Clinical trial NCT03120026: Improving Rehabilitation In Sarcopenia (IRIS)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Refusal

Primary outcomes:
measure: Gait speed
timeFrame: 8 weeks
Secondary outcomes:
measure: Physical performance - Tinetti
timeFrame: 8 weeks
measure: Physical performance - Timed Up and Go test
timeFrame: 8 weeks
measure: Physical performance - chair-stand
timeFrame: 8 weeks
measure: Functional status - Barthel
timeFrame: 8 weeks
measure: Functional status - ADL
timeFrame: 8 weeks
measure: Functional status - handgrip strength
timeFrame: 8 weeks
measure: Body weight
timeFrame: 8 weeks
measure: Muscle mass
timeFrame: 8 weeks
measure: Cognitive function - trail making test
timeFrame: 8 weeks
measure: Cognitive function - Mini Mental State Examination
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
measure: Costs
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
Other outcomes:
measure: Intensity of care
timeFrame: 8 weeks
measure: Type of discharge
timeFrame: 8 weeks
Locations:
city: Pavia
country: Italy
facility: Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
city: Pavia
country: Italy
facility: Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia
Study officials:
affiliation: Azienda di Servizi alla Persona di Pavia
name: Mariangela Rondanelli, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Rondanelli M, Cereda E, Klersy C, Faliva MA, Peroni G, Nichetti M, Gasparri C, Iannello G, Spadaccini D, Infantino V, Caccialanza R, Perna S. Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1535-1547. doi: 10.1002/jcsm.12532. Epub 2020 Sep 22.