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)

NCT02027285 | Completed

• 1 other identifier: 00088MI01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

fortified milk, aging, health status

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

• 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 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

• 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

• Circulating levels of trace elements such as zinc and selenium

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

Study Arms (2)

fortified milk

EXPERIMENTAL

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

placebo milk

PLACEBO COMPARATOR

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

Interventions

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.

fortified milk; placebo milk

Eligibility Criteria

• Age: 63 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

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

Bologna, Bologna, 40126, Italy

Location

Study Officials

• Claudio Franceschi, MD

  University of Bologna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: January 6, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

IT (1)