Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

Nutrient Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980094
• Other study ID #: 4921/2011
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: March 28, 2018
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Immunodeficiency
• Fatty Acid Deficiency
• Immunologic Deficiency Syndromes
• Institutionalization; Disinhibited Attachment
• Nutrient Deficiency
• Selenium Deficiency
• Vitamin E Deficiency

Intervention

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

Locations

Country	Name	City	State
Brazil	Clinics Hospital of the Ribeirao Preto Medical School	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eduardo Ferriolli

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Barr SI, McCarron DA, Heaney RP, Dawson-Hughes B, Berga SL, Stern JS, Oparil S. Effects of increased consumption of fluid milk on energy and nutrient intake, body weight, and cardiovascular risk factors in healthy older adults. J Am Diet Assoc. 2000 Jul;1 — View Citation

Bouis HE, Hotz C, McClafferty B, Meenakshi JV, Pfeiffer WH. Biofortification: a new tool to reduce micronutrient malnutrition. Food Nutr Bull. 2011 Mar;32(1 Suppl):S31-40. — View Citation

Kratz M, Baars T, Guyenet S. The relationship between high-fat dairy consumption and obesity, cardiovascular, and metabolic disease. Eur J Nutr. 2013 Feb;52(1):1-24. doi: 10.1007/s00394-012-0418-1. Epub 2012 Jul 19. Review. — View Citation

Witkowska Z, Michalak I, Korczynski M, Szoltysik M, Swiniarska M, Dobrzanski Z, Tuhy L, Samoraj M, Chojnacka K. Biofortification of milk and cheese with microelements by dietary feed bio-preparations. J Food Sci Technol. 2015 Oct;52(10):6484-92. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in profile of Inflammatory markers	Serum Cytokines measured in blood sample before and after to 12 weeks of milk supplementation	before and after 12 weeks
Other	Change in gene expression	Gene expression of cyclooxygenase -1 (COX-1) e-2, monocyte chemotactic protein (MCP-1), peroxisome proliferator-activated receptor (PPAR) (-d, -a and -ß / d) measured in blood sample before and after to 12 weeks milk supplementation	before and after 12 weeks
Other	Change in production of reactive oxygen species	Production of reactive oxygen species (ROS) produced by stimulated neutrophils measured in blood sample before and after to 12 weeks milk supplementation	before and after 12 weeks
Other	Change in phagocytic activity	Phagocytic activity measured in blood sample before and after to 12 weeks milk supplementation	before and after 12 weeks
Primary	Change in serum a-tocopherol	Assessment by blood sampling. Collect of a-tocopherol before and after to 12 weeks of milk supplementation	before and after 12 weeks
Primary	Change in serum selenium	Assessment by blood sampling. Collect of selenium before and after to 12 weeks milk supplementation	before and after 12 weeks
Primary	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	Assessment of nutritional status: food intake questionnaire	Food consumption questionnaire during the milk supplementation	before and after 12 weeks
Secondary	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
Secondary	Assessment of nutritional status: anthropometry (BMI)	BMI before and after 12 weeks of milk supplementation	before and after 12 weeks
Secondary	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
Secondary	Assessment demographics: questionnaire	Demographics questionnaire applied during the milk supplementation	before and after 12 weeks