Sarcopenia
Conditions
Brief summary
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
Detailed description
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
Interventions
DIETARY_SUPPLEMENTExperimental product
Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
DIETARY_SUPPLEMENTIsocaloric placebo
Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 65 years or older * admission for physical rehabilitation * sarcopenia, measured with bioelectrical impedance assessment (BIA) + handgrip strength and gait speed * Mini Mental State Examination ≥18 * Informed consent
Exclusion criteria
* Any malignant disease during the last five years * Known kidney failure (previous glomerular filtration rate \<30 ml/min); * Known liver failure (Child B or C) * Psychiatric disease * Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis) * Indications related to the study product: More than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study. * Known allergy to milk, milk products or other components of the proposed interventions * Indication to or ongoing artificial nutrition support * Inclusion in other nutrition intervention trials * Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * Refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait speed | 8 weeks | Change in gait speed (4-meter walking test)/month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance - Tinetti | 8 weeks | Change in Tinetti scale |
| Physical performance - Timed Up and Go test | 8 weeks | Change in timed up and go test |
| Physical performance - chair-stand | 8 weeks | chair-stand test |
| Functional status - Barthel | 8 weeks | Change in Barthel index score |
| Functional status - ADL | 8 weeks | Change in activities of daily living (ADL) score |
| Functional status - handgrip strength | 8 weeks | Change in handgrip strength |
| Body weight | 8 weeks | Change in body weight |
| Costs | 8 weeks | Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures) |
| Adverse events | 8 weeks | Difference in rate of adverse events related to gastrointestinal intolerance |
| Muscle mass | 8 weeks | Change in appendicular muscle mass |
| Cognitive function - trail making test | 8 weeks | Change in trail making test |
| Cognitive function - Mini Mental State Examination | 8 weeks | Change in Mini Mental State Examination |
| Quality of life | 8 weeks | Change in 12-item Short-Form Health Survey score (physical/mental components) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intensity of care | 8 weeks | Reduction in the level of intensity of care on a ordinal scale |
| Type of discharge | 8 weeks | Proportion of patients discharged at home |
Countries
Italy
Outcome results
None listed