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Omics4Aging: Stratification of Frailty Population (ProAge)

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ClinicalTrials.gov Identifier: NCT02572063
Recruitment Status : Terminated (Terminated, prior to its planned completion as anticipated by the protocol.)
First Posted : October 8, 2015
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief 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.

Condition or disease
Malnutrition Intellectual Frailty of Aging Bone Fragility

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Omics4Aging: Stratification of Frailty Population Based on Nutrients Profiling and Metabolic Profiling at Baseline
Actual Study Start Date : November 15, 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : August 14, 2018



Primary Outcome Measures :
  1. Comparison of Metabonomics, at baseline, among frail population. [ Time Frame: 1 year ]
    Analysis of Metabolites in blood


Biospecimen Retention:   Samples With DNA
Blood and urine samples and feces


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 frail elderly free living healthy individuals, males and females, age 65-79.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572063


Locations
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Italy
Dr. Miriam Capri
Bologna, Italy, 40126
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Miriam Capri, PhD University of Bologna
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02572063    
Other Study ID Numbers: 14.02.NIHS
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Malnutrition
Frailty
Nutrition Disorders
Pathologic Processes