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)

Aging Clinical Trial

— MIAO50  

Official title:

Nutritional Trial With Fortified Milk in 65+ Years Old Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027285
• Other study ID #: 00088MI01
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: January 7, 2014
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 63 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global health status	The health status is evaluated by a tests regarding the cognitive function, the functional status, the perceived health status.	Change from baseline global health status at 12 weeks of milk intake	No
Secondary	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).	change from baseline total, HDL, and LDL-cholesterol and triglycerides at 12 weeks of milk intake	No
Secondary	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)	Change from Baseline levels of glucose, creatinine, liver transaminases, homocysteine and folic acid at 12 weeks of milk intake	No
Secondary	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)	Change from Baseline levels of vitamin D, vitamin E, vitamin B6 and vitamin B12 at 12 weeks of milk intake	No
Secondary	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	No
Secondary	Circulating levels of trace elements such as zinc and selenium	Zinc and selenium were measured as microgram/liter (mcg/L)	Changes from Baseline levels of zinc and selenium at 12 weeks of milk intake	No
Secondary	Oxidation state of cellular proteins		Change from Baseline oxidation state of cellular proteins at 12 weeks of milk intake	No
Secondary	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)	Changes from baseline CRP, fibrinogen, high sensitivity interleukin 6 (hs-IL6) and high sensitivity interleukin 10 (hs-IL10)	No
Secondary	Blood count and assessment of major lymphocyte sub-populations		Change from Baseline lymphocyte subsets at 12 weeks of milk intake	No