Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-02 @ 1:18 PM
Study NCT ID:
NCT01645995
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2012-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Reformulated Foods on Cardiovascular Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2012-07-18', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in body weight and body composition', 'timeFrame': '20 weeks. Baseline and week 8 assessments for two dietary intervention arms'}], 'secondaryOutcomes': [{'measure': 'Changes in energy and nutrient intake', 'timeFrame': '20 weeks. Run-in period and week 7 assessments for two dietary intervention arms'}, {'measure': 'Changes in appetite and mood ratings', 'timeFrame': '20 weeks. Run-in period and week 7 assessments for two dietary intervention arms', 'description': 'Subjective sensations of appetite and mood by visual analogue scale'}, {'measure': 'Changes in physical activity levels', 'timeFrame': '20 weeks. Run-in period and week 7 assessments for two dietary intervention arms', 'description': 'Measured by accelerometry'}, {'measure': 'Changes in fasting plasma lipid, insulin and glucose concentrations', 'timeFrame': '20 weeks. Baseline and week 8 assessments for two dietary intervention arms'}, {'measure': 'Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)', 'timeFrame': '20 weeks. Baseline and week 8 assessments for two dietary intervention arms'}, {'measure': 'Changes in cardiovascular risk factors (blood pressure, inflammatory markers)', 'timeFrame': '20 weeks. Baseline and week 8 assessments for two dietary intervention arms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Cardiovascular Disease', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '20470840', 'type': 'RESULT', 'citation': 'Reid M, Hammersley R, Duffy M. Effects of sucrose drinks on macronutrient intake, body weight, and mood state in overweight women over 4 weeks. Appetite. 2010 Aug;55(1):130-6. doi: 10.1016/j.appet.2010.05.001. Epub 2010 May 12.'}, {'pmid': '17217576', 'type': 'RESULT', 'citation': 'Reid M, Hammersley R, Hill AJ, Skidmore P. Long-term dietary compensation for added sugar: effects of supplementary sucrose drinks over a 4-week period. Br J Nutr. 2007 Jan;97(1):193-203. doi: 10.1017/S0007114507252705.'}]}, 'descriptionModule': {'briefSummary': 'Specific policies on obesity reduction often include a recommendation to reduce sugar consumption as a means of lowering overall caloric intake. Reformulating processed foods (e.g. sugary products) is considered one of the key options for improving population diet. The implications of regular consumption of reformulated products are not fully understood. Previous studies have demonstrated that dietary compensation is common, although the extent is not fully elucidated. In addition to the perceived impact of sugar consumption on weight control, high sugar intake, specifically sucrose and fructose, has been implicated in the increase of plasma lipids and markers of insulin resistance. However to date no randomised controlled study has investigated whether the consumption of reformulated low sugar products as components of a habitual diet have a significant impact on plasma lipid, insulin or glucose concentrations within a free-living, non-diseased population. It is hypothesised that exchange of reformulated, low sugar food products for habitually consumed foods will result in dietary compensation and minimal weight change compared with unmodified products and will have little impact on plasma glucose, insulin and lipid levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20 - 49 years\n* BMI 18.5 - 30 kg/m2\n* Plasma glucose \\<7 mmol/l (Not diagnosed with diabetes)\n* Plasma cholesterol \\<7 mmol/l\n* Plasma TAG \\<2.3 mmol/l\n* Normal liver and kidney function\n* Haemoglobin (\\>110 g/l women; 140g/dl men)\n\nExclusion Criteria:\n\n* Having suffered a myocardial infarction/stroke in the past 12 months\n* diabetic (diagnosed or fasting glucose \\> 7 mmol/l)\n* Smoking\n* On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation\n* Suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis\n* Excessive alcohol consumption\n* History of alcohol abuse\n* Following a reducing diet or vegan diet\n* Taking any fish oil, fatty acid or vitamin and mineral supplements\n* Participating in intensive aerobic activity for \\> 20 minutes 3 times per week\n* Food allergies\n* Anti-inflammatory usage'}, 'identificationModule': {'nctId': 'NCT01645995', 'acronym': 'REFORM', 'briefTitle': 'The Impact of Reformulated Foods on Cardiovascular Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': 'The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations', 'orgStudyIdInfo': {'id': '12/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reformulated products', 'description': 'Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks. Subjects were provided with reformulated beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.', 'interventionNames': ['Dietary Supplement: Reformulated products']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional products', 'description': 'Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks. Subjects were provided with conventional beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.', 'interventionNames': ['Dietary Supplement: Conventional products']}], 'interventions': [{'name': 'Reformulated products', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['REF'], 'description': 'Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks. Subjects were provided with reformulated beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.', 'armGroupLabels': ['Reformulated products']}, {'name': 'Conventional products', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CON'], 'description': 'Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks. Subjects were provided with conventional beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.', 'armGroupLabels': ['Conventional products']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 6AP', 'city': 'Reading', 'state': 'Berks', 'country': 'United Kingdom', 'facility': 'Department of Food and Nutritional Sciences, University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Prof Julie A Lovegrove, BSc, PhD, RNutr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Reading'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Metabolic Nutrition', 'investigatorFullName': 'Julie Lovegrove', 'investigatorAffiliation': 'University of Reading'}}}}