NCT02572063TerminatedNot Applicable
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 enrollmentStarted: November 15, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Comparison of Metabonomics, at baseline, among frail population.
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to 79 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Any other condition that in the judgment of the lead investigator would not allow the subject to complete the study protocol
Outcomes
Primary Outcomes
Comparison of Metabonomics, at baseline, among frail population.
Time Frame: 1 year
Analysis of Metabolites in blood
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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