AgingMIAO50NCT02027285
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)
A study testing fortified milk in people with Aging, run by University of Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 63 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- fortified milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 63 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with an age between 63 and 80 years old, males and females, free-living, resident in Bologna and its province.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine
Bologna, Bologna, 40126
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- fortified milk
- Keywords
- fortified milk, aging, health status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified milkDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: fortified milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global health status
The health status is evaluated by a tests regarding the cognitive function, the functional status, the perceived health status.
Measured: 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)
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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Changes from Baseline levels of zinc and selenium at 12 weeks of milk intake
Oxidation state of cellular proteins
Measured: 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)
Measured: 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
Measured: Change from Baseline lymphocyte subsets at 12 weeks of milk intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Franceschi, University of Bologna
- Investigators
- Claudio Franceschi, MD, Study chair, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027285
- Sponsor's protocol ID
- 00088MI01
- Acronym
- MIAO50
- Status last verified
- Jan 2014
- First submitted
- 17 Dec 2013
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Trial With Fortified Milk in 65+ Years Old Subjects
- ClinicalTrials.gov ID
- NCT02027285
- Acronym / sponsor ID
- MIAO50 / 00088MI01
- Conditions
- Aging
- Keywords
- fortified milk, aging, health status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fortified milk | Experimental | Dietary Supplement: fortified milkThe 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. |
| placebo milk | Placebo comparator | Dietary Supplement: fortified milkThe 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. |
Who may qualify
- Ages
- 63 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with an age between 63 and 80 years old, males and females, free-living, resident in Bologna and its province.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | fortified milk, placebo milk |
Primary outcome
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.
8 secondary outcomes
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
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
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
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Franceschi, MD study chair
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fortified milk in people with Aging, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global health status (time frame: Change from baseline global health status at 12 weeks of milk intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.