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Completed

NCT Number: 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)

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.

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Key information

Conditions

Aging

Age range

63 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine

Bologna, 40126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Fortified Milk

Dietary Supplement

"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.

Primary outcomes

  1. 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

  1. Circulating levels of lipoproteins (Total, HDL and LDL-cholesterol, triglycerides)

    Time frame: change from baseline total, HDL, and LDL-cholesterol and triglycerides at 12 weeks of milk intake

    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).

  2. Levels of blood glucose, creatinine, liver transaminases, homocysteine, folic acid

    Time frame: Change from Baseline levels of glucose, creatinine, liver transaminases, homocysteine and folic acid at 12 weeks of milk intake

    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)

  3. Circulating levels of vitamin D, vitamin E, vitamin B6 and vitamin B12

    Time frame: Change from Baseline levels of vitamin D, vitamin E, vitamin B6 and vitamin B12 at 12 weeks of milk intake

    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)

  4. 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

  5. Circulating levels of trace elements such as zinc and selenium

    Time frame: Changes from Baseline levels of zinc and selenium at 12 weeks of milk intake

    Zinc and selenium were measured as microgram/liter (mcg/L)

  6. Oxidation state of cellular proteins

    Time frame: Change from Baseline oxidation state of cellular proteins at 12 weeks of milk intake

  7. Circulating levels of proteins related to inflammatory status such as C reactive protein (CRP); fibrinogen and pro and anti-inflammatory cytokines.

    Time frame: Changes from baseline CRP, fibrinogen, high sensitivity interleukin 6 (hs-IL6) and high sensitivity interleukin 10 (hs-IL10)

    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)

  8. Blood count and assessment of major lymphocyte sub-populations

    Time frame: Change from Baseline lymphocyte subsets at 12 weeks of milk intake

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

Nutritional Trial With Fortified Milk in 65+ Years Old Subjects

Acronym: MIAO50

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2014
Registry last updated
Jan 8, 2014

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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