Omics4Aging: Stratification of Frailty Population (ProAge)
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ClinicalTrials.gov Identifier: NCT02572063
Recruitment Status :
(Terminated, prior to its planned completion as anticipated by the protocol.)
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.
Condition or disease
MalnutritionIntellectual Frailty of AgingBone Fragility
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.
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Layout table for eligibility information
Ages Eligible for Study:
65 Years to 79 Years (Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
50 frail elderly free living healthy individuals, males and females, age 65-79.
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
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