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

Nestlé

Status and phase: Completed; Phase 3

Conditions: Improvement of Functionality

Treatments: Dietary Supplement: JDR; Dietary Supplement: ONS+JDR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01539200

NUD1051

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Treatment:

Dietary Supplement: JDR

Oral Nutritional Supplement (ONS) and JDR

Active Comparator group

Treatment:

Dietary Supplement: ONS+JDR