Improving Rehabilitation In Sarcopenia (IRIS) (IRIS)

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.

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

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Experimental product; Dietary supplement: Isocaloric placebo

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia
  • Pavia, Italy, 27100
    • Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 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 supplement: Experimental 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.
Placebo Comparator: Isocaloric Placebo; Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.	Dietary supplement: Isocaloric placebo; Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of care	Reduction in the level of intensity of care on a ordinal scale	8 weeks
Type of discharge	Proportion of patients discharged at home	8 weeks

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia
• Investigators: Study Director: Mariangela Rondanelli, MD, PhD, Azienda di Servizi alla Persona di Pavia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): December 19, 2018
• Study Completion (Actual): December 19, 2018

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 20170011726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No