Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Omics4Aging: Stratification of Frailty Population (ProAge)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572063
Recruitment Status : Terminated (Terminated, prior to its planned completion as anticipated by the protocol.)
First Posted : October 8, 2015
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date May 4, 2015
First Posted Date October 8, 2015
Last Update Posted Date August 16, 2018
Actual Study Start Date November 15, 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2018)
Comparison of Metabonomics, at baseline, among frail population. [ Time Frame: 1 year ]
Analysis of Metabolites in blood
Original Primary Outcome Measures
 (submitted: October 7, 2015)
COMPOSITE MEASURES: Comparison of clinical variables, body composition parameters, lipids/metabolites/nutrients at baseline among healthy, pre-frail, and frail population. [ Time Frame: 1 year ]
Clinical variables:
  • Inflammatory markers (cytokines: IL-1β, IL-4, IL-6, IL-10, IL12 (p70), IL-17A, IL-18, IFN-γ, TNF-α, TGFβ, sIL6R)
  • Standard biochemical measures (hemochrome, Glycated haemoglobin)
  • Plasma levels of: CRP, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, hormones (leptin, adiponectin)
  • Serum levels of: glucose, insulin, parathyroid hormone (PTH), creatinine, HCMV
  • Urine levels of: sodium, nitrogen, potassium, creatinine
  • Blood pressure
Metabonomics:
  • Carnitines,
  • Amino acids,
  • Short-chain fatty acids,
  • Bile acids,
  • Indoles,
  • Ketone bodies,
  • Krebs cycle (metabolites in urine profiling),
  • Bacterial utilization of protein and carbohydrates (metabolites in urine and feces).
Lipidomics: • Quantitation of major lipid classes. Nutrients: • Vitamins, minerals and amino acids, fatty acids.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: October 7, 2015)
  • COMPOSITE MEASURES: Assess the variability of the nutrients and metabolites after one year in relation to disease development, dietary intake. [ Time Frame: 1 year ]
    Correlation of Frailty phenotype with: • Anthropometric measures: height, weight, waist and hip circumference.
  • COMPOSITE MEASURES: Assess the variability of the nutrients and metabolites after one year in relation to disease development, dietary intake [ Time Frame: 1 year ]
    Correlation of Frailty phenotype with: o Body Composition and visceral fat: DXA scan
  • COMPOSITE MEASURES: Assess the variability of the nutrients and metabolites after one year in relation to disease development, dietary intake [ Time Frame: 1 year ]
    Correlation of Frailty phenotype with: o Physical functioning: hand grip strength, ADL, IADL, PASE score and SPPB battery, measure of physical activity by actigraph accelerometer
  • COMPOSITE MEASURES: Assess the variability of the nutrients and metabolites after one year in relation to disease development, dietary intake [ Time Frame: 1 year ]
    Correlation of Frailty phenotype with: o Cognitive status: GDS and CERAD battery
  • COMPOSITE MEASURES: Assess the variability of the nutrients and metabolites after one year in relation to disease development, dietary intake [ Time Frame: 1 year ]
    Correlation of Frailty phenotype with: o Quality of life and risk of malnutrition: SF36 and MNA-SF
  • COMPOSITE MEASURES: Assess the variability of the nutrients and metabolites after one year in relation to disease development, dietary intake [ Time Frame: 1 year ]
    Correlation of Frailty phenotype with: o Insulin sensitivity: Hba1c
  • COMPOSITE MEASURES: Assess the variability of the nutrients and metabolites after one year in relation to disease development, dietary intake [ Time Frame: 1 year ]
    Correlation of Frailty phenotype with: o Cardiovascular health status: lipid profile and blood pressure
  • COMPOSITE MEASURES: Assess the variability of the nutrients and metabolites after one year in relation to disease development, dietary intake [ Time Frame: 1 year ]
    Correlation of Frailty phenotype with: o Dietary intake assessments as per 7 days food record
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Omics4Aging: Stratification of Frailty Population
Official Title Omics4Aging: Stratification of Frailty Population Based on Nutrients Profiling and Metabolic Profiling at Baseline
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and urine samples and feces
Sampling Method Non-Probability Sample
Study Population 50 frail elderly free living healthy individuals, males and females, age 65-79.
Condition
  • Malnutrition
  • Intellectual Frailty of Aging
  • Bone Fragility
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: August 14, 2018)
20
Original Estimated Enrollment
 (submitted: October 7, 2015)
60
Actual Study Completion Date August 14, 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years to 79 Years   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02572063
Other Study ID Numbers 14.02.NIHS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nestlé
Study Sponsor Nestlé
Collaborators Not Provided
Investigators
Principal Investigator: Miriam Capri, PhD University of Bologna
PRS Account Nestlé
Verification Date May 2018