InflammationIMAGINENCT02382458
Developing the Dietary Inflammatory Index for Clinical Application
A study testing Behavioral program to reduce inflammation in people with Inflammation, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Behavioral program to reduce inflammation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
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.
Read the 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.
- Conditions
- Inflammation
- Being tested
- Newsletters on cancer prevention and control, Behavioral program to reduce inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newsletters on cancer prevention and controlBehavioural
E-mailed or mailed newsletters that provide information on how to prevent cancer
Behavioral program to reduce inflammationBehavioural
Group classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Newsletters on cancer prevention and control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of inflammation assessed via blood samples
C-reactive protein
Measured: 12 weeks
Secondary outcomes (4)
Changes in body weight assessed via digital scales
Measured: 52 weeks
Changes in dietary intake assessed via three 24-hour dietary recalls
Measured: 52 weeks
Markers of inflammation assessed via blood samples
Measured: 52 weeks
Changes in body composition assessed via DXA
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMay 2015
- Primary completion28 Feb 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Brie Turner-McGrievy, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382458
- Sponsor's protocol ID
- Pro00037276
- Acronym
- IMAGINE
- Status last verified
- Apr 2019
- First submitted
- 13 Feb 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39492485Wirth 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.
PubMed 32406919Turner-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.
PubMed 30904228
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing the Dietary Inflammatory Index for Clinical Application
- ClinicalTrials.gov ID
- NCT02382458
- Acronym / sponsor ID
- IMAGINE / Pro00037276
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Behavioral program to reduce inflammationParticipants 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. |
| Information intervention | Active comparator | Behavioral: Newsletters on cancer prevention and controlParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Newsletters on cancer prevention and controlE-mailed or mailed newsletters that provide information on how to prevent cancer | Behavioural | Information intervention |
| Behavioral program to reduce inflammationGroup classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress | Behavioural | Lifestyle intervention |
Primary outcome
Markers of inflammation assessed via blood samples
Time frame: 12 weeks
C-reactive protein
4 secondary outcomes
Changes in body weight assessed via digital scales
Time frame: 52 weeks
Changes in dietary intake assessed via three 24-hour dietary recalls
Time frame: 52 weeks
Markers of inflammation assessed via blood samples
Time frame: 52 weeks
Changes in body composition assessed via DXA
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 39492485Wirth 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.
- Derived from this study: PubMed 32406919Wirth 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.
- Derived from this study: PubMed 30904228Turner-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brie Turner-McGrievy principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral program to reduce inflammation in people with Inflammation, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of inflammation assessed via blood samples (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02382458, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.