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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk Control group(C) | Placebo Comparator | 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) | Experimental | 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) | Experimental | 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) | Experimental | 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) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk Antioxidant group(A) | Dietary Supplement | 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). |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Ferriolli, PhD | Study Principal Investigator | Principal Investigator |
| Helio Vannucchi, PhD | Study Chair investigator | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinics Hospital of the Ribeirao Preto Medical School | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10916520 | Result | 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. | |
| 21717916 | Result |
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|
|
| Milk Oil group(O) | Dietary Supplement | 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) | Dietary Supplement | 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) | Dietary Supplement | 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) |
|
|
| 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 |
| 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 |
| 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. |
| 26396393 | Result | 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. |
| 22810464 | Result | 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. |
| 29193757 | Derived | 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. |
| ID | Term |
|---|---|
| D014811 | Vitamin E Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009821 | Oils |
| D014810 | Vitamin E |
| D012643 | Selenium |
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D008055 | Lipids |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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