Omics4Aging: Stratification of Frailty Population

Malnutrition Clinical Trial

— ProAge  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02572063
• Other study ID #: 14.02.NIHS
• Status: Terminated
• Start date: November 15, 2015
• Est. completion date: August 14, 2018

Study information

• Verified date: May 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 14, 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Fragility
• Intellectual Frailty of Aging
• Malnutrition

Locations

Country	Name	City	State
Italy	Dr. Miriam Capri	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Italy, 

Outcome

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