Developing the Dietary Inflammatory Index for Clinical Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Markers of inflammation assessed via blood samples
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lifestyle intervention
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.
干预措施: Behavioral program to reduce inflammation (Behavioral)
Information intervention
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.
干预措施: Newsletters on cancer prevention and control (Behavioral)
结局指标
主要结局
Markers of inflammation assessed via blood samples
时间窗: 12 weeks
C-reactive protein
次要结局
- 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)
研究者
Brie Turner-McGrievy
Associate Professor
University of South Carolina