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Feasibility Clinical Study of NLA Tool-US (NLA)

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: NCT01995682
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.

Condition or disease
Healthy

Detailed Description:
  • Determining the proportion of elderly subjects who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status;
  • Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength and endurance performance (33% +/- 10% of target group)

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Study Type : Observational
Actual Enrollment : 154 participants
Time Perspective: Cross-Sectional
Official Title: Evaluate the Feasibility of the NLA Tool, a Combined Assessment of Nutritional and Physical Functional Status, to Provide Personalized Advice for the Independence and Mobility of Elderly
Study Start Date : December 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014



Primary Outcome Measures :
  1. NLA feasibility [ Time Frame: One day ]
    Determining the proportion of elderly subjects who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status.


Secondary Outcome Measures :
  1. Evaluate the average time required for completing the NLA [ Time Frame: One day ]
    Measure the time required to complete the NLA.


Biospecimen Retention:   None Retained
No biospecimens are to be collected or retained.


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Independently living men and women at 65-90 years old who are able to walk with or without walking aid
Criteria

Inclusion Criteria:

  1. aged between 65 and 90 years,
  2. able to walk with or without walking aid,
  3. having obtained the subject's written informed consent
  4. free of cognitive impairment (3MSE),

Exclusion Criteria:

  1. self reported restriction to exercise(by a physician or other).
  2. unable to carry out performance tests and questionnaires correctly,
  3. self reported lower or upper extremity surgery or fracture in the last 3 months
  4. self-reported symptomatic coronary artery disease, myocardial infarction in last 6 months
  5. self reported history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment
  6. uncontrolled hypertension (>150/90 mm Hg)
  7. self reported congestive heart failure
  8. unable to communicate in English. Non-English speaking individuals will be excluded due to safety concerns in being able to understand testing instructions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995682


Locations
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United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Roger A Fielding, Ph.D. Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01995682    
Other Study ID Numbers: 12.34.NRC
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014
Keywords provided by Nestlé:
Independent living
walk with or without walking aids