Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT00733018
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2008-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D066273', 'term': 'Diet, Western'}, {'id': 'D018752', 'term': 'Diet, Fat-Restricted'}, {'id': 'D018753', 'term': 'Diet, Protein-Restricted'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2008-08-11', 'studyFirstSubmitQcDate': '2008-08-11', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in microarray gene expression profiles in blood from healthy young women and men, in response to western or balanced dietary macro nutrient composition.', 'timeFrame': 'Before and after each of two 6-days diet intervention periods'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers, hormonal dietary responses and blood lipids', 'timeFrame': 'Before and after each of two 6-days diet intervention periods'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nutrigenomics', 'Gene Expression', 'Diet, Carbohydrate-Restricted', 'Life Style', 'Health Behavior'], 'conditions': ['Cardiovascular Diseases', 'Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '21679058', 'type': 'BACKGROUND', 'citation': 'Brattbakk HR, Arbo I, Aagaard S, Lindseth I, de Soysa AK, Langaas M, Kulseng B, Lindberg F, Johansen B. Balanced caloric macronutrient composition downregulates immunological gene expression in human blood cells-adipose tissue diverges. OMICS. 2013 Jan;17(1):41-52. doi: 10.1089/omi.2010.0124. Epub 2011 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'Diet macronutrient relative composition, quality and quantity determines lifestyle disease, including cardiovascular disease, development. Our hypothesis is that a high content of carbohydrates in the diet contributes to increased insulin level. Moreover, activating enzymes promoting inflammatory processes and possibly chronic disease development in the body.', 'detailedDescription': 'The most frequent cause of death in both women and men in the western world is cardiovascular artery disease (CAD). Well accepted as a lifestyle disease, known risk factors for CAD development include changes in blood lipid content and type as well as micro inflammation in the arterial wall. Low density lipoprotein (LDL) and triglycerides are increased, high density lipoprotein (HDL) is reduced. Furthermore, type II diabetes, metabolic syndrome, hypertension, overweight, reduced physical activity and smoking also precede CAD development. Common for many of the risk factors is that they are induced by improper diet. Recent research has shown that especially total amount, composition and quality of the macro nutrients, protein, carbohydrate and fats, is important. In this project we will explore changes in blood gene expression in response to a western and a balanced crossover diet intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* BMI 24.5-27.5\n* pass health check criteria\n\nExclusion Criteria:\n\n* chronic diseases\n* inflammation\n* pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT00733018', 'acronym': 'Foodgene', 'briefTitle': 'Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development', 'orgStudyIdInfo': {'id': 'REK 4.2007.515'}, 'secondaryIdInfos': [{'id': '16649', 'type': 'OTHER', 'domain': 'NSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Diet A - Western diet', 'interventionNames': ['Behavioral: "Western" versus "balanced" macro nutrient diet composition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Diet B - Balanced diet', 'interventionNames': ['Behavioral: "Western" versus "balanced" macro nutrient diet composition']}], 'interventions': [{'name': '"Western" versus "balanced" macro nutrient diet composition', 'type': 'BEHAVIORAL', 'otherNames': ['western diet', 'high-carbohydrate, low fat, low protein diet', 'balanced diet', 'low-carbohydrate, high fat, high protein diet'], 'description': 'Randomized crossover diet intervention. 6 days on solely one of two isocaloric diets, 8 days washout, and then the other diet for 6 days. Fasting blood sampling before and after each diet intervention period.', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Berit Johansen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Sciense and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'FUGE Mid-Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}