Clinical trial NCT02027285: Nutrition, Health and Quality of Life: Development of New Formulations of Traditional Products of the "Made in Italy" Diet Optimized for Consumers With an Age Over 50 Years (MIAO 50)
Official title: Nutritional Trial With Fortified Milk in 65+ Years Old Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: fortified milk, aging, health status
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 48
Sex: ALL
Minimum age (years): 63
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study ""Nutritional trial with fortified milk in 65+ years old subjects" is a part of a complex research project and multi-sectoral development (MIAO 50) with the participation of University Research Institutes and small and medium Italian enterprises.

The general objective of the call is to promote the collaboration between the best scientific knowledge, both epidemiological and experimental, and the most advanced technologies to develop foods with a nutritional profile adequate to the needs of consumers with an age over 50 years old, which are easy to use and make it possible to eat in a healthy manner, complete and balanced and also meets the quality and flavors of traditional Italian.

Detailed description: Aging is associated with a functional decline of most physiological systems including the immune system. It could be hypothesized that an inadequate nutritional status may amplify the effects of a low-grade chronic inflammation associated with age influencing the functionality of the immune systems, the resistance to infections, the cognitive function and contributing to an increased morbidity and mortality. Indeed experimental evidence indicate that improving the nutritional status attenuates the decline in immune and cognitive functions, in physical performance associated with age by helping to improve the level of Quality of Life.

Therefore, the present study focus on nutrients and micronutrient which have a role in fighting oxidative stress, in the regulation of inflammatory responses and the immune system.

Eligibility criteria: Inclusion Criteria:

* Subjects with an age between 63 and 80 years old, males and females, free-living, resident in Bologna and its province.

Exclusion Criteria:

* Allergy or intolerance to cow's milk or a dislike. Dietary treatments and use of specific supplements of molecules associated with the proposed intervention up to two months before the start of the trial. Presence of celiac disease and other malabsorption. Presence of disease with poor prognosis in the short term. Chronic therapy with anticoagulants, corticosteroids, and anti-cancer. Exclusion of subjects with onset of chronic-degenerative diseases in the last year, presence of type I diabetes and chronic viral hepatitis.

Primary outcomes:
measure: Global health status
timeFrame: Change from baseline global health status at 12 weeks of milk intake
Secondary outcomes:
measure: Circulating levels of lipoproteins (Total, HDL and LDL-cholesterol, triglycerides)
timeFrame: change from baseline total, HDL, and LDL-cholesterol and triglycerides at 12 weeks of milk intake
measure: Levels of blood glucose, creatinine, liver transaminases, homocysteine, folic acid
timeFrame: Change from Baseline levels of glucose, creatinine, liver transaminases, homocysteine and folic acid at 12 weeks of milk intake
measure: Circulating levels of vitamin D, vitamin E, vitamin B6 and vitamin B12
timeFrame: Change from Baseline levels of vitamin D, vitamin E, vitamin B6 and vitamin B12 at 12 weeks of milk intake
measure: Fatty acid composition of red blood cell membranes as an index of cellular homeostasis
timeFrame: Change from Baseline fatty acid composition of red blood cell membranes at 12 weeks of milk intake
measure: Circulating levels of trace elements such as zinc and selenium
timeFrame: Changes from Baseline levels of zinc and selenium at 12 weeks of milk intake
measure: Oxidation state of cellular proteins
timeFrame: Change from Baseline oxidation state of cellular proteins at 12 weeks of milk intake
measure: Circulating levels of proteins related to inflammatory status such as C reactive protein (CRP); fibrinogen and pro and anti-inflammatory cytokines.
timeFrame: Changes from baseline CRP, fibrinogen, high sensitivity interleukin 6 (hs-IL6) and high sensitivity interleukin 10 (hs-IL10)
measure: Blood count and assessment of major lymphocyte sub-populations
timeFrame: Change from Baseline lymphocyte subsets at 12 weeks of milk intake
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine
Study officials:
affiliation: University of Bologna
name: Claudio Franceschi, MD
role: STUDY_CHAIR
References: