NCT02404207已完成不适用
The Effect of High-Oleic Soybean Oil on Biomarkers of Risk for Metabolic Syndrome
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: 2015年3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 lipid profile
研究概览
简要总结
The study will determine the effects of different types of soybean oils on biomarkers of risk for cardiovascular disease and diabetes. There will be four 4-week diet periods in which participants will consume the following oils, within the context of a controlled diet: soybean oil, high-oleic soybean oil, blend of high oleic soybean oil & fully hydrogenated soybean oil, and blend of palm olein & palm stearin.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30 to 70 years at beginning of study
- •LDL-cholesterol between 120 and 160 mg/dl
- •Less than 2+ risk factors for coronary heart disease (risk factors include: blood pressure > 140/90 mm Hg or on blood pressure medication; HDL-cholesterol < 40 mg/dl; age greater than 45 yrs for males & greater than 55 yrs for females; family history of premature coronary heart disease (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years)
排除标准
- •Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- •Use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
- •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 bariatric or certain other surgeries related to weight control
- •Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
- •Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
- •Smokers or other tobacco users (during 6 months prior to the start of the study)
- •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)
- •Known (self-reported) allergy or adverse reaction to study foods
- •Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months)
- •Unable or unwilling to give informed consent or communicate with study staff
- •Self-report of alcohol or substance abuse within the past 12 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 lipid profile
时间窗: At baseline and end of each 4-week diet period
Lipids and lipoproteins, such as total cholesterol, LDL-cholesterol, HDL-cholesterol, triacylglycerides, Apo AI, ApoAII, ApoB, apolipoprotein size, and cholesterol ester composition, will be measured in the blood.
次要结局
- Change in insulin(At baseline and end of each 4-week diet period)
- Change in vascular health(At baseline and end of each 4-week diet period)
- Change in waist circumference(At baseline and end of each 4-week diet period)
- Change in hemostasis(At baseline and end of each 4-week diet period)
- Change in oxidation(At baseline and end of each 4-week diet period)
- Change in glucose(At baseline and end of each 4-week diet period)
- Change in body composition(At baseline and end of each 4-week diet period)
- Change in systemic inflammation(At baseline and end of each 4-week diet period)
研究者
David Baer
Research Physiologist
USDA Beltsville Human Nutrition Research Center
研究点 (2)
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