Effects of Inclusion of Sunflower Oil, Vitamin E and Selenium in the Diet of Dairy Cows on Milk Composition and Its Influence on Nutrition and Health of Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Change in serum α-tocopherol
研究概览
简要总结
The project aims to study the effects of inclusion of sunflower oil, vitamin E and selenium in the diet of dairy cows on milk composition and the influence of modified milk on nutrition and health of elderly. To achieve those goals, two experiments will be conducted, both lasting 12 weeks. In the first one, 32 cows at the beginning of lactation will be allotted in a completely randomized block design with a 2 x 2 factorial arrangement of treatments, as follow: 1) control diet; 2) control diet plus selenium and vitamin E; 3) control diet plus sunflower oil diet; 4) control diet plus sunflower oil, selenium and vitamin E. This experiment seeks the development of modified milks through nutritional manipulation of cow's diet. Concomitantly, in the second experiment, 132 elderly people will receive the four different kinds of milk produced in the first experiment in a completely randomized block (gender) design. The selection of the elderly for each group shall be composed clinical evaluations. Will be conducted biochemical tests before and after supplementation of milk consumption (serum α-tocopherol, selenium, analysis of fatty acid profile). Assessment of nutritional status will be made body mass index (BMI) with each participant before and after the experiment of 12 weeks, including body composition by multifrequency bioelectrical impedance analysis (BIA), evaluating the strength of pressure of the hand portable dynamometer, demographics and food consumption. The study of human nutrition and health will be held in the form of a double-blind study. The second experiment aims to study nutrition and health of elderly people, as it is expected that milk produced with better fatty acid profile, vitamin and minerals can improve the inflammatory profile of markers of the elderly. This project is important for the human population in general, particularly elderly people, health workers, human and animal nutritionists, and especially for the milk chain, as it has a potential to develop new dairy products and boost milk consumption.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any institution residents that use milk in their usual diet.
排除标准
- •Inability to drink
- •Use of enteral diets
- •Lactose intolerance
- •Autoimmune disorders
- •Infections, allergies or inflammation in the two weeks prior to blood collection.
研究组 & 干预措施
Milk Control group(C)
Using a randomized block design, 25 institutionalized elderly to receive the milk 3 times per day produced by lactating cows fed with the following diet, one of the group is control (C), without vitamin E, selenium, sunflower oil in the cow's food.
干预措施: Milk Control group(C) (Dietary Supplement)
Milk Antioxidant group(A)
Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diet: control (C) +vitamin E+ selenium (A).
干预措施: Milk Antioxidant group(A) (Dietary Supplement)
Milk Oil group(O)
Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diets: control (C)+sunflower oil (O).
干预措施: Milk Oil group(O) (Dietary Supplement)
Milk Antioxidant and oil(AO)
Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diets: control C+sunflower oil+vitamin E+selenium (AO) .
干预措施: Milk Antioxidant and oil(AO) (Dietary Supplement)
结局指标
主要结局
Change in serum α-tocopherol
时间窗: before and after 12 weeks
Assessment by blood sampling. Collect of α-tocopherol before and after to 12 weeks of milk supplementation
Change in serum selenium
时间窗: before and after 12 weeks
Assessment by blood sampling. Collect of selenium before and after to 12 weeks milk supplementation
Change in analysis of fatty acid profile
时间窗: before and after 12 weeks
Assessment by blood sampling. Collect of analysis of fatty acid profile before and after to 12 weeks of milk supplementation
次要结局
- Assessment of nutritional status: body composition(before and after 12 weeks)
- Assessment of nutritional status: food intake questionnaire(before and after 12 weeks)
- Assessment of nutritional status: anthropometry (BMI)(before and after 12 weeks)
- Change in handgrip strength(before and after 12 weeks)
- Assessment demographics: questionnaire(before and after 12 weeks)
研究者
Eduardo Ferriolli
Assistant professor
University of Sao Paulo