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Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980094
First Posted: December 2, 2016
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eduardo Ferriolli, University of Sao Paulo
  Purpose
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, 24 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, 100 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.

Condition Intervention
Nutrient Deficiency Age-Related Immunodeficiency Vitamin E Deficiency Selenium Deficiency Fatty Acid Deficiency Institutionalization; Disinhibited Attachment Dietary Supplement: Milk Antioxidant group(A) Dietary Supplement: Milk Oil group(O) Dietary Supplement: Milk Antioxidant and oil(AO) Dietary Supplement: Milk Control group(C)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Eduardo Ferriolli, University of Sao Paulo:

Primary Outcome Measures:
  • Change in serum α-tocopherol [ Time Frame: before and after 12 weeks ]
    Assessment by blood sampling. Collect of α-tocopherol before and after to 12 weeks of milk supplementation

  • Change in serum selenium [ Time Frame: before and after 12 weeks ]
    Assessment by blood sampling. Collect of selenium before and after to 12 weeks milk supplementation

  • Change in analysis of fatty acid profile [ Time Frame: before and after 12 weeks ]
    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 [ Time Frame: before and after 12 weeks ]
    Food consumption questionnaire during the milk supplementation

  • Change in handgrip strength [ Time Frame: before and after 12 weeks ]
    Measure of the hand grip strength using a portable dynamometer before and after 12 weeks of milk supplementation

  • Assessment of nutritional status: anthropometry (BMI) [ Time Frame: before and after 12 weeks ]
    BMI before and after 12 weeks of milk supplementation

  • Assessment of nutritional status: body composition [ Time Frame: before and after 12 weeks ]
    Body composition measured by multifrequency bioelectrical impedance analysis (BIA) before and after to 12 week of milk supplementation

  • Assessment demographics: questionnaire [ Time Frame: before and after 12 weeks ]
    Demographics questionnaire applied during the milk supplementation


Other Outcome Measures:
  • Change in profile of Inflammatory markers [ Time Frame: before and after 12 weeks ]
    Serum Cytokines measured in blood sample before and after to 12 weeks of milk supplementation

  • Change in gene expression [ Time Frame: before and after 12 weeks ]
    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

  • Change in production of reactive oxygen species [ Time Frame: before and after 12 weeks ]
    Production of reactive oxygen species (ROS) produced by stimulated neutrophils measured in blood sample before and after to 12 weeks milk supplementation

  • Change in phagocytic activity [ Time Frame: before and after 12 weeks ]
    Phagocytic activity measured in blood sample before and after to 12 weeks milk supplementation


Enrollment: 100
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980094


Locations
Brazil
Clinics Hospital of the Ribeirao Preto Medical School
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
Eduardo Ferriolli
Investigators
Principal Investigator: Eduardo Ferriolli, PhD Study Principal Investigator
Study Chair: Helio Vannucchi, PhD Study Chair investigator
  More Information

Publications:
Responsible Party: Eduardo Ferriolli, Assistant professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02980094     History of Changes
Other Study ID Numbers: 4921/2011
First Submitted: November 9, 2016
First Posted: December 2, 2016
Last Update Posted: December 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eduardo Ferriolli, University of Sao Paulo:
aging
nutrients
milk
dietary supplementation

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Vitamin E Deficiency
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Antioxidants
Selenium
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements