NCT01595607已完成不适用
The Influence of Daily Consumption of Avocado on Biomarkers of Vascular Health
USDA Beltsville Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年4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
- 60
- 试验地点
- 2
- 主要终点
- Change in Endothelial Function
研究概览
简要总结
The study will investigate the effect of avocado consumption on markers of vascular health. Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be utilized. Participants will either receive a typical American diet, or a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat, to allow the isoenergetic inclusion of avocado.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 28 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 25 and 42 kg/m2
- •Age 28 to 70 years during the intervention
- •Fasting glucose ≤ 126 mg/dl
- •Blood pressure ≤ 160/100 mm Hg
排除标准
- •Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes
- •Women who have given birth during the previous 12 months
- •Pregnant women or women who plan to become pregnant or become pregnant during the study
- •Lactating women
- •Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- •History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- •Volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study.
- •Volunteers who have lost 10% of body weight within the last 12 months
- •Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity
- •Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
- •Smokers or other tobacco users (during the 6 months prior to the start of the study)
- •Unable or unwilling to give informed consent or communicate with study staff
- •Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion.)
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
结局指标
主要结局
Change in Endothelial Function
时间窗: 0 hr and 3 hr at baseline and after 6 weeks
Noninvasive endothelial function will be assessed, following a 12-hours fast, by measuring endothelium-dependent flow mediated dilation of the peripheral bed. Participants will then consume a test meal and endothelial function will be assessed again 3 hours later.
次要结局
- Change in Blood Pressure(Baseline and after 6 weeks)
- Change in Biomarkers of Cardiovascular Disease Risk(Baseline and after 6 weeks)
- Change in Gene Expression(Baseline and after 6 weeks)
研究者
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center
研究点 (2)
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