Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT02382458
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing the Dietary Inflammatory Index for Clinical Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Markers of inflammation assessed via blood samples', 'timeFrame': '12 weeks', 'description': 'C-reactive protein'}], 'secondaryOutcomes': [{'measure': 'Changes in body weight assessed via digital scales', 'timeFrame': '52 weeks'}, {'measure': 'Changes in dietary intake assessed via three 24-hour dietary recalls', 'timeFrame': '52 weeks'}, {'measure': 'Markers of inflammation assessed via blood samples', 'timeFrame': '52 weeks'}, {'measure': 'Changes in body composition assessed via DXA', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '39492485', 'type': 'DERIVED', 'citation': 'Wirth MD, Turner-McGrievy G, Shivappa N, Murphy EA, Hebert JR. Interaction between Meal-timing and Dietary Inflammatory Potential: Association with Cardiometabolic Endpoints in a 3-month Prospective Analysis. J Nutr. 2023 Oct 28;153(12):3555-64. doi: 10.1016/j.tjnut.2023.10.023. Online ahead of print.'}, {'pmid': '32406919', 'type': 'DERIVED', 'citation': 'Wirth MD, Jessup A, Turner-McGrievy G, Shivappa N, Hurley TG, Hebert JR. Changes in dietary inflammatory potential predict changes in sleep quality metrics, but not sleep duration. Sleep. 2020 Nov 12;43(11):zsaa093. doi: 10.1093/sleep/zsaa093.'}, {'pmid': '30904228', 'type': 'DERIVED', 'citation': 'Turner-McGrievy GM, Wirth MD, Shivappa N, Dunn CG, Crimarco A, Hurley TG, West DS, Hussey JR, Hebert JR. Impact of a 12-month Inflammation Management Intervention on the Dietary Inflammatory Index, inflammation, and lipids. Clin Nutr ESPEN. 2019 Apr;30:42-51. doi: 10.1016/j.clnesp.2019.02.008. Epub 2019 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'Diet plays a central role in the regulation of chronic inflammation. However, until the investigators developed the dietary inflammatory index (DII) there had been no scientifically valid way to relate what individuals eat to the capacity of foods consumed to modulate inflammation. The DII provides a tool that will form the basis of a counseling/instructional system aimed at helping patients and their providers to control chronic, systemic inflammation by improving the diet with specific, actionable dietary recommendations, counseling, and expert instruction. The goal of this study is to test the applicability of a DII mobile tool and associated counseling measures in clinical practice.', 'detailedDescription': 'A large, persuasive, and ever-increasing body of evidence links chronic inflammation to virtually all of the chronic diseases that cause the majority of disability and death in the U.S., including diabetes, cardiovascular diseases (CVD), and cancer. Diet plays a central role in the regulation of chronic inflammation. However, until the investigators developed the dietary inflammatory index (DII) there had been no scientifically valid way to relate what individuals eat to the capacity of foods consumed to modulate inflammation. The new generation DII has now produced an impressive research base that ranges from predicting blood levels of inflammatory markers, to clinical conditions associated with inflammation, to a variety of health-related endpoints including cancer incidence, CVDs and mortality (several of which are already published). Connecting Health Innovations (CHI), LLC and the scientific and clinical research partners at the University of South Carolina are committed to translating these research findings to places of clinical need and public health relevance. That commitment to translation provides the motivation for the current proposal. The DII provides a tool that will form the basis of a counseling/instructional system aimed at helping patients and their providers to control chronic, systemic inflammation by improving the diet with specific, actionable dietary recommendations, counseling, and expert instruction. This project is part of Phase II of the grant, which includes: 1) Designing and implementing an intervention trial based on DII response associated recommendations aimed at reducing levels of chronic inflammation in two diverse populations in Columbia, South Carolina and 2) Providing data for developing methods for commercialization/ dissemination of the product and associated software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are actively engaged as patients in the medical practices of University Specialty Clinics (under the direction of Dr. Victor Hirth) or Eau Claire Cooperative Health Care System (under the direction of Dr. Stuart Hamilton) or has physician consent\n* Are ≥21 years of age;\n* Are willing and able to participate fully in the study for a period of one year; and\n* Are able to obtain travel to and from the intervention classes at the designated time.\n\nExclusion Criteria:\n\n* Serious, unstable co-morbidity that would make participation in a diet and physical activity intervention difficult or risky including renal disease retinopathy, peripheral vascular disease or neuropathy;\n* Any medications that are known to influence CRP levels such as chronic steroid (e.g., prednisone) use;\n* Diagnoses of congestive heart failure, chronic renal failure, chronic liver disease (including alcoholic cirrhosis), cancer within the past year (except for non-melanoma skin cancer);\n* Actively receiving cancer treatment;\n* Have had any major surgeries in the past 3 months;\n* Poor performance status according to the World Health Organization definitions (i.e., Level 3: symptomatic, \\>50% in bed, capable of only limited self-care; or Level 4: bedbound); or\n* Life expectancy \\<3 years, on hospice, nursing home or other institutionalized care.'}, 'identificationModule': {'nctId': 'NCT02382458', 'acronym': 'IMAGINE', 'briefTitle': 'Developing the Dietary Inflammatory Index for Clinical Application', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Developing the Dietary Inflammatory Index for Clinical Application', 'orgStudyIdInfo': {'id': 'Pro00037276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle intervention', 'description': 'Participants will receive a year-long comprehensive, dietary, exercise, and stress management intervention. They will be asked to bring a partner of their choosing with them for support. The intervention will include a behavioral program to reduce inflammation.', 'interventionNames': ['Behavioral: Behavioral program to reduce inflammation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Information intervention', 'description': 'Participants will receive a year-long intervention that will involve receiving weekly (for the first 3 months) and then monthly (for the following 9 months) newsletters on cancer prevention and control (via e-mail or mail) that will provide the participant with information about cancer prevention and control strategies.', 'interventionNames': ['Behavioral: Newsletters on cancer prevention and control']}], 'interventions': [{'name': 'Newsletters on cancer prevention and control', 'type': 'BEHAVIORAL', 'description': 'E-mailed or mailed newsletters that provide information on how to prevent cancer', 'armGroupLabels': ['Information intervention']}, {'name': 'Behavioral program to reduce inflammation', 'type': 'BEHAVIORAL', 'description': 'Group classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress', 'armGroupLabels': ['Lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Brie Turner-McGrievy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brie Turner-McGrievy', 'investigatorAffiliation': 'University of South Carolina'}}}}