跳至主要内容
临床试验/NCT03158740
NCT03158740已完成不适用

A Watermelon Focused Dietary Inflammatory Index Counseling System to Reduce Systemic Inflammation

Michael D. Wirth2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
Change in C-reactive Protein

研究概览

简要总结

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).

详细描述

Study Objectives: Chronic inflammation underpins the development of numerous chronic diseases that contribute significantly to disability and mortality in the United States (US). Of particular interest, as it relates to inflammation, is diet which is a strong moderator of systemic inflammation. Diets high in fruit and vegetable intake, fish, and whole grains (e.g., Mediterranean and vegetarian diets) have been associated with lower levels of inflammation. On the other hand, diets rich in red meat, high-fat dairy products, and refined grains (Western diet) are typically associated with higher levels of inflammation. Up until 2014, no dietary index has been designed specifically to determine the inflammatory potential of individual's diet. However, researchers in the Cancer Prevention and Control Program, University of South Carolina developed the Dietary Inflammatory IndexTM (DII). The DII quantifies the level of dietary inflammatory potential on a scale from maximally anti- to pro-inflammatory. Watermelon is one of the fruits whose components have been shown to have anti-inflammatory effects. The overall objective of this proposal is to determine if a refined and modified watermelon-focused DII counselling system can reduce levels of chronic inflammation. The DII is a validated measure that has been shown to predict a range of outcomes including inflammation, cancer, CVD, and mortality, among others.

Specifically, the aims of this proposal are to:

  1. Refine and modify the DII-based intervention by developing and incorporating numerous watermelon recipes which will score low (anti-inflammatory) on the DII scale.
  2. Design and implement a two-arm intervention trial based on the refined watermelon-focused DII-based program for reducing levels of chronic inflammation. Each arm will have 15 participants (plus an additional 15 partners recruited by the intervention-arm participants). The intervention arm will receive the modified DII intervention whereas the control arm will receive general health education.

Justification: Include summary of prior work and expertise related to the topic and references cited: Until 2014 there had been no scientifically valid way to relate what individuals ate to the capacity of foods consumed to modulate inflammation. In response to the absence of an instrument that could summarize diets' ability to influence inflammatory processes, investigators developed the DII which is based on literature (nearly 2,000 peer-reviewed journal articles) on diet and inflammation through 2010.20 The DII categorizes individuals' diets according to their inflammatory potential. Additionally, it was found to predict changes in hs-CRP in the Seasonal Variation in Blood Cholesterol (SEASONS) Study. Subsequently, investigators have used the DII in about 100 datasets from around the world to test the effect of diet-associated inflammation on: 1) Inflammation markers such as CRP, IL-6, and TNF-alpha-R2; 2) CVD, 3) cancers of the breast, colon, prostate, ovary, endometrium, liver and pancreas; 3) all-cause, CVD and cancer-specific mortality; 4) respiratory conditions such as asthma; and 6) cognitive disorders. To date investigators have published more than 80 peer-reviewed DII publications.

Study Design Overview: Investigators have extensive experience with diet interventions spanning over two decades and involving a variety of endpoints including cancer, body weight, and those related to CVD, inflammation, and immune response. Intervention venues have ranged from the community (including worksites) and churches, research institute-based,to clinical practice sites. This study will include two study arms (i.e., intervention and control). Participants will be recruited from the community. Our goal is to recruit 15 participants per arm, in addition to enrolling partners (e.g., spouse, child, sibling) of intervention participants (n total = 45, n intervention = 30, n control = 15). Participants will undergo a baseline clinic, followed by twelve weeks of intervention classes, and then another clinic. The main intervention classes will take place at a state-of the-art demonstration kitchen located in the Cancer Prevention and Control Program at the University of South Carolina's Arnold School of Public Health.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in C-reactive Protein

时间窗: baseline and three months

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

次要结局

  • 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)

研究者

发起方
Michael D. Wirth
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael D. Wirth

Research Scientist

Connecting Health Innovation

研究点 (2)

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