Feasibility Clinical Study of NLA Tool-US

Completed

• Conditions: Healthy

• Registration Number: NCT01995682
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

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)

Study Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Study Start: 2013-12
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-06
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NLA feasibility	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

Name	Time	Method
Evaluate the average time required for completing the NLA	One day	Measure the time required to complete the NLA.

Trial Locations

Locations (1)

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University; 🇺🇸 Boston, Massachusetts, United States