Nutritional Trial With Fortified Milk in 65+ Years Old Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Global health status
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 63 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
fortified milk
The subjects assumed daily 250 ml of fortified milk for 12 weeks. Then, after a period of wash-out of 12-14 weeks they start to assume placebo milk for 12 weeks.
Intervention: fortified milk (Dietary Supplement)
placebo milk
The subjects assumed daily 250 ml of placebo milk. Then, after a period of wash-out of 12-14 weeks they start to assume fortified milk for 12 weeks.
Intervention: fortified milk (Dietary Supplement)
Outcomes
Primary Outcomes
Global health status
Time Frame: Change from baseline global health status at 12 weeks of milk intake
The health status is evaluated by a tests regarding the cognitive function, the functional status, the perceived health status.
Secondary Outcomes
- Circulating levels of proteins related to inflammatory status such as C reactive protein (CRP); fibrinogen and pro and anti-inflammatory cytokines.(Changes from baseline CRP, fibrinogen, high sensitivity interleukin 6 (hs-IL6) and high sensitivity interleukin 10 (hs-IL10))
- Circulating levels of lipoproteins (Total, HDL and LDL-cholesterol, triglycerides)(change from baseline total, HDL, and LDL-cholesterol and triglycerides at 12 weeks of milk intake)
- Fatty acid composition of red blood cell membranes as an index of cellular homeostasis(Change from Baseline fatty acid composition of red blood cell membranes at 12 weeks of milk intake)
- Blood count and assessment of major lymphocyte sub-populations(Change from Baseline lymphocyte subsets at 12 weeks of milk intake)
- Levels of blood glucose, creatinine, liver transaminases, homocysteine, folic acid(Change from Baseline levels of glucose, creatinine, liver transaminases, homocysteine and folic acid at 12 weeks of milk intake)
- Circulating levels of trace elements such as zinc and selenium(Changes from Baseline levels of zinc and selenium at 12 weeks of milk intake)
- Circulating levels of vitamin D, vitamin E, vitamin B6 and vitamin B12(Change from Baseline levels of vitamin D, vitamin E, vitamin B6 and vitamin B12 at 12 weeks of milk intake)
- Oxidation state of cellular proteins(Change from Baseline oxidation state of cellular proteins at 12 weeks of milk intake)
Investigators
Claudio Franceschi
Professor
University of Bologna