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Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

NCT ID: NCT02980094

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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aging nutrients milk dietary supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Milk Control group(C)

Intervention Type 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)

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).

Group Type EXPERIMENTAL

Milk Antioxidant group(A)

Intervention Type 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).

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).

Group Type EXPERIMENTAL

Milk Oil group(O)

Intervention Type 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)

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) .

Group Type EXPERIMENTAL

Milk Antioxidant and oil(AO)

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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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 control diet(C) in the cow's food add sunflower oil group in the cow's food 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 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

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eduardo Ferriolli

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Ferriolli

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eduardo Ferriolli, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Helio Vannucchi, PhD

Role: STUDY_CHAIR

Study Chair investigator

Locations

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Clinics Hospital of the Ribeirao Preto Medical School

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 10916520 (View on PubMed)

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.

Reference Type RESULT
PMID: 21717916 (View on PubMed)

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.

Reference Type RESULT
PMID: 26396393 (View on PubMed)

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.

Reference Type RESULT
PMID: 22810464 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29193757 (View on PubMed)

Other Identifiers

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4921/2011

Identifier Type: -

Identifier Source: org_study_id