Milk Biofortification Promotes Health Benefits in Institutionalized

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT02980094
Study type	Interventional
Source	University of Sao Paulo
Contact
Status	Completed
Phase	N/A
Start date	August 2011
Completion date	December 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03750968` - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects	Phase 2
Completed	`NCT04669106` - Mineral and Enzyme Deficiency Diseases Associated With Nutritional Diseases in Society
Completed	`NCT03819530` - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study	N/A
Completed	`NCT04223375` - Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota	N/A
Completed	`NCT05166980` - Study of Multiply-fortified Salt Among Women of Reproductive Age and Preschool Children in India	N/A
Not yet recruiting	`NCT04576845` - The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
Completed	`NCT04567823` - Nutrient Bioavailability From Microalgae	N/A
Recruiting	`NCT06156826` - Prenatal Nutrient Status Study
Enrolling by invitation	`NCT05389618` - Dietary Challenges in the Population of Nursing Homes' Residents
Recruiting	`NCT05342766` - Precision Nutrition
Completed	`NCT03061409` - Vitamin and Mineral Supplementation Improves Micronutrient Status in Older Adults	N/A
Completed	`NCT04343508` - Impact of Fortified Rice on Workers' Nutrition Status	N/A
Completed	`NCT03284840` - Adults Nutrition as a Protective or Health-risk Factor
Completed	`NCT03166449` - Effects of Immunonutrition on Biomarkers in Traumatic Brain Injury	N/A
Completed	`NCT04085874` - Effectiveness of Food-Based Recommendations for Minangkabau Women of Reproductive Age With Dyslipidemia	N/A
Completed	`NCT05865015` - Nutritional Status of Women Undergoing in Vitro Fertilization
Recruiting	`NCT04427852` - Nutrition, Vision, and Cognition in Sport Study: Beef	N/A
Recruiting	`NCT04288531` - Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region
Not yet recruiting	`NCT06046703` - Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet
Not yet recruiting	`NCT06168136` - Effects of Medical High Protein Nutrition on the Muscle Mass in Adult ICU Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Milk Biofortification Promotes Health Benefits in Institutionalized Elderly

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms