Watermelon Focused Dietary Inflammatory Index Intervention

NCT03158740 | Completed Results

• 1 other identifier: 123
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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 investigators developed the Dietary Inflammatory Index (DII)TM there had been no scientifically valid way to relate what individuals eat to the capacity of foods consumed to modulate inflammation. The DII has now produced an impressive research base that ranges from predicting blood levels of inflammatory biomarkers; to a variety of health-related endpoints including cancer incidence and mortality, diabetes, and CVD; to psychological endpoints including depression and cognitive functioning. Watermelon is a member of the Cucurbitaceae family of gourds and is related to the cucumber, squash, and pumpkin. Watermelon flesh (WM) is \~91% water by weight, and is a rich source of bioavailable compounds including lycopene and other carotenoids, and vitamins A and C, all of which have anti-inflammatory properties. Watermelon is already known to play an effective role in reducing risk of chronic inflammation related conditions like coronary heart disease. Connecting Health Innovations (CHI) through this proposal is committed to developing a watermelon supplemented dietary intervention to reduce 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. Our first aim is to refine and modify the DII-based intervention by developing and incorporating several watermelon recipes which will score low (anti-inflammatory) on the DII scale. Our second aim is to design and implement a two-arm intervention trial based on watermelon-focused DII recommendations aimed at reducing levels of chronic inflammation in Columbia, South Carolina; the two arms of this intervention study will be the DII-Based Counseling System, including access to our Imagine Healthy Online Portal, and a general health education control. Data will include questionnaires (e.g., demographics, health history, stress, depression, self-efficacy for physical activity and diet, social approval, social desirability), anthropometrics measures, physical activity monitoring, inflammatory marker C-reactive protein (CRP), and ASA 24-hour dietary recalls. Baseline data collection will be followed by a 12-week intervention period. The DII arm will receive in-person healthy cooking and nutrition classes, along with physical activity and stress reduction activities. Additionally, this arm will receive access to the Imagine Healthy Online Portal. The general health control arm will receive weekly health education information. Linear mixed models (LMM) will be used to determine whether the intervention arms are associated with the primary outcome (i.e., CRP).

Conditions

Inflammation; Diet Modification

Outcome Measures

Primary Outcomes (1)

• Change in C-reactive Protein

  Investigators will examine if there is a change in the levels of CRP from baseline to 3 months.

  baseline and three months

Secondary Outcomes (5)

• Change in Haemoglobin A1C

  baseline and three months

• Change in Glucose

  Baseline to 3 months

• Change in BMI

  Baseline to 3 months

• Change in Body Fat Percent

  baseline to 3 months

• Change in Body Weight

  baseline to 3 months

Study Arms (2)

DII-Based Counseling System

ACTIVE COMPARATOR

The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. Participants will have access to online material through our Imagine Healthy Online Portal and will be given take-home activities, referred to as IMAGINE actions. These homework assignments will focus on goal setting for nutrition, physical activity, and stress reduction. The nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components.

Behavioral: DII-Based Counseling System

general health education control

ACTIVE COMPARATOR

The standard of care arm will receive general health information (e.g., general guidelines of healthy eating and physical activity, stress management, cancer screening, etc.). This information will be provided through email, which will include a weekly newsletter, healthy recipes that are not focused on reducing the DII scores, links to online content, and health-related event announcements in and around Columbia, SC.

Behavioral: general health education control

Interventions

DII-Based Counseling System BEHAVIORAL

DII-Based Counseling System, including 12 weekly classes in reducing inflammation by adopting dietary patterns low in inflammation and also through physical activity and stress reduction. Participants will also have access to our Imagine Healthy Online Portal. Group-based behavior change programs provide a way for members to share successes and obtain and provide support to one another.

DII-Based Counseling System

general health education control BEHAVIORAL

The standard of care arm will receive general health information (e.g., general guidelines of healthy eating and physical activity, stress management, cancer screening, etc.). This information will be provided through email, which will include a weekly newsletter, healthy recipes that are not focused on reducing the DII scores, links to online content, and health-related event announcements in and around Columbia, SC. Any participants in the standard of care arm who does not use email regularly may request for items to be mailed to their mailing address.

general health education control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are ≥18 years of age;
• have a BMI between 25.0-49.9 kg/m2;
• Participants also will have no serious, unstable co-morbidity that would make participation in a diet and PA intervention difficult or risky;
• live in or near the Columbia, SC area;
• have access to the Internet, a computer, a smartphone, and a valid email address;
• are not pregnant or planning on becoming pregnant;
• are not currently enrolled in a weight-loss study or are actively taking weight-loss medications; and
• are willing and able to participate fully in the study for a period of one year.

You may not qualify if:

• congestive heart failure;
• chronic renal failure;
• chronic liver disease, including alcoholic cirrhosis;
• a diagnosis of cancer within the past year, except for non-melanoma skin cancer;
• actively receiving cancer treatment;
• poor performance status (e.g., non-ambulatory); or
• life expectancy \<3 years, on hospice, nursing home or other institutionalized care. Individuals will be screened at the clinical practice site(s) to ensure that they meet all of the eligibility criteria and have none of the ineligibility criteria.

Sponsors & Collaborators

• Michael D. Wirth: lead
• National Watermelon Promotion Board: collaborator

Study Sites (1)

Connecting Health Innovations

Columbia, South Carolina, 29250, United States

Location

Related Publications (3)

• Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.

  PMID: 23941862 RESULT

• Shivappa N, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Tabung F, Hebert JR. A population-based dietary inflammatory index predicts levels of C-reactive protein in the Seasonal Variation of Blood Cholesterol Study (SEASONS). Public Health Nutr. 2014 Aug;17(8):1825-33. doi: 10.1017/S1368980013002565. Epub 2013 Oct 10.

  PMID: 24107546 RESULT

• Wirth MD, Shivappa N, Khan S, Vyas S, Beresford L, Sofge J, Hebert JR. Impact of a 3-Month Anti-inflammatory Dietary Intervention Focusing on Watermelon on Body Habitus, Inflammation, and Metabolic Markers: A Pilot Study. Nutr Metab Insights. 2020 Jan 13;13:1178638819899398. doi: 10.1177/1178638819899398. eCollection 2020.

  PMID: 31975781 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Scientist
• Organization: Connecting Health Innovations

admin@chi-llc.net

8649154636

Study Officials

• Nitin Shivappa, Phd

  Connecting Health Innovation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist

Model Details: The two arms of this intervention study will be the DII-Based Counseling System, including access to our Imagine Healthy Online Portal, and a general health education control. Group-based behavior change programs provide a way for members to share successes and obtain and provide support to one another. Both arms will be composed of 1 wave of 15 individuals. Participants will be required to invite a partner of their choosing to join them in the intervention activities to improve social support for behavioral change. Investigators have experience conducting studies where participants invite partners to participate.

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: June 7, 2017
• Primary Completion: September 7, 2017
• Study Completion: September 14, 2017
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-10

Locations

US (1)