Investigation of the Relationship Between Alpha-linolenic Acid and Arterial, Biochemical, Biological Parameters in Older Persons With History of Cardiovascular Events and/or Moderate Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period
研究概览
简要总结
The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential of an adequate intake of alpha-linolenic acid in elderly.
详细描述
There is growing evidence that diets high in long chain n-3 polyunsaturated fatty acids (PUFA) decrease the risk of fatal ischemic heart disease.Both epidemiologic studies and clinical trials demonstrate substantial cardioprotective effects of alpha linolenic acid (ALA) from vegetable oils.However, little is known about the relation of the dietary intake of ALA with ischemic heart disease among older adults.In this study, elderly volunteers will be asked to ingest a supplement of a vegetable oil providing 1g of ALA, or an equivalent amount of linoleic acid as sunflower oil, for a diet period of 6 weeks.Serum samples will be collected before the dietary intervention and 6 weeks later.Plasma biomarkers of inflammatory, lipid cardiovascular risk factors and serum and red cell membrane fatty acid composition will be determined on all samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients over 65 years old exhibiting clinical indices of cardiovascular disease
- •Male or female
- •Subjects who were hospitalized in the Geriatric Unit of the Emile Roux Hospital (AP-HP)
- •MMSE (Mini Mental State Examination)score > or = 15
- •Supervision available for study medication
- •Able to ingest oral diet
排除标准
- •Patients unable to understand the objectives of the dietary intervention
- •Patients in paliative care
- •Patients receiving supplement diets
研究组 & 干预措施
Rapeseed arm
Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of rapeseed oil (with a high content in alpha-linolenic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with rapeseed oil (60% fat) that replaced butter on the breakfast toasts.
干预措施: Rapeseed oil (Dietary Supplement)
Sunflower arm
Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of sunflower oil (with a high content in linoleic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with sunflower oil (60% fat) that replaced butter on the breakfast toasts.
干预措施: Sunflower oil (Dietary Supplement)
结局指标
主要结局
Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period
时间窗: 6 weeks
Blood samples have been done at the beginning and at the end of the dietary period. Fatty acids analyses of the red cells and serum have been performed by GC method.
次要结局
- Others(6 weeks)
- Pulse wave velocity (PWV)(6 weeks)
研究者
Fathi Driss
Doctor
Assistance Publique - Hôpitaux de Paris