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Completed

NCT Number: NCT02980094

Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

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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Key information

Conditions

Nutrient Deficiency Age-Related Immunodeficiency Avitaminosis Deficiency Diseases Fatty Acid Deficiency Institutionalization; Disinhibited Attachment Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Selenium Deficiency Vitamin E Deficiency

Age range

60 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinics Hospital of the Ribeirao Preto Medical School

Ribeirão Preto, São Paulo, 14048-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

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).

Other names: add control diet(C) in the cow's food, add sunflower oil group in the cow's food

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).

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

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)

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

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Assessment of nutritional status: food intake questionnaire

    Time frame: before and after 12 weeks

    Food consumption questionnaire during the milk supplementation

  2. 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

  3. Assessment of nutritional status: anthropometry (BMI)

    Time frame: before and after 12 weeks

    BMI before and after 12 weeks of milk supplementation

  4. 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

  5. Assessment demographics: questionnaire

    Time frame: before and after 12 weeks

    Demographics questionnaire applied during the milk supplementation

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Eduardo Ferriolli

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2016
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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