Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

Eduardo Ferriolli

Status: Completed

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

Treatments: Dietary Supplement: Milk Antioxidant and oil(AO); Dietary Supplement: Milk Antioxidant group(A); Dietary Supplement: Milk Control group(C); Dietary Supplement: Milk Oil group(O)

Study type: Interventional

Funder types: Other

Identifiers

NCT02980094

4921/2011

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 60 to 110 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups, including a placebo group

Milk Control group(C)

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Milk Control group(C)

Milk Antioxidant group(A)

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Milk Antioxidant group(A)

Milk Oil group(O)

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Milk Oil group(O)

Milk Antioxidant and oil(AO)

Experimental group

Description:

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) .

Treatment:

Dietary Supplement: Milk Antioxidant and oil(AO)