NCT02572063

Terminated

Omics4Aging: Stratification of Frailty Population

Société des Produits Nestlé (SPN)Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

14.02.NIHS

Study Type

observational

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

November 15, 2015

Actual (reported)

Primary Completion

May 2018

Actual (reported)

Study Completion

August 14, 2018

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 20 participants
Study completion date: August 14, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 4, 2015
Actual (reported)
First Posted
October 8, 2015
Actual (reported)
Study Start
November 15, 2015
Actual (reported)
Primary Completion
May 2018
Actual (reported)
Study Completion
August 14, 2018
Actual (reported)

Last Updated: August 16, 2018
Status Verified: May 2018
Last Update Submitted: August 14, 2018

Conditions

Bone Fragility Intellectual Frailty of Aging Malnutrition

Outcome Measures

Primary Outcomes (1)

Comparison of Metabonomics, at baseline, among frail population.
Analysis of Metabolites in blood
1 year

Eligibility Criteria

Age65 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

50 frail elderly free living healthy individuals, males and females, age 65-79.

You may qualify if:

Unless otherwise specified, subjects who fulfill all of the following will be included:

Sponsors & Collaborators

Société des Produits Nestlé (SPN)
Industrylead

Study Sites (1)

Dr. Miriam Capri

Bologna, 40126, Italy

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples and feces

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

Miriam Capri, PhD
University of Bologna
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

October 8, 2015

Study Start

November 15, 2015

Actual (reported)

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Caucasian

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

May 2018

Actual (reported)

Study Completion

August 14, 2018

Actual (reported)

Last Updated

August 16, 2018

Record last verified: 2018-05

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT02572063
Data provider: ClinicalTrials.gov
Source updated: 2018-08-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:00 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations