Aronia Berry Supplementation for Improving Vascular Endothelial Dysfunction and Modulating the Gut Microbiota in Middle-Aged/Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption
研究概览
简要总结
Aging is the primary risk factor for cardiovascular disease (CVD) largely due to vascular endothelial dysfunction, a major initial step in the development of atherosclerosis. Endothelial dysfunction is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Interventions that improve endothelial dysfunction are important for improving endothelial function and reducing CVD risk in this high-risk population. Aronia melanocarpa, commonly known as aronia berries or chokeberries, are rich in polyphenols such as anthocyanins, proanthocyanidins, and phenolic acids. These compounds, and derivatives resulting from gut microbial and phase II metabolism, have been shown to attenuate oxidative stress and inflammation, and to improve endothelial function. Aronia berries and other berries have been shown in numerous studies to have diverse cardiometabolic health effects including modulation of endothelial function, arterial stiffness, blood pressure, oxidative stress, and inflammation. In addition, berries, dietary fiber, polyphenols have been shown to exert positive effects on the gut microbiota, which may mediate improvements in cardiovascular health. Recently, we have demonstrated that modulation of the gut microbiota is associated with improvements in vascular dysfunction. The primary goal of the currently proposed research is to assess the efficacy and dose-dependent response of an aronia full spectrum dietary supplement to improve endothelial function in middle-aged/older men and postmenopausal women. A secondary goal is to determine whether aronia full spectrum modulation of the gut microbiota is associated with improvements in endothelial function. Other functional and biochemical measures of cardiovascular health, oxidative stress, inflammation, and polyphenol metabolism will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and postmenopausal women (> 1 year from cessation of menstruation)
- •Aged 45-75 years
- •Baseline endothelial dysfunction (RHI ≤ 1.67)
- •Hemoglobin A1C ≤ 6.4%
- •Blood pressure < 129/80 mmHg
- •Total cholesterol < 240 mg/dL
- •LDL cholesterol < 190 mg/dL
- •Triglycerides < 350 mg/dLhttps://register.clinicaltrials.gov/prs/app/template/Home.vm?uid=U00036MD&ts=50&sid=S0008GBU&cx=gvt3fw
- •Body mass index ≥ 18.5 and < 30 kg/m2
- •Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- •Are able to understand the nature of the study
- •Able and willing to give signed written informed consent
- •Signed informed consent form
排除标准
- •Individuals taking antihypertensive, lipid-lowering, and/or hormone replacement medications
- •Diagnosed hypertension, CVD, diabetes, metabolic syndrome, cancer, kidney, liver, pancreatic disease
- •Obese participants, defined as BMI superior or equal to 30
- •Neuropathy, thrombosis, or past arm trauma or surgery
- •> 3 days/wk vigorous exercise
- •Participating in a weight loss program
- •Weight change > 5% in the past 3 months
- •Current smokers or history of smoking in the last 12 months
- •Heavy drinkers (> 7 drinks/wk for women; >14 drinks/wk for men)
- •Antibiotic use at any point during the study or two months prior to enrollment
- •Allergies to aronia berries or other study materials
- •Unwillingness to maintain normal diet and/or physical activity pattern, or to discontinue use of dietary supplements for the duration of the study
- •Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements
结局指标
主要结局
Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption
时间窗: Baseline and 6 weeks
Determine the effects on RHI measured by EndoPAT
次要结局
- Blood VCAM(Baseline and 6 weeks)
- Pulse wave velocity(Baseline and 6 weeks)
- Gut microbiota analysis(Baseline and 6 weeks)
- Blood pressure(Baseline and 6 weeks)
- Gastrointestinal health(Baseline and 6 weeks)
- Blood lipids(Baseline and 6 weeks)
- Blood hemoglobin A1c(Baseline and 6 weeks)
- Blood ICAM(Baseline and 6 weeks)
- Augmentation index(Baseline and 6 weeks)
- Blood oxidized LDL(Baseline and 6 weeks)