Healthy Elder PeopleNCT01985282
Feasibility Clinical Study of NLA Tool
An observational study of Healthy Elder People, run by Société des Produits Nestlé (SPN) at 1 site in Japan.
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 Elder People
- What is being tested?
- Nutrition Status Questionnaires and Physicial Function Test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Jun 2013
- 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: Free-living or institutionalized elderly (65-90years)
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,
Who cannot join
- restricted by a doctor to exercise.
- unable to carry out performance tests and questionnaires correctly,
- lower or upper extremity surgery or fracture in the last 3 months
- having history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment
Trial locations and contacts
1 site in 1 country.
Japan1 site
Graduate School of Comprehensive Human Sciences, Tsukuba University
Tsukuba, Ibaraki
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.
- Conditions
- Healthy Elder People
- Being tested
- Nutrition Status Questionnaires and Physicial Function Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Status Questionnaires and Physicial Function TestBehavioural
Nutrition status questionnaires will be administered, Physical functional status will be tested
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Status and Physical Function | Nutrition questionnaire will be administered Physical functional status will be tested Receives: Behavioral: Nutrition Status Questionnaires and Physicial Function Test |
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 (by statistical approach) who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status
Measured: Day 1 of Study
The Segmentation of Target Population
Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength (By measuring upper and lower extremity strength) and endurance performance (By measuring 6 minutes walking distantce) (33% +/- 10% of target group)
Measured: Day 1 of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elder PeopleStudies of the same condition, open and under way.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kiyoji Tanaka, PhD, Principal investigator, Graduate School of Comprehensive Human Sciences, Tsukuba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985282
- Sponsor's protocol ID
- 12.33.NRC
- Status last verified
- Nov 2013
- First submitted
- 22 Apr 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. 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
- NCT01985282
- Acronym / sponsor ID
- 12.33.NRC
- Conditions
- Healthy Elder People
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Status and Physical Function | – | Behavioral: Nutrition Status Questionnaires and Physicial Function TestNutrition questionnaire will be administered Physical functional status will be tested |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Free-living or institutionalized elderly (65-90years)
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,
Key exclusion criteria (4 listed)
- restricted by a doctor to exercise.
- unable to carry out performance tests and questionnaires correctly,
- lower or upper extremity surgery or fracture in the last 3 months
- having 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Status Questionnaires and Physicial Function TestNutrition status questionnaires will be administered, Physical functional status will be tested | Behavioural | Nutrition Status and Physical Function |
Primary outcome
NLA Feasibility
Time frame: Day 1 of Study
Determining the proportion of elderly subjects (by statistical approach) who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status
The Segmentation of Target Population
Time frame: Day 1 of Study
Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength (By measuring upper and lower extremity strength) and endurance performance (By measuring 6 minutes walking distantce) (33% +/- 10% of target group)
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 15 Nov 2013.
Related trials for Healthy Elder People
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Feru-guard and General Antioxidant Capacity in Older People
Healthy Elder People
Active, not recruiting
CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease)
High Intensity Exercise, Normal Cognition
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.
Kiyoji Tanaka, PhD principal investigator
Graduate School of Comprehensive Human Sciences, Tsukuba 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 Elder People, run by Société des Produits Nestlé (SPN) at 1 site in Japan.
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 4 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 15 Nov 2013. 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 Japan. 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: Day 1 of Study). The study lists 2 primary outcomes in all. 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 15 Nov 2013.