Improvement of FunctionalityPhase 3NUDALNCT01539200
Effects of Daily Nutritional Supplementation in Combination With a Eurhythmics Training (NUDAL)
A Phase 3 study testing ONS+JDR and JDR in people with Improvement of Functionality, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Malnutrition and lack of regular exercise are often found in older adults and have been identified as important risk factors for independence loss and nursing home admission in older community-dwelling adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Improvement of Functionality
- What is being tested?
- ONS+JDR and JDR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to Jan 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling males and females, aged ≥ 65 years
- Able to walk unassisted for 15 meters
- MMSE ≥ 24 points
- Having obtained his/her informed consent
Who cannot join
- Serum 25(OH) Vitamin D > 100 nmol/L from the blood sampling at Screening
- Current regular (defined as >3x /week) use of high protein oral nutritional supplements
- Milk protein allergy (Lactose intolerance)
- Severe visual impairment (corrected near vision <0.2 in both eyes)
- Severe neurological, orthopaedic, rheumatologic or psychiatric illness causing inability to understand or follow task instructions or to walk 15 meters without assistance (if clinically questionable, final decision will be made by a senior physician)
- Terminal illness with life expectancy less than 12 months, as determined by a physician
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Basel Mobility Center, Department of Acute Geriatrics
Basel, 4031
About this study
Official title: Effects of 6-months Once Daily Nutritional Supplementation in Combination With a Once Weekly Jacques-Delacroze Eurhythmics Training (NUDAL) on Functionality, Probability of Independence and/or Functional Reserve Among Community-dwelling Seniors
Malnutrition and lack of regular exercise are often found in older adults and have been identified as important risk factors for independence loss and nursing home admission in older community-dwelling adults.
Existing evidence suggests that high protein nutritional supplements can increase skeletal muscle protein synthesis following exercise in older individuals. However, increase of muscle strength by resistance training does not decrease the rate of falls and is not necessarily linked to an improvement of physical function. In contrast to resistance training, T'ai Chi, dance and eurhythmics have been shown to decrease fall incidence and improve mobility and physical function in older adults. The investigators will examine the combination of eurhythmics and high protein nutritional supplements.
The aim of the study is to investigate whether there is an increase in normal walking velocity due to the nutritional supplement on top of once weekly Jacques-Delacroze Eurhythmics training.
- Conditions
- Improvement of Functionality
- Being tested
- ONS+JDR, JDR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONS+JDRDietary supplement
Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training
JDRDietary supplement
Jacques-Delacroze Eurythmic training with placebo ONS
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Dietary Supplement: JDR |
| Oral Nutritional Supplement (ONS) and JDR | Active comparator | Not described Receives: Dietary Supplement: ONS+JDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal walking velocity
The primary objective is to demonstrate in older adults receiving a once weekly Jacques-Delacroze Eurhythmics (JDR) training for six months, that a once daily nutritional supplementation increases normal walking velocity compared with placebo. The primary endpoint of this study is normal walking velocity (NW velocity, in cm/s) six months after the onset of the treatment.
Measured: 6 months
Secondary outcomes (2)
Quality of Life and Nutritional status
The secondary objectives of the research project are to compare the effects of the NUDAL intervention versus JDR alone, on changes in functional measures, nutritional status and health-related quality of life
Measured: baseline, 3 months, 6 months
Normal walking velocity
Normal walking velocity (NW velocity, in cm/s) will also be evaluated three months after the onset of treatment as a secondary outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Improvement of FunctionalityStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reto W Kressig, MD, Principal investigator, Chair of Geriatrics, Medical Faculty, Chief, Department of Acute Geriatrics, University Hospital, Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539200
- Sponsor's protocol ID
- NUD1051
- Acronym
- NUDAL
- Status last verified
- Mar 2014
- First submitted
- 15 Feb 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hardi I, Bridenbaugh SA, Cress ME, Kressig RW. Validity of the German Version of the Continuous-Scale Physical Functional Performance 10 Test. J Aging Res. 2017;2017:9575214. doi: 10.1155/2017/9575214. Epub 2017 Jul 9.
PubMed 28775900
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 6-months Once Daily Nutritional Supplementation in Combination With a Once Weekly Jacques-Delacroze Eurhythmics Training (NUDAL) on Functionality, Probability of Independence and/or Functional Reserve Among Community-dwelling Seniors
- ClinicalTrials.gov ID
- NCT01539200
- Acronym / sponsor ID
- NUDAL / NUD1051
- Conditions
- Improvement of Functionality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Feb 2012 (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.
Malnutrition and lack of regular exercise are often found in older adults and have been identified as important risk factors for independence loss and nursing home admission in older community-dwelling adults.
Existing evidence suggests that high protein nutritional supplements can increase skeletal muscle protein synthesis following exercise in older individuals. However, increase of muscle strength by resistance training does not decrease the rate of falls and is not necessarily linked to an improvement of physical function. In contrast to resistance training, T'ai Chi, dance and eurhythmics have been shown to decrease fall incidence and improve mobility and physical function in older adults. The investigators will examine the combination of eurhythmics and high protein nutritional supplements.
The aim of the study is to investigate whether there is an increase in normal walking velocity due to the nutritional supplement on top of once weekly Jacques-Delacroze Eurhythmics training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: JDR |
| Oral Nutritional Supplement (ONS) and JDR | Active comparator | Dietary Supplement: ONS+JDR |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Community-dwelling males and females, aged ≥ 65 years
- Able to walk unassisted for 15 meters
- MMSE ≥ 24 points
- Having obtained his/her informed consent
Key exclusion criteria (6 listed)
- Serum 25(OH) Vitamin D > 100 nmol/L from the blood sampling at Screening
- Current regular (defined as >3x /week) use of high protein oral nutritional supplements
- Milk protein allergy (Lactose intolerance)
- Severe visual impairment (corrected near vision <0.2 in both eyes)
- Severe neurological, orthopaedic, rheumatologic or psychiatric illness causing inability to understand or follow task instructions or to walk 15 meters without assistance (if clinically questionable, final decision will be made by a senior physician)
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 |
|---|---|---|
| ONS+JDROral Nutritional Supplement with Jacques-Delacroze Eurythmic training | Dietary supplement | Oral Nutritional Supplement (ONS) and JDR |
| JDRJacques-Delacroze Eurythmic training with placebo ONS | Dietary supplement | Control |
Primary outcome
Normal walking velocity
Time frame: 6 months
The primary objective is to demonstrate in older adults receiving a once weekly Jacques-Delacroze Eurhythmics (JDR) training for six months, that a once daily nutritional supplementation increases normal walking velocity compared with placebo. The primary endpoint of this study is normal walking velocity (NW velocity, in cm/s) six months after the onset of the treatment.
2 secondary outcomes
Quality of Life and Nutritional status
Time frame: baseline, 3 months, 6 months
Normal walking velocity
Time frame: 3 months
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 26 Mar 2014.
- Derived from this study: PubMed 28775900Hardi I, Bridenbaugh SA, Cress ME, Kressig RW. Validity of the German Version of the Continuous-Scale Physical Functional Performance 10 Test. J Aging Res. 2017;2017:9575214. doi: 10.1155/2017/9575214. Epub 2017 Jul 9.
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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.
Reto W Kressig, MD principal investigator
Chair of Geriatrics, Medical Faculty, Chief, Department of Acute Geriatrics, University Hospital, Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ONS+JDR and JDR in people with Improvement of Functionality, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 6 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 26 Mar 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Normal walking velocity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01539200, which also lists 1 linked publication.
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 26 Mar 2014.