Effects of Chardonnay Seed Flour on Vascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Endothelial function as measured by reactive hyperemia EndoPAT scores
研究概览
简要总结
This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form) with the purpose to test the impact of a four-month supplementation with Chardonnay Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and seeds. We will examine the effect of CSF on parameters such as endothelial function (via EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the makeup of and impact on the gut microbiome (via stool samples).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years old
- •Demonstrated endothelial dysfunction (EndoPAT score <= 2) at time of screening.
- •Exclusion criteria:
- •Age below 18 or above 80
- •Endothelial function greater than 2.0 at baseline
- •Hypertension (at screening): any patient with systolic blood pressure (SBP >=170 mmHg or diastolic blood pressure >= 110 mmHg, or hypotension (SBP < 100 mmHg
- •Abnormal liver function tests
- •Uncontrolled Diabetes Mellitus or the use of metformin for Diabetes Mellitus
- •Difficulty swallowing capsules
- •Gastrointestinal disease manifesting with symptoms of malabsorption such as celiac disease or Crohn's disease
- •Non-English speakers
- •Vulnerable populations unable to consent such as prisoners or dependents
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the CSF including, but not limited to, any of the following:
- •History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
- •Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
- •Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
- •History of hypersensitivity to any of the study supplement or suspected contraindications to the study supplement.
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol
排除标准
- 未提供
结局指标
主要结局
Endothelial function as measured by reactive hyperemia EndoPAT scores
时间窗: Baseline to 4 months
Endothelial function (Endothelial Peripheral Arterial Tonometry - EndoPAT) Testing will generate a score at baseline that will be compared to a second EndoPAT test which will be conducted again after the study subjects have taken the study product for 4 months. These scores will be used to determine if the study product had an effect on endothelial function.
次要结局
- Change in High Sensitive C-reactive protein (hsCRP)(Baseline to 4 months)