Omics4Aging: Stratification of Frailty Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-15

Study Completion Date

2018-08-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malnutrition Intellectual Frailty of Aging Bone Fragility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No