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Developing the Dietary Inflammatory Index for Clinical Application

Developing the Dietary Inflammatory Index for Clinical Application

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02382458
Acronym
IMAGINE
Enrollment
97
Registered
2015-03-06
Start date
2015-05-31
Completion date
2017-12-31
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Brief summary

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.

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.

Interventions

BEHAVIORALNewsletters on cancer prevention and control

E-mailed or mailed newsletters that provide information on how to prevent cancer

BEHAVIORALBehavioral program to reduce inflammation

Group classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress

Sponsors

University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Markers of inflammation assessed via blood samples12 weeksC-reactive protein

Secondary

MeasureTime frame
Changes in body weight assessed via digital scales52 weeks
Changes in dietary intake assessed via three 24-hour dietary recalls52 weeks
Markers of inflammation assessed via blood samples52 weeks
Changes in body composition assessed via DXA52 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026