- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02382458
Developing the Dietary Inflammatory Index for Clinical Application (IMAGINE)
April 16, 2019 updated by: Brie Turner-McGrievy, University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Are ≥21 years of age;
- Are willing and able to participate fully in the study for a period of one year; and
- Are able to obtain travel to and from the intervention classes at the designated time.
Exclusion Criteria:
- 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;
- Any medications that are known to influence CRP levels such as chronic steroid (e.g., prednisone) use;
- 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);
- Actively receiving cancer treatment;
- Have had any major surgeries in the past 3 months;
- 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
- Life expectancy <3 years, on hospice, nursing home or other institutionalized care.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle intervention
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.
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Group classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress
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Active Comparator: Information intervention
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.
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E-mailed or mailed newsletters that provide information on how to prevent cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Markers of inflammation assessed via blood samples
Time Frame: 12 weeks
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C-reactive protein
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in body weight assessed via digital scales
Time Frame: 52 weeks
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52 weeks
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Changes in dietary intake assessed via three 24-hour dietary recalls
Time Frame: 52 weeks
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52 weeks
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Markers of inflammation assessed via blood samples
Time Frame: 52 weeks
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52 weeks
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Changes in body composition assessed via DXA
Time Frame: 52 weeks
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52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
February 28, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
February 13, 2015
First Submitted That Met QC Criteria
March 5, 2015
First Posted (Estimate)
March 6, 2015
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00037276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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