Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task
研究概览
简要总结
The purpose of this study is to assess whether feeding highly antioxidant spices of providing these same antioxidants as capsules is able to affect cardiovascular risk measures. Because this is a new area of research, the investigators will use many measures to assess this question including blood markers, tests of blood vessel health, measures of blood pressure responses, measures of clotting activity, and other inflammation measures.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30-65
- •BMI 25-40
- •Non tobacco user
- •Resting BP < 160/100
- •Fasting Glucose < 126 mg/dL
排除标准
- •Tobacco use
- •Use of female hormones
- •Breastfeeding or planning to become pregnant during the study
- •Use of lipid-lowering or blood pressure medications
- •Chronic Inflammatory Disease or osteoarthritis requiring regular use of medication
- •Chronic use of any form of anti-inflammatory or anti-psychotic drugs
- •Use of daily aspirin or supplements (except stable dose of calcium)
- •History of heart attack or stroke, renal or hepatic disease, implanted medical devices, gastrointestinal disease
- •Allergy or intolerance to any study foods
- •Injury to fingers or arms that would interfere with vascular and blood pressure measurements
- •Inability to comply with study protocol
- •Allergy to adhesives or latex
- •Aerobic exercise exceeding 2 hours per week
研究组 & 干预措施
No Spice, Stress
Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
干预措施: Trier Psychological Stressor (Behavioral)
No Spice, Stress
Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
干预措施: Placebo antioxidant concentrate (Other)
Spice, no stress
干预措施: High Antioxidant Spice Blend (Dietary Supplement)
Spice and Stress
干预措施: High Antioxidant Spice Blend (Dietary Supplement)
Spice and Stress
干预措施: Trier Psychological Stressor (Behavioral)
No spice, no stress
Subject are given placebo capsules and told they contain an antioxidant concentrate
干预措施: Placebo antioxidant concentrate (Other)
结局指标
主要结局
IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task
时间窗: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
次要结局
- Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes(At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal)
- Endothelial function measured by endopat(At baseline and 3.5 hours following the meal)
- Platelet function measured by PFA-100(At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal)
研究者
Sheila G West
Professor of Biobehavioral Health
Penn State University