Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nutrient Deficiency, Age-Related Immunodeficiency, Vitamin E Deficiency, Selenium Deficiency, Fatty Acid Deficiency, Institutionalization; Disinhibited Attachment

Intervention / Treatment
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* Dietary Supplement: Milk Antioxidant group(A)
* Dietary Supplement: Milk Oil group(O)
* Dietary Supplement: Milk Antioxidant and oil(AO)
* Dietary Supplement: Milk Control group(C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any institution residents that use milk in their usual diet. Exclusion Criteria: Inability to drink Use of enteral diets Lactose intolerance Autoimmune disorders Infections, allergies or inflammation in the two weeks prior to blood collection.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Milk Control group(C)<br>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. | Dietary Supplement: Milk Control group(C)<br>* There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)<br>* Other names: without sunflower oil in the cow's food;|
| Experimental: Milk Antioxidant group(A)<br>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). | Dietary Supplement: Milk Antioxidant group(A)<br>* There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)+selenium and vitamin E (A).<br>* Other names: add vitamin E in the cow's food;|
| Experimental: Milk Oil group(O)<br>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). | Dietary Supplement: Milk Oil group(O)<br>* There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)+sunflower oil (O).<br>* Other names: add sunflower oil group in the cow's food;|
| Experimental: Milk Antioxidant and oil(AO)<br>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) . | Dietary Supplement: Milk Antioxidant and oil(AO)<br>* There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets:control (C)+selenium, vitamin E and sunflower oil (AO).<br>* Other names: add sunflower oil in the cow's food;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum α-tocopherol | Assessment by blood sampling. Collect of α-tocopherol before and after to 12 weeks of milk supplementation | before and after 12 weeks | 
| Change in serum selenium | Assessment by blood sampling. Collect of selenium before and after to 12 weeks milk supplementation | before and after 12 weeks | 
| Change in analysis of fatty acid profile | Assessment by blood sampling. Collect of analysis of fatty acid profile before and after to 12 weeks of milk supplementation | before and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of nutritional status: food intake questionnaire | Food consumption questionnaire during the milk supplementation | before and after 12 weeks | 
| Change in handgrip strength | Measure of the hand grip strength using a portable dynamometer before and after 12 weeks of milk supplementation | before and after 12 weeks | 
| Assessment of nutritional status: anthropometry (BMI) | BMI before and after 12 weeks of milk supplementation | before and after 12 weeks | 
| Assessment of nutritional status: body composition | Body composition measured by multifrequency bioelectrical impedance analysis (BIA) before and after to 12 week of milk supplementation | before and after 12 weeks | 
| Assessment demographics: questionnaire | Demographics questionnaire applied during the milk supplementation | before and after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aging, nutrients, milk, dietary supplementation