Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- inflammation
研究概览
简要总结
The purpose of this study is to to determine the effect of habituation to diets with different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular Disease (CVD) risk indicators with an emphasis on inflammation.
详细描述
Vegetable oils high in the specific fatty acids of interest - stearic (found in cocoa butter, meats), palmitic (found in meats, dairy and some plant oils) and stearic acid's metabolic product, oleic (found in olive and corn oil) - will be used to displace each other in a standardized diet and fed to mildly hypercholesterolemic postmenopausal women using a randomized-controlled crossover design. A critical issue remains unresolved - the relative comparability among . The findings from this research study will enable us to understand the mechanism and potential health effect of different types of fats. Each of the diet phases will be 5 weeks in length with a 2-4 week break between phases. All food and drink will be provided to study volunteers. Blood pressure and body weight will be monitored once per week and adjustments made, if necessary, to maintain a stable weight. During the 5th week of each diet phase, volunteers will come to the center on 3 consecutive days to provide fasting blood samples and a non-fasting blood sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The inclusion and exclusion criteria for both studies A and B are identical.
- •Postmenopausal women (menopause defined by complete natural cessation of menses for >12 months or a bilateral oophorectomy).
- •Age >50 to < 85 years
- •BMI >20 to <35 kg/m2
- •LDL-cholesterol >100 mg/dL
- •CRP <10 ug/dL
- •Normal fasting plasma glucose levels (<120 mg/dL)
- •Not taking medication known to affect lipid metabolism:
- •HMG-CoA reductase inhibitors (statins)
- •Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- •Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- •Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- •Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
- •Anticoagulants (Coumadin, Heparin, Plavix, etc)
- •Hormone therapy medications containing estrogen
- •Acetylsalicylic acid containing medications, aspirin
- •Diphenylhydantoin
- •Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) for at least 3 months prior to participation in the study
- •Anabolic steroids
- •Hydrocortisone
- •Normal kidney function as assessed by serum creatinine and blood urea nitrogen
- •Normal liver function as assessed by serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase and alkaline phosphatase
- •Normal thyroid function as assessed by serum TSH
- •Normal gastrointestinal function
- •Normotensive on or off medication
- •Non-smoker for at least 2 years
- •Alcohol intake < 7 drinks per week, and willingness to abstain from consuming alcohol while participating in the study.
- •Consistent physical activity
- •Willingness to follow protocol as detailed in the Institutional Review Board (IRB) approved consent form.
- •Exclusion criteria:
- •Women who have had a double mastectomy
- •Age < 50 and > 85 years
- •BMI < 20 and > 35 kg/m2
- •LDL-cholesterol <100 mg/dL
- •CRP > 10 ug/dL
- •Abnormal fasting plasma glucose levels >120 mg/dL
- •Use of medications known to affect lipid metabolism:
- •HMG-CoA reductase inhibitors (statins)
- •Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- •Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- •Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- •Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
- •Anticoagulants (Coumadin, Heparin, Plavix, etc)
- •Hormone therapy medications containing estrogen
- •Acetylsalicylic acid containing medications, aspirin
- •Diphenylhydantoin
- •Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) in the last 3 months prior to participation in the study
- •Anabolic steroids and hydrocortisone
- •Renal or kidney disease, as defined by a history of chronic kidney disease or by glomerular filtration rate of < 60 ml.min/1.73 m2 calculated from screening blood tests.
- •Hypothyroidism or hyperthyroidism, as defined as screening TSH outside of normal ranges (<0.4 or >4.5), unless controlled with medication for at least 6 months
- 另有 17 项未显示
排除标准
- 未提供
研究组 & 干预措施
oleic acid diet
Participants are provided with meals enriched in oleic acid (18:1)
干预措施: diet (Other)
palmitic acid diet
Participants are provided with meals enriched in palmitic acid (18:0)
干预措施: diet (Other)
stearic acid diet
Participants are provided with meals enriched in stearic acid (18:0)
干预措施: diet (Other)
结局指标
主要结局
inflammation
时间窗: 15-weeks
interleukine (IL)-6, tumor necrosis factor (TNF)-alpha, monocyte chemoattractant protein (MCP)-1, C-reactive protein (CRP), soluble forms of intercellular adhesion protein (slCAM)-1, vascular cell adhesion protein (sVCAM)-1, sE-selectin, sP-selectin and li0poprotein associated phospholipase A2 (LpPLA2).
次要结局
- insulin sensitivity(15 weeks)
- coagulation biomarkers(15 weeks)
- lymphocyte proliferation and ex vivo cytokine secretion(15 weeks)
- plasma lipids and lipoproteins(15 weeks)
- desaturase activity(15 weeks)