Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Modification of the postprandial inflammatory response.
研究概览
简要总结
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome.
详细描述
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome. If this extract is shown to mitigate the inflammatory response induced by a high fat meal, it could potentially aid in postponing of the diagnosis of diabetes or other chronic diseases associated with high levels of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The metabolic syndrome will be diagnosed on the basis of having a combination of any 3 of the following factors:
- •Waist circumference of ≥ 40 inches (men) or ≥ 35 inches (women)
- •Elevated triglycerides ≥150mg/dl
- •HDL cholesterol of < 40mg/dl (men) or < 50mg/dl (women)
- •Elevated blood pressure of ≥ 130/85mmHg
- •Fasting glucose of > 100mg/dL
- •Exclusion criteria:
- •Female subjects who are pregnant or lactating
- •Subjects taking any medications that would interfere with outcomes of the study i.e. lipid lowering medications, anti-inflammatory drugs (i.e. ibuprofen), dietary supplements
- •Subjects with any known allergy or intolerance to foods involved in the study (cantaloupe, egg, dairy, wheat, grape seed extract)
- •Subjects who are actively trying to lose weight
- •Subjects with unusual dietary habits (i.e. pica, anorexia nervosa, extreme food restriction, binging and/or purging disorders)
- •Subjects who are addicted to drugs or alcohol or who are <1 year recovery program
- •Subjects who present with significant psychiatric or neurological disturbances as determined by the primary investigator (i.e. uncontrolled bipolar disorder)
- •Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (≥ 140/90mmHg), liver and kidney disease as identified by routine blood tests (chemistry panels). These subjects will be referred to their primary care doctor for further care.
排除标准
- 未提供
研究组 & 干预措施
Grape seed extract
300mg of grape seed extract.
干预措施: Grape seed extract (Dietary Supplement)
Placebo
Sugar pill
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Modification of the postprandial inflammatory response.
时间窗: 7 hours
Analysis of inflammatory markers known to increase following a meal high in fat (\~40% kcal from fat). Markers to be analyzed will include the following: 1. Serum lipids 2. Oxidized LDL 3. Hs-CRP 4. TNFα 5. IL1 6. IL6
次要结局
- Metabolic response to a high fat meal.(7 hours)