Clinical trial NCT02980094: Milk Biofortification Promotes Health Benefits in Institutionalized Elderly
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrient Deficiency
Age-Related Immunodeficiency
Vitamin E Deficiency
Selenium Deficiency
Fatty Acid Deficiency
Institutionalization; Disinhibited Attachment
Keywords: aging
nutrients
milk
dietary supplementation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 132
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in serum α-tocopherol
timeFrame: before and after 12 weeks
measure: Change in serum selenium
timeFrame: before and after 12 weeks
measure: Change in analysis of fatty acid profile
timeFrame: before and after 12 weeks
Secondary outcomes:
measure: Assessment of nutritional status: food intake questionnaire
timeFrame: before and after 12 weeks
measure: Change in handgrip strength
timeFrame: before and after 12 weeks
measure: Assessment of nutritional status: anthropometry (BMI)
timeFrame: before and after 12 weeks
measure: Assessment of nutritional status: body composition
timeFrame: before and after 12 weeks
measure: Assessment demographics: questionnaire
timeFrame: before and after 12 weeks
Other outcomes:
measure: Change in profile of Inflammatory markers
timeFrame: before and after 12 weeks
measure: Change in gene expression
timeFrame: before and after 12 weeks
measure: Change in production of reactive oxygen species
timeFrame: before and after 12 weeks
measure: Change in phagocytic activity
timeFrame: before and after 12 weeks
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinics Hospital of the Ribeirao Preto Medical School
state: São Paulo
Study officials:
affiliation: Study Principal Investigator
name: Eduardo Ferriolli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Chair investigator
name: Helio Vannucchi, PhD
role: STUDY_CHAIR
References:
citation: 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;100(7):810-7. doi: 10.1016/S0002-8223(00)00236-4.
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. doi: 10.1177/15648265110321S105.
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: 10.1007/s13197-014-1696-9. Epub 2015 Jan 21.
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.
citation: Pfrimer K, Ferriolli E, Takeuchi PL, Salles MS, Saran-Netto A, Zanetti MA, Roma-Junior LC, Braga CBM, Domenici FA, Valim YM, Paschoalato AB, Marchi LF, Azzolini AE, Donadi EA, Martinez E, Vannucchi H. Effects of the Consumption of Milk Biofortified with Selenium, Vitamin E, and Different Fatty Acid Profile on Immune Response in the Elderly. Mol Nutr Food Res. 2018 Feb;62(4). doi: 10.1002/mnfr.201700307. Epub 2018 Jan 15.