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Clinical Trials/NCT02572063
NCT02572063
Terminated
N/A

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

Société des Produits Nestlé (SPN)1 site in 1 country20 target enrollmentNovember 15, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Société des Produits Nestlé (SPN)
Enrollment
20
Locations
1
Primary Endpoint
Comparison of Metabonomics, at baseline, among frail population.
Status
Terminated
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2015
End Date
August 14, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Société des Produits Nestlé (SPN)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Unless otherwise specified, subjects who fulfill all of the following will be included:
  • Male or female between the ages of 65 and 79 years old
  • Three or more Fried Frailty Criteria (as diagnosed by investigator)
  • Informed consent obtained

Exclusion Criteria

  • Any of the following criteria would render a subject ineligible for inclusion:
  • Dementia (previously diagnosed by general practitioner)
  • Hb1c (glycate Haemoglobin) \>7.5% (\>58 mmol/mol).
  • End stage disease (1 year after last chemotherapy treatment for cancer)
  • Drug abuse (alcohol - assessed by investigator)
  • Medications: no antibiotic treatment (for at least 4 weeks), immune suppressants, and or chronic use of corticosteroids
  • Currently participating or having participated in another clinical or nutritional intervention trial during the last 3 month
  • Chronic active inflammatory disease (e.g. rheumatoid arthritis, vasculitis, lupus erythematosus and Crohn's disease)
  • Chronic Active hepatitis
  • Kidney failure in Dialysis treatment

Outcomes

Primary Outcomes

Comparison of Metabonomics, at baseline, among frail population.

Time Frame: 1 year

Analysis of Metabolites in blood

Study Sites (1)

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