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临床试验/NCT03836651
NCT03836651已完成不适用

A Dietary Intervention to Reduce Inflammation and Oxidative Stress in Persons With Metabolic Syndrome

Martha Biddle2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2018年12月1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
94
试验地点
2
主要终点
Change in plasma C-reactive Protein (CRP) from baseline to one month.

研究概览

简要总结

Individuals diagnosed with metabolic syndrome are at a two-fold risk for developing cardiovascular disease. The investigators must identify strategies that can abort the development of cardiovascular disease. Inflammation and oxidative stress responsible for the pathogenesis of metabolic syndrome and CVD can be influenced by dietary changes. Strategic and novel interventions that include changing dietary patterns to include more antioxidant rich fruit and vegetables are pragmatic for primary prevention of CVD. Antioxidant rich fruits and vegetables, especially those with carotenoids (lycopene, lutein, zeaxanthin, alpha-carotene, and beta-carotene) have been efficacious in reducing the risk of CVD by decreasing inflammation and oxidative stress. The purpose of this study is to test the effect of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in persons diagnosed with metabolic syndrome. The sample will be randomized into one of two groups. Group one (intervention) will drink an 11.5 ounce serving of V8 100% vegetable juice once per day for 30 days. The second group (control) will continue to consume their normal diet. We will measure biomarkers of inflammation (C-reactive protein) and oxidative stress (malondialdehyde) in the two groups at baseline and the end of the 30-day intervention.

详细描述

SPECIFIC AIMS An estimated 47 million Americans have been diagnosed with metabolic syndrome. Glucose intolerance, abdominal obesity, hypertension and abnormal lipid profile are the identified traits of metabolic syndrome. Metabolic syndrome is a grouping of conditions that collectively are associated with a two-fold risk of cardiovascular disease (CVD). Inflammation and oxidative stress are contributing factors for the development of atherosclerotic plaque in CVD and are the initial pathological responses for each of the abnormal conditions associated with metabolic syndrome. Consequently, reducing inflammation and oxidative stress are considered appropriate targets for interventions designed for primary prevention of CVD and metabolic syndrome. Primary prevention is the fundamental strategy to reduce cardiovascular mortality. Given the high mortality rate associated with CVD and its vast impact on healthcare expenditures, it is imperative that the investigators develop novel interventions for primary prevention of CVD in persons with metabolic syndrome.

Interventions designed to address primary prevention are considered to be the most effective and logical strategy to improve health before the devastating burden of CVD becomes evident. There is an arsenal of CVD treatment modalities available today with many pharmacologic interventions, however, these come at an enormous cost to individuals and to our healthcare system. To address a gap in the treatment of CVD, nonpharmacologic interventions provide an alternative strategy without expense or undesirable adverse side effects. Simple, inexpensive dietary interventions can have a significant impact on an individual's health and are often overlooked by mainstream healthcare providers because of their simplicity. The impact of increasing fruit and vegetables, which are loaded with antioxidants, into a dietary pattern has consistently been supported in research and is recommended in all primary prevention guidelines. Yet, nine out of ten Americans get less than the recommended amounts of fruits and vegetables in their diet.

The purpose of this study is to test the effect of a dietary antioxidant intervention on inflammation and oxidative stress in individuals with metabolic syndrome. The study has the potential to reduce the incidence of cardiovascular disease. This proposal will address a major goal of Healthy People 2020: Improving cardiovascular health through prevention, detection, and treatment, specifically addressing primary prevention of CVD in individuals with metabolic syndrome.

Specific Aim #1: To test the effect of a dietary antioxidant intervention on biomarkers of inflammation and oxidative stress in individuals who have metabolic syndrome.

Hypothesis #1: Compared to a usual care control group and to their own baseline, individuals randomized to a dietary antioxidant intervention (30-day intake of V8® 100% Low-Sodium Vegetable juice) group will have lower levels of C-reactive protein (CRP) and malondialdehyde (MDA) at one month from baseline. CRP is a biomarker of inflammation and is an independent predictor of cardiovascular disease. MDA is the most prevalent byproduct of lipid peroxidation during oxidative stress and is considered an excellent measurement for use in clinical trials to evaluate oxidative stress.

研究设计

研究类型
Interventional
分配方式
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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects will be individuals who have a diagnosis of metabolic syndrome without overt CVD as defined by the National Cholesterol Education Program (NCEP) as evidenced by having at least 3 of the 5 following conditions:
  • Hypertension defined as SBP >130mmHg and diastolic >85mmHg
  • Abdominal obesity with a waist circumference greater than 88cm in women and greater than 102 cm in men
  • Triglycerides level greater than 150mg/dL
  • HDL levels less than 50mg/dL in women and less than 40mg/dL in men
  • Fasting glucose level greater than 100mg/dL Additional inclusion criteria include the ability to read and speak English, and have no cognitive impairment that precludes giving informed consent or ability to follow protocol instructions.

排除标准

  • Subjects will be excluded from the study if they: a) are less than 21 years of age; b) have a terminal illness; c) have impaired cognition; d) have a strong dislike, or have a potential food-drug interaction to V8® Low Sodium 100% vegetable juice; or e) co-existing illness documented in the medical record or self-reported associated with systemic inflammation (e.g. rheumatoid arthritis, acute systemic infection).

结局指标

主要结局

Change in plasma C-reactive Protein (CRP) from baseline to one month.

时间窗: Baseline and one month

Plasma will be collected at baseline and one month (up to 30 days) later for analysis of CRP. Data will be presented as the change over time between groups.

次要结局

  • Change in plasma Malondialdehyde (MDA) from baseline to one month.(Baseline and one month)

研究者

发起方
Martha Biddle
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Martha Biddle

Associate Professor

University of Kentucky

研究点 (2)

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