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Completed

NCT Number: NCT02382458

Developing the Dietary Inflammatory Index for Clinical Application

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Newsletters on cancer prevention and control

Behavioral

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

Behavioral program to reduce inflammation

Behavioral

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

Primary outcomes

  1. Markers of inflammation assessed via blood samples

    Time frame: 12 weeks

    C-reactive protein

Secondary outcomes

  1. Changes in body weight assessed via digital scales

    Time frame: 52 weeks

  2. Changes in dietary intake assessed via three 24-hour dietary recalls

    Time frame: 52 weeks

  3. Markers of inflammation assessed via blood samples

    Time frame: 52 weeks

  4. Changes in body composition assessed via DXA

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Acronym: IMAGINE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2015
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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