Omics4Aging: Stratification of Frailty Population

Omics4Aging: Stratification of Frailty Population Based on Nutrients Profiling and Metabolic Profiling at Baseline

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02572063

Acronym

ProAge

Enrollment

Registered

2015-10-08

Start date

2015-11-15

Completion date

2018-08-14

Last updated

2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Fragility, Intellectual Frailty of Aging, Malnutrition

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Italy

Outcome results