HealthyNLANCT01995682
Feasibility Clinical Study of NLA Tool-US
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Independently living men and women at 65-90 years old who are able to walk with or without walking aid
Who may be able to join
- aged between 65 and 90 years,
- able to walk with or without walking aid,
- having obtained the subject's written informed consent
- free of cognitive impairment (3MSE),
Who cannot join
- self reported restriction to exercise(by a physician or other).
- unable to carry out performance tests and questionnaires correctly,
- self reported lower or upper extremity surgery or fracture in the last 3 months
- self-reported symptomatic coronary artery disease, myocardial infarction in last 6 months
- self reported history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment
- uncontrolled hypertension (>150/90 mm Hg)
- self reported congestive heart failure
- unable to communicate in English. Non-English speaking individuals will be excluded due to safety concerns in being able to understand testing instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, 02111
About this study
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
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.
Read the 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)
- Conditions
- Healthy
- Keywords
- Independent living, walk with or without walking aids
What is being measured
The primary outcome is the main question the study is designed to answer.
NLA feasibility
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.
Measured: One day
Secondary outcomes (1)
Evaluate the average time required for completing the NLA
Measure the time required to complete the NLA.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger A Fielding, Ph.D., Principal investigator, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995682
- Sponsor's protocol ID
- 12.34.NRC
- Acronym
- NLA
- Status last verified
- Aug 2014
- First submitted
- 21 Nov 2013
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01995682
- Acronym / sponsor ID
- NLA / 12.34.NRC
- Conditions
- Healthy
- Keywords
- Independent living, walk with or without walking aids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Independently living men and women at 65-90 years old who are able to walk with or without walking aid
Key inclusion criteria (4 listed)
- aged between 65 and 90 years,
- able to walk with or without walking aid,
- having obtained the subject's written informed consent
- free of cognitive impairment (3MSE),
Key exclusion criteria (8 listed)
- self reported restriction to exercise(by a physician or other).
- unable to carry out performance tests and questionnaires correctly,
- self reported lower or upper extremity surgery or fracture in the last 3 months
- self-reported symptomatic coronary artery disease, myocardial infarction in last 6 months
- self reported history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Evaluate the average time required for completing the NLA
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger A Fielding, Ph.D. principal investigator
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NLA feasibility (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.