTitle': 'Burger and Beetroot Study - Lipid Oxidation Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'Lipid Oxidation of Ready Meals: Reformulation With Antioxidant Phytochemicals', 'orgStudyIdInfo': {'id': 'HNU 2000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Burger and Beetroot Study', 'interventionNames': ['Other: Burger and Beetroot Study']}], 'interventions': [{'name': 'Burger and Beetroot Study', 'type': 'OTHER', 'description': '50% fat, 10% beetroot extract', 'armGroupLabels': ['Burger and Beetroot Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB21 9SB', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Human Nutrition Unit, Rowett Institute of Nutrition and Health', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'Garry G Duthie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aberdeen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}