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Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

Primary Purpose

Nutrient Deficiency, Age-Related Immunodeficiency, Vitamin E Deficiency

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Milk Antioxidant group(A)
Milk Oil group(O)
Milk Antioxidant and oil(AO)
Milk Control group(C)
Sponsored by
Eduardo Ferriolli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nutrient Deficiency focused on measuring aging, nutrients, milk, dietary supplementation

Eligibility Criteria

60 Years - 110 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinics Hospital of the Ribeirao Preto Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Milk Control group(C)

Milk Antioxidant group(A)

Milk Oil group(O)

Milk Antioxidant and oil(AO)

Arm Description

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.

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).

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).

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) .

Outcomes

Primary Outcome Measures

Change in serum α-tocopherol
Assessment by blood sampling. Collect of α-tocopherol before and after to 12 weeks of milk supplementation
Change in serum selenium
Assessment by blood sampling. Collect of selenium before and after to 12 weeks milk supplementation
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

Secondary Outcome Measures

Assessment of nutritional status: food intake questionnaire
Food consumption questionnaire during the milk supplementation
Change in handgrip strength
Measure of the hand grip strength using a portable dynamometer before and after 12 weeks of milk supplementation
Assessment of nutritional status: anthropometry (BMI)
BMI before and after 12 weeks of milk supplementation
Assessment of nutritional status: body composition
Body composition measured by multifrequency bioelectrical impedance analysis (BIA) before and after to 12 week of milk supplementation
Assessment demographics: questionnaire
Demographics questionnaire applied during the milk supplementation

Full Information

First Posted
November 9, 2016
Last Updated
March 28, 2018
Sponsor
Eduardo Ferriolli
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1. Study Identification

Unique Protocol Identification Number
NCT02980094
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eduardo Ferriolli

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrient Deficiency, Age-Related Immunodeficiency, Vitamin E Deficiency, Selenium Deficiency, Fatty Acid Deficiency, Institutionalization; Disinhibited Attachment
Keywords
aging, nutrients, milk, dietary supplementation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milk Control group(C)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Milk Antioxidant group(A)
Arm Type
Experimental
Arm Description
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).
Arm Title
Milk Oil group(O)
Arm Type
Experimental
Arm Description
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).
Arm Title
Milk Antioxidant and oil(AO)
Arm Type
Experimental
Arm Description
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) .
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk Antioxidant group(A)
Other Intervention Name(s)
add control diet(C) in the cow's food, add selenium in the cow's food, add vitamin E in the cow's food
Intervention Description
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
Intervention Name(s)
Milk Oil group(O)
Other Intervention Name(s)
add control diet(C) in the cow's food, add sunflower oil group in the cow's food
Intervention Description
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
Intervention Name(s)
Milk Antioxidant and oil(AO)
Other Intervention Name(s)
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
Intervention Description
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
Intervention Name(s)
Milk Control group(C)
Other Intervention Name(s)
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
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in serum α-tocopherol
Description
Assessment by blood sampling. Collect of α-tocopherol before and after to 12 weeks of milk supplementation
Time Frame
before and after 12 weeks
Title
Change in serum selenium
Description
Assessment by blood sampling. Collect of selenium before and after to 12 weeks milk supplementation
Time Frame
before and after 12 weeks
Title
Change in analysis of fatty acid profile
Description
Assessment by blood sampling. Collect of analysis of fatty acid profile before and after to 12 weeks of milk supplementation
Time Frame
before and after 12 weeks
Secondary Outcome Measure Information:
Title
Assessment of nutritional status: food intake questionnaire
Description
Food consumption questionnaire during the milk supplementation
Time Frame
before and after 12 weeks
Title
Change in handgrip strength
Description
Measure of the hand grip strength using a portable dynamometer before and after 12 weeks of milk supplementation
Time Frame
before and after 12 weeks
Title
Assessment of nutritional status: anthropometry (BMI)
Description
BMI before and after 12 weeks of milk supplementation
Time Frame
before and after 12 weeks
Title
Assessment of nutritional status: body composition
Description
Body composition measured by multifrequency bioelectrical impedance analysis (BIA) before and after to 12 week of milk supplementation
Time Frame
before and after 12 weeks
Title
Assessment demographics: questionnaire
Description
Demographics questionnaire applied during the milk supplementation
Time Frame
before and after 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in profile of Inflammatory markers
Description
Serum Cytokines measured in blood sample before and after to 12 weeks of milk supplementation
Time Frame
before and after 12 weeks
Title
Change in gene expression
Description
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
Time Frame
before and after 12 weeks
Title
Change in production of reactive oxygen species
Description
Production of reactive oxygen species (ROS) produced by stimulated neutrophils measured in blood sample before and after to 12 weeks milk supplementation
Time Frame
before and after 12 weeks
Title
Change in phagocytic activity
Description
Phagocytic activity measured in blood sample before and after to 12 weeks milk supplementation
Time Frame
before and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Ferriolli, PhD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helio Vannucchi, PhD
Organizational Affiliation
Study Chair investigator
Official's Role
Study Chair
Facility Information:
Facility Name
Clinics Hospital of the Ribeirao Preto Medical School
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10916520
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.
Results Reference
result
PubMed Identifier
21717916
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.
Results Reference
result
PubMed Identifier
26396393
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.
Results Reference
result
PubMed Identifier
22810464
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.
Results Reference
result
PubMed Identifier
29193757
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. Erratum In: Mol Nutr Food Res. 2018 May;62(10):e1870065.
Results Reference
derived

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Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

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