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) (MIAO50)

January 7, 2014 updated by: Claudio Franceschi, University of Bologna

Nutritional Trial With Fortified Milk in 65+ Years Old Subjects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40126
        • University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

63 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline global health status at 12 weeks of milk intake

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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
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)
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
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)
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
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
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)
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
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.
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)
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
Change from Baseline lymphocyte subsets at 12 weeks of milk intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Claudio Franceschi, MD, University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00088MI01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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