Omics4Aging: Stratification of Frailty Population (ProAge)

August 14, 2018 updated by: Nestlé

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

20

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
        • Dr. Miriam Capri

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

Ages Eligible for Study

65 years to 79 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 frail elderly free living healthy individuals, males and females, age 65-79.

Description

Inclusion Criteria:

Unless otherwise specified, subjects who fulfill all of the following will be included:

  1. Caucasian
  2. Male or female between the ages of 65 and 79 years old
  3. Three or more Fried Frailty Criteria (as diagnosed by investigator)
  4. Informed consent obtained

Exclusion Criteria:

Any of the following criteria would render a subject ineligible for inclusion:

  1. Dementia (previously diagnosed by general practitioner)
  2. Hb1c (glycate Haemoglobin) >7.5% (>58 mmol/mol).
  3. End stage disease (1 year after last chemotherapy treatment for cancer)
  4. Drug abuse (alcohol - assessed by investigator)
  5. Medications: no antibiotic treatment (for at least 4 weeks), immune suppressants, and or chronic use of corticosteroids
  6. Currently participating or having participated in another clinical or nutritional intervention trial during the last 3 month
  7. Chronic active inflammatory disease (e.g. rheumatoid arthritis, vasculitis, lupus erythematosus and Crohn's disease)
  8. Chronic Active hepatitis
  9. Kidney failure in Dialysis treatment
  10. Any other condition that in the judgment of the lead investigator would not allow the subject to complete the study protocol

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Metabonomics, at baseline, among frail population.
Time Frame: 1 year
Analysis of Metabolites in blood
1 year

Collaborators and Investigators

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

Sponsor

Nestlé

Investigators

  • Principal Investigator: Miriam Capri, PhD, 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 (Actual)

November 15, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

August 14, 2018

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.02.NIHS

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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