MalnutritionProAgeNCT02572063
Omics4Aging: Stratification of Frailty Population
An observational study of Malnutrition and Intellectual Frailty of Aging, run by Société des Produits Nestlé (SPN) at 1 site in Italy.
Trial summary
The overall objective of the study is to stratify a frailty population based on nutrients profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low molecular weight metabolites in urine and plasma) at baseline. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Malnutrition, Intellectual Frailty of Aging, Bone Fragility
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2015to 14 Aug 2018
- Phase
- Observational
- 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 65 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Study population: 50 frail elderly free living healthy individuals, males and females, age 65-79.
Who may be able to join
- Unless otherwise specified, subjects who fulfill all of the following will be included:
- Caucasian
- Male or female between the ages of 65 and 79 years old
- Three or more Fried Frailty Criteria (as diagnosed by investigator)
- Informed consent obtained
Who cannot join
- Any of the following criteria would render a subject ineligible for inclusion:
- Dementia (previously diagnosed by general practitioner)
- Hb1c (glycate Haemoglobin) >7.5% (>58 mmol/mol).
- End stage disease (1 year after last chemotherapy treatment for cancer)
- Drug abuse (alcohol - assessed by investigator)
- Medications: no antibiotic treatment (for at least 4 weeks), immune suppressants, and or chronic use of corticosteroids
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- Currently participating or having participated in another clinical or nutritional intervention trial during the last 3 month
- Chronic active inflammatory disease (e.g. rheumatoid arthritis, vasculitis, lupus erythematosus and Crohn's disease)
- Chronic Active hepatitis
- Kidney failure in Dialysis treatment
- Any other condition that in the judgment of the lead investigator would not allow the subject to complete the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omics4Aging: Stratification of Frailty Population Based on Nutrients Profiling and Metabolic Profiling at Baseline
The overall objective of the study is to stratify a frailty population based on nutrients profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low molecular weight metabolites in urine and plasma) at baseline.
Read the detailed description
This exploratory study will investigate ways to better characterize the frailty phenotype by a combination of i) geriatric assessment (here only: frailty criteria according to Fried), ii) clinical surrogate markers (including those of inflammation), iii) body composition, iv) nutritional profiling, v) metabolite profiling using a metabolomics approaches.
- Conditions
- Malnutrition, Intellectual Frailty of Aging, Bone Fragility
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Metabonomics, at baseline, among frail population.
Analysis of Metabolites in blood
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start15 Nov 2015
- Primary completionMay 2018
- Study completion14 Aug 2018
Why it stopped: Terminated, prior to its planned completion as anticipated by the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miriam Capri, PhD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572063
- Sponsor's protocol ID
- 14.02.NIHS
- Acronym
- ProAge
- Status last verified
- May 2018
- First submitted
- 4 May 2015
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omics4Aging: Stratification of Frailty Population Based on Nutrients Profiling and Metabolic Profiling at Baseline
- ClinicalTrials.gov ID
- NCT02572063
- Acronym / sponsor ID
- ProAge / 14.02.NIHS
- Conditions
- Malnutrition, Intellectual Frailty of Aging, Bone Fragility
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated, prior to its planned completion as anticipated by the protocol.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 8 Oct 2015 (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 overall objective of the study is to stratify a frailty population based on nutrients profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low molecular weight metabolites in urine and plasma) at baseline.
Detailed description
This exploratory study will investigate ways to better characterize the frailty phenotype by a combination of i) geriatric assessment (here only: frailty criteria according to Fried), ii) clinical surrogate markers (including those of inflammation), iii) body composition, iv) nutritional profiling, v) metabolite profiling using a metabolomics approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 50 frail elderly free living healthy individuals, males and females, age 65-79.
Key inclusion criteria (5 listed)
- Caucasian
- Male or female between the ages of 65 and 79 years old
- Three or more Fried Frailty Criteria (as diagnosed by investigator)
- Informed consent obtained
Key exclusion criteria (11 listed)
- Dementia (previously diagnosed by general practitioner)
- Hb1c (glycate Haemoglobin) >7.5% (>58 mmol/mol).
- End stage disease (1 year after last chemotherapy treatment for cancer)
- Drug abuse (alcohol - assessed by investigator)
- Medications: no antibiotic treatment (for at least 4 weeks), immune suppressants, and or chronic use of corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Metabonomics, at baseline, among frail population.
Time frame: 1 year
Analysis of Metabolites in blood
Results and safety
The study was stopped early (reason given: Terminated, prior to its planned completion as anticipated by the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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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.
Miriam Capri, PhD principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Intellectual Frailty of Aging, run by Société des Produits Nestlé (SPN) 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 Aug 2018. 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. 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 was stopped early (reason given: Terminated, prior to its planned completion as anticipated by the protocol.). Results are not available in the source record.
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?
Comparison of Metabonomics, at baseline, among frail population. (time frame: 1 year). 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 16 Aug 2018.