An interventional study of fortified milk in Aging, sponsored by University of Bologna. Completed at 1 site in Italy. Open to participants aged 63 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-08.
Sponsored by University of Bologna · Not applicable, Interventional, and Basic science
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.
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.
University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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.
Dietary Supplement: fortified 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.
Dietary Supplement: fortified milk
"Fortified"Ultra-high temperature (UHT), partly-skimmed milk (1.6% fat), highly digestible (lactose \<0.5%) produced by Granarolo s.p.a. supplemented with long chain unsaturated fatty acids DHA (Docosahexaenoic acid) +EPA (Eicosapentaenoic acid), vitamin D, B12, B6, B9, E,C, Zinc and Selenium versus "placebo" Ultra-high temperature (UHT), partly-skimmed milk (1.6% fat), highly digestible (lactose \<0.5%) of the same manufacturer. The nutrients added are: DHA + EPA 1.4 mg/ml; vitamin D3 0.068 mcg/ml; B6 6.4 mcg/ml; B12 0.01 mcg/ml; B9 (folic acid) 0.80 mcg/ml; vitamin E 0.05 mg/ml; vitamin C 0.19 mg/ml; Zinc 0.04 mg/ml; Selenium 0.22 mcg/ml. The protein content of the milk is 0.04 g/ml.
Global health status
The health status is evaluated by a tests regarding the cognitive function, the functional status, the perceived health status.
Time frame: Change from baseline global health status at 12 weeks of milk intake
Circulating levels of lipoproteins (Total, HDL and LDL-cholesterol, triglycerides)
total cholesterol is measured as milligram/100milliliters (mg/100ml); HDL-cholesterol as milligram/100milliliters (mg/100ml); LDL-cholesterol as milligram/100milliliters (mg/100ml); triglycerides as milligram/100milliliters (mg/100ml).
Time frame: change from baseline total, HDL, and LDL-cholesterol and triglycerides at 12 weeks of milk intake
Levels of blood glucose, creatinine, liver transaminases, homocysteine, folic acid
Glucose was measured as milligram/deciliter (mg/dl); creatinine as milligram/deciliter (mg/dl), liver transaminases as International units/liter (U/L); homocysteine as micromoles/L and folic acid as nanogram/milliliter (ng/ml)
Time frame: Change from Baseline levels of glucose, creatinine, liver transaminases, homocysteine and folic acid at 12 weeks of milk intake
Circulating levels of vitamin D, vitamin E, vitamin B6 and vitamin B12
Vitamin D was measured as nanogram/milliliters (ng/ml); vitamin E as micrograms/milliliters (mcg/ml); vitamin B6 as micrograms/liter (mcg/L) and vitamin B12 as picograms/milliliters (pg/ml)
Time frame: Change from Baseline levels of vitamin D, vitamin E, vitamin B6 and vitamin B12 at 12 weeks of milk intake
Fatty acid composition of red blood cell membranes as an index of cellular homeostasis
Time frame: Change from Baseline fatty acid composition of red blood cell membranes at 12 weeks of milk intake
Circulating levels of trace elements such as zinc and selenium
Zinc and selenium were measured as microgram/liter (mcg/L)
Time frame: Changes from Baseline levels of zinc and selenium at 12 weeks of milk intake
Oxidation state of cellular proteins
Time frame: Change from Baseline oxidation state of cellular proteins at 12 weeks of milk intake
Circulating levels of proteins related to inflammatory status such as C reactive protein (CRP); fibrinogen and pro and anti-inflammatory cytokines.
C reactive protein was measured as milligram/liter (mg/l); fibrinogen as milligram/deciliter (mg/dl); hs-IL6 and hs-IL10 as picograms/milliliter (pg/ml)
Time frame: Changes from baseline CRP, fibrinogen, high sensitivity interleukin 6 (hs-IL6) and high sensitivity interleukin 10 (hs-IL10)
Blood count and assessment of major lymphocyte sub-populations
Time frame: Change from Baseline lymphocyte subsets at 12 weeks of milk intake
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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University of Bologna