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

This study is currently recruiting participants.
Verified April 2012 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01539200
First received: February 15, 2012
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Improvement of Functionality
 Dietary Supplement: ONS+JDR
Dietary Supplement: JDR
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Normal walking velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of Life and Nutritional status [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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

  • Normal walking velocity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Normal walking velocity (NW velocity, in cm/s) will also be evaluated three months after the onset of treatment as a secondary outcome


Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Dietary Supplement: JDR
Jacques-Delacroze Eurythmic training with placebo ONS
Active Comparator: Oral Nutritional Supplement (ONS) and JDR Dietary Supplement: ONS+JDR
Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539200

Contacts
Contact: Stephanie A Bridenbaugh, MD +41 61 328 68 82 bridenbaughs@uhbs.ch

Locations
Switzerland
Basel Mobility Center, Department of Acute Geriatrics Recruiting
Basel, Switzerland, 4031
Contact: Stephanie A Bridenbaugh, MD     +4161 328 6882     bridenbaughs@uhbs.ch    
Principal Investigator: Reto W Kressig, MD            
Sub-Investigator: Stephanie A Bridenbaugh, MD            
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Reto W Kressig, MD Chair of Geriatrics, Medical Faculty, Chief, Department of Acute Geriatrics, University Hospital, Basel
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01539200     History of Changes
Other Study ID Numbers: NUD1051
Study First Received: February 15, 2012
Last Updated: April 20, 2012
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on June 18, 2013