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N/A N=23 Prevention

Watermelon Focused Dietary Inflammatory Index Intervention

Inflammation · Diet Modification

Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change in C-reactive Protein — -0.04; -0.56 mg/L

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
DII-Based Counseling System (Behavioral); general health education control (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Michael D. Wirth
Primary completion
Sep 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in C-reactive Protein
-0.04; -0.56
SECONDARY
Change in Haemoglobin A1C
0.00; -0.02
SECONDARY
Change in Glucose
-0.84; 4.29
SECONDARY
Change in BMI
-0.10; 0.13
SECONDARY
Change in Body Fat Percent
0.43; -0.77
SECONDARY
Change in Body Weight
-0.24; -0.14

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).

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03158740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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