CCRC: Understanding the Effects of Omega-3 Fatty Acids vs. Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Improved lipid profile
研究概览
简要总结
The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity.
We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).
Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG). Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and have been associated with cardiovascular benefits due to their antioxidant activity. Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high density lipoprotein (HDL-SAA).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or postmenopausal women in the 40-65 years age range. Body Mass Index in the range of 25-39
排除标准
- •Women are are premenopausal
- •Untreated thyroid disease
- •Kidney Disease
- •Liver Disease
- •Use of lipid lowering drugs
- •Use of insulin sensitizing drugs
- •Use of ACE inhibitors or other blood pressure lowering medications
- •Use of over the counter or prescription anti-obesity medications
- •Weight loss of 10% or more within the last 12 months
研究组 & 干预措施
Soybean oil bar
A nutrition bar enriched with soybean oil
干预措施: Flaxseed (Dietary Supplement)
Flaxseed bar with low lignans
A nutrition bar enriched with flaxseed oil
干预措施: Flaxseed (Dietary Supplement)
Flaxseed bars with high lignans
A nutrition bar enriched with flaxseed oil and high lignans
干预措施: Flaxseed (Dietary Supplement)
结局指标
主要结局
Improved lipid profile
时间窗: six weeks
次要结局
未报告次要终点
研究者
Sidika E. Karakas, MD
Professor
University of California, Davis