Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 1 for:    NUDAL
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01539200
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Improvement of Functionality Dietary Supplement: ONS+JDR Dietary Supplement: JDR Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Quality of Life and Nutritional status [ Time Frame: baseline, 3 months, 6 months ]
    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

  2. Normal walking velocity [ Time Frame: 3 months ]
    Normal walking velocity (NW velocity, in cm/s) will also be evaluated three months after the onset of treatment as a secondary outcome

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01539200

Layout table for location information
Basel Mobility Center, Department of Acute Geriatrics
Basel, Switzerland, 4031
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Reto W Kressig, MD Chair of Geriatrics, Medical Faculty, Chief, Department of Acute Geriatrics, University Hospital, Basel
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nestlé Identifier: NCT01539200    
Other Study ID Numbers: NUD1051
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014