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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sarcopenia
- Sponsor
- Azienda di Servizi alla Persona di Pavia
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Gait speed
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Mariangela Rondanelli
Principal Investigator
Azienda di Servizi alla Persona di Pavia
Eligibility Criteria
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
Outcomes
Primary Outcomes
Gait speed
Time Frame: 8 weeks
Change in gait speed (4-meter walking test)/month
Secondary Outcomes
- Functional status - ADL(8 weeks)
- Functional status - handgrip strength(8 weeks)
- Costs(8 weeks)
- Physical performance - Timed Up and Go test(8 weeks)
- Functional status - Barthel(8 weeks)
- Body weight(8 weeks)
- Muscle mass(8 weeks)
- Cognitive function - trail making test(8 weeks)
- Physical performance - Tinetti(8 weeks)
- Physical performance - chair-stand(8 weeks)
- Quality of life(8 weeks)
- Cognitive function - Mini Mental State Examination(8 weeks)
- Adverse events(8 weeks)