NCT02572063

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
Last Updated

August 16, 2018

Status Verified

May 1, 2018

Enrollment Period

2.5 years

First QC Date

May 4, 2015

Last Update Submit

August 14, 2018

Conditions

MalnutritionIntellectual Frailty of AgingBone Fragility

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:
  • 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.

Sponsors & Collaborators

Study Sites (1)

Dr. Miriam Capri

Bologna, 40126, Italy

Location

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

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

Primary Completion

May 1, 2018

Study Completion

August 14, 2018

Last Updated

August 16, 2018

Record last verified: 2018-05

Locations

IT(1)