Developing the Dietary Inflammatory Index for Clinical Application

NCT02382458 | Completed

• 1 other identifier: Pro00037276
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Markers of inflammation assessed via blood samples

  C-reactive protein

  12 weeks

Secondary Outcomes (4)

• Changes in body weight assessed via digital scales

  52 weeks

• Changes in dietary intake assessed via three 24-hour dietary recalls

  52 weeks

• Markers of inflammation assessed via blood samples

  52 weeks

• Changes in body composition assessed via DXA

  52 weeks

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Behavioral program to reduce inflammation

Information intervention

ACTIVE COMPARATOR

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.

Behavioral: Newsletters on cancer prevention and control

Interventions

Newsletters on cancer prevention and control BEHAVIORAL

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

Information intervention

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

Lifestyle intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (3)

• 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: 39492485 DERIVED

• 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: 32406919 DERIVED

• 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.

  PMID: 30904228 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brie Turner-McGrievy

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: March 6, 2015
• Study Start: May 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: December 31, 2017
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)