Developing the Dietary Inflammatory Index for Clinical Application

Inflammation Clinical Trial

— IMAGINE  

Official title:

Developing the Dietary Inflammatory Index for Clinical Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382458
• Other study ID #: Pro00037276
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2019
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 31, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation

Intervention

Behavioral:
• Newsletters on cancer prevention and control
E-mailed or mailed newsletters that provide information on how to prevent cancer
• Behavioral program to reduce inflammation
Group classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers of inflammation assessed via blood samples	C-reactive protein	12 weeks
Secondary	Changes in body weight assessed via digital scales		52 weeks
Secondary	Changes in dietary intake assessed via three 24-hour dietary recalls		52 weeks
Secondary	Markers of inflammation assessed via blood samples		52 weeks
Secondary	Changes in body composition assessed via DXA		52 weeks