Omics4Aging: Stratification of Frailty Population

Terminated

• Conditions: Malnutrition; Bone Fragility; Intellectual Frailty of Aging

• Registration Number: NCT02572063
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

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 Timeline

• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Study Start: 2015-11-15
• Status Verified: 2018-05
• Primary Completion: 2018-05
• Study Completion: 2018-08-14
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Metabonomics, at baseline, among frail population.	1 year	Analysis of Metabolites in blood

Trial Locations

Locations (1)

Dr. Miriam Capri; 🇮🇹 Bologna, Italy