Healthy Oils for Women: Reducing Visceral Adipose Tissue in Women with Metabolic Syndrome (HOW Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in trunk adipose mass
研究概览
简要总结
The purpose of this study is to understand the role of a dietary oil to alter chronic disease risk factors in women who are at risk for heart disease and/or diabetes. The investigator's previous study showed that safflower oil reduced trunk fat mass in women with diabetes. The investigators believe safflower oil can also attenuate criteria of metabolic syndrome through reduction in trunk fat mass.
详细描述
The long-term goal is to develop effective and novel dietary and lifestyle strategies to reduce the progression of metabolic syndrome to chronic diseases such as coronary heart disease. The rationale for conducting this research study is that there are few effective strategies that target changes in body composition and metabolism as a means to attenuate metabolic syndrome. The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims.
Specific Aim 1: Quantify the extent that linoleic acid reduces trunk adipose mass in women with metabolic syndrome.
Specific Aim 2: Measure changes in visceral adipose tissue
Specific Aim 3: Determine the time-dependent effect of linoleic acid to increase adiponectin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal (cessation of menses ≥12 months)
- •Age ≥ 50 and ≤ 69 years
- •At Least one of the following metabolic syndrome criteria
- •Elevated triglycerides (>150mg/dl)
- •Reduced HDL-C (<50mg/dl)
- •Elevated blood pressure (>130mm Hg systolic or > 85 mm Hg diastolic)
- •Elevated blood glucose (>100mg/dl and <126mg/dl)
- •Obese (BMI ≥ 30 kg/m² and ≤ 55 kg/m²)
- •Stable medical therapy for past 3 months
- •Stable body weight (within ± 2 kg) for past 3 months
- •Waist circumference >88cm (35 inches)
排除标准
- •Substance abuse
- •Current/previous diagnosis of type 2 diabetes or fasting blood glucose ≥126 mg/dL
- •Current use of medications or supplements known to affect body composition
- •Current or previous use of oral hypoglycemic agents or exogenous insulin.
- •Impaired cognitive function
- •Current or previous diagnosis of renal, heart, or circulatory disease
- •Gastrointestinal diseases or disorders
结局指标
主要结局
Changes in trunk adipose mass
时间窗: Baseline and Week 16 (end of the study)
次要结局
- Changes in lean mass(Baseline and Week 16 (end of the study))
- Changes in mood(Baseline through Week 16 (end of the study))
- Changes in glycemic control(Baseline through Week 16 (end of the study))
- Changes in visceral adipose tissue(Baseline and Week 16 (end of study))
- Changes in Lipid Profile(Baseline through Week 16 (end of the Study))
- Oil Supplementation Compliance(Baseline through Week 16 (end of the study))
- Changes in Alpha and Gamma Tocopherol Levels(Baseline through Week 16 (end of the study))
- Changes in adipocytokine levels(Baseline through Week 16 (end of the study))
研究者
Martha Belury
Carol S. Kennedy Professor of Nutrition
Ohio State University