Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

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

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.

Study Overview

• Status: Completed
• Conditions: Fatty Acid Deficiency; Nutrient Deficiency; Vitamin E Deficiency; Selenium Deficiency; Age-Related Immunodeficiency; Institutionalization; Disinhibited Attachment
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Clinics Hospital of the Ribeirao Preto Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: 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); Other Names: add control diet (C) in the cow's food; without vitamin E in the cow's food; without selenium in the cow's food; without sunflower oil in the cow's food
Experimental: 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).	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).; Other Names: add control diet(C) in the cow's food; add selenium in the cow's food; add vitamin E in the cow's food
Experimental: 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).	Dietary supplement: 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).; Other Names: add control diet(C) in the cow's food; add sunflower oil group in the cow's food
Experimental: 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) .	Dietary supplement: 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).; Other Names: add control diet(C) in the cow's food; add selenium in the cow's food; add vitamin E in the cow's food; add sunflower oil in the cow's food

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in gene expression	Gene expression of cyclooxygenase -1 (COX-1) e-2, monocyte chemotactic protein (MCP-1), peroxisome proliferator-activated receptor (PPAR) (-δ, -α and -β / δ) measured in blood sample before and after to 12 weeks milk supplementation	before and after 12 weeks
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
Change in phagocytic activity	Phagocytic activity measured in blood sample before and after to 12 weeks milk supplementation	before and after 12 weeks

Collaborators and Investigators

• Sponsor: Eduardo Ferriolli
• Investigators: Principal Investigator: Eduardo Ferriolli, PhD, Study Principal Investigator; Study Chair: Helio Vannucchi, PhD, Study Chair investigator

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Mol Nutr Food Res. 2018 May;62(10):e1870065.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: dietary supplementation; aging; milk; nutrients
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin E Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Antioxidants; Tocotrienols; Selenium
• Other Study ID Numbers: 4921/2011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO