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Effects of Daily Nutritional Supplementation in Combination With a Eurhythmics Training (NUDAL)

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01539200
Acronym
NUDAL
Enrollment
80
Registered
2012-02-27
Start date
2012-03-31
Completion date
2014-01-31
Last updated
2014-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improvement of Functionality

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTONS+JDR

Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training

DIETARY_SUPPLEMENTJDR

Jacques-Delacroze Eurythmic training with placebo ONS

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Community-dwelling males and females, aged ≥ 65 years * Able to walk unassisted for 15 meters * MMSE ≥ 24 points * Having obtained his/her informed consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Normal walking velocity6 monthsThe 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.

Secondary

MeasureTime frameDescription
Quality of Life and Nutritional statusbaseline, 3 months, 6 monthsThe 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
Normal walking velocity3 monthsNormal walking velocity (NW velocity, in cm/s) will also be evaluated three months after the onset of treatment as a secondary outcome

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026