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

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 Overview

• Status: Completed
• Conditions: Improvement of Functionality
• Intervention / Treatment: Dietary supplement: JDR; Dietary supplement: ONS+JDR

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Basel Mobility Center, Department of Acute Geriatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 months

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Reto W Kressig, MD, Chair of Geriatrics, Medical Faculty, Chief, Department of Acute Geriatrics, University Hospital, Basel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: February 21, 2012
• First Posted (Estimate): February 27, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: NUD1051