Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

Not Applicable

Completed

• Conditions: Age-Related Immunodeficiency; Fatty Acid Deficiency; Nutrient Deficiency; Selenium Deficiency; Institutionalization; Disinhibited Attachment; Vitamin E Deficiency
• Interventions: Dietary Supplement: Milk Control group(C); Dietary Supplement: Milk Antioxidant group(A); Dietary Supplement: Milk Oil group(O); Dietary Supplement: Milk Antioxidant and oil(AO)

• Registration Number: NCT02980094
• Lead Sponsor: Eduardo Ferriolli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk Control group(C)	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.
Milk Antioxidant group(A)	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).
Milk Oil group(O)	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).
Milk Antioxidant and oil(AO)	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) .

Primary Outcome Measures

Name	Time	Method
Change in serum α-tocopherol	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	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	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinics Hospital of the Ribeirao Preto Medical School; 🇧🇷 Ribeirão Preto, São Paulo, Brazil