Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

NCT02980094 | Completed DMC

• 1 other identifier: 4921/2011
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

aging; nutrients; milk; dietary supplementation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Assessment of nutritional status: food intake questionnaire

  before and after 12 weeks

• Change in handgrip strength

  before and after 12 weeks

• Assessment of nutritional status: anthropometry (BMI)

  before and after 12 weeks

• Assessment of nutritional status: body composition

  before and after 12 weeks

• Assessment demographics: questionnaire

  before and after 12 weeks

Other Outcomes (4)

• Change in profile of Inflammatory markers

  before and after 12 weeks

• Change in gene expression

  before and after 12 weeks

• Change in production of reactive oxygen species

  before and after 12 weeks

Study Arms (4)

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.

Dietary Supplement: Milk Control group(C)

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).

Dietary Supplement: Milk Antioxidant group(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).

Dietary Supplement: Milk Oil group(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) .

Dietary Supplement: Milk Antioxidant and oil(AO)

Interventions

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).

Also known as: add control diet(C) in the cow's food, add selenium in the cow's food, add vitamin E in the cow's food

Milk Antioxidant group(A)

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).

Also known as: add control diet(C) in the cow's food, add sunflower oil group in the cow's food

Milk Oil group(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).

Also known as: 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

Milk Antioxidant and 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)

Also known as: 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

Milk Control group(C)

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any institution residents that use milk in their usual diet.

You may not qualify if:

• Inability to drink
• Use of enteral diets
• Lactose intolerance
• Autoimmune disorders
• Infections, allergies or inflammation in the two weeks prior to blood collection.

Sponsors & Collaborators

• Eduardo Ferriolli: lead

Study Sites (1)

Clinics Hospital of the Ribeirao Preto Medical School

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (5)

• 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.

  PMID: 10916520 RESULT

• 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.

  PMID: 21717916 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.

  PMID: 26396393 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.

  PMID: 22810464 RESULT

• 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.

  PMID: 29193757 DERIVED

MeSH Terms

Conditions

Vitamin E Deficiency

Interventions

Oils; Vitamin E; Selenium; Sunflower Oil

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lipids; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chalcogens; Elements; Inorganic Chemicals; Minerals; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Eduardo Ferriolli, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

• Helio Vannucchi, PhD

  Study Chair investigator

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: December 2, 2016
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 30, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)