Improving Rehabilitation In Sarcopenia (IRIS)

Study Overview
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Brief Summary
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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
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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

Official Title
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A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Sarcopenia in Older Adults Undergoing Physical Rehabilitation the IRIS (Improving Rehabilitation In Sarcopenia) Study: a Randomized, Double-blind, Placebo-controlled Trial.

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Experimental product
* Dietary Supplement: Isocaloric placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Product<br>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 Supplement: Experimental product<br>* 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.<br>|
| Placebo Comparator: Isocaloric Placebo<br>Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water. | Dietary Supplement: Isocaloric placebo<br>* Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed | Change in gait speed (4-meter walking test)/month | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance - Tinetti | Change in Tinetti scale | 8 weeks | 
| Physical performance - Timed Up and Go test | Change in timed up and go test | 8 weeks | 
| Physical performance - chair-stand | chair-stand test | 8 weeks | 
| Functional status - Barthel | Change in Barthel index score | 8 weeks | 
| Functional status - ADL | Change in activities of daily living (ADL) score | 8 weeks | 
| Functional status - handgrip strength | Change in handgrip strength | 8 weeks | 
| Body weight | Change in body weight | 8 weeks | 
| Muscle mass | Change in appendicular muscle mass | 8 weeks | 
| Cognitive function - trail making test | Change in trail making test | 8 weeks | 
| Cognitive function - Mini Mental State Examination | Change in Mini Mental State Examination | 8 weeks | 
| Quality of life | Change in 12-item Short-Form Health Survey score (physical/mental components) | 8 weeks | 
| Costs | Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures) | 8 weeks | 
| Adverse events | Difference in rate of adverse events related to gastrointestinal intolerance | 8 weeks |