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

Phase 3

Completed

• Conditions: Improvement of Functionality
• Interventions: Dietary Supplement: JDR; Dietary Supplement: ONS+JDR

• Registration Number: NCT01539200
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-27
• Study Start: 2012-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-25
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	JDR	-
Oral Nutritional Supplement (ONS) and JDR	ONS+JDR	-

Primary Outcome Measures

Name	Time	Method
Normal walking velocity	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

Name	Time	Method
Quality of Life and Nutritional status	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
Normal walking velocity	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

Trial Locations

Locations (1)

Basel Mobility Center, Department of Acute Geriatrics; 🇨🇭 Basel, Switzerland