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Improving Rehabilitation In Sarcopenia (IRIS) (IRIS)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Experimental product
Isocaloric placebo
Sponsored by
Azienda di Servizi alla Persona di Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Product

Isocaloric Placebo

Arm Description

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.

Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.

Outcomes

Primary Outcome Measures

Gait speed
Change in gait speed (4-meter walking test)/month

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2017
Last Updated
January 30, 2019
Sponsor
Azienda di Servizi alla Persona di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT03120026
Brief Title
Improving Rehabilitation In Sarcopenia (IRIS)
Acronym
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Product
Arm Type
Experimental
Arm Description
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.
Arm Title
Isocaloric Placebo
Arm Type
Placebo Comparator
Arm Description
Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental product
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Isocaloric placebo
Intervention Description
Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.
Primary Outcome Measure Information:
Title
Gait speed
Description
Change in gait speed (4-meter walking test)/month
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Physical performance - Tinetti
Description
Change in Tinetti scale
Time Frame
8 weeks
Title
Physical performance - Timed Up and Go test
Description
Change in timed up and go test
Time Frame
8 weeks
Title
Physical performance - chair-stand
Description
chair-stand test
Time Frame
8 weeks
Title
Functional status - Barthel
Description
Change in Barthel index score
Time Frame
8 weeks
Title
Functional status - ADL
Description
Change in activities of daily living (ADL) score
Time Frame
8 weeks
Title
Functional status - handgrip strength
Description
Change in handgrip strength
Time Frame
8 weeks
Title
Body weight
Description
Change in body weight
Time Frame
8 weeks
Title
Muscle mass
Description
Change in appendicular muscle mass
Time Frame
8 weeks
Title
Cognitive function - trail making test
Description
Change in trail making test
Time Frame
8 weeks
Title
Cognitive function - Mini Mental State Examination
Description
Change in Mini Mental State Examination
Time Frame
8 weeks
Title
Quality of life
Description
Change in 12-item Short-Form Health Survey score (physical/mental components)
Time Frame
8 weeks
Title
Costs
Description
Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures)
Time Frame
8 weeks
Title
Adverse events
Description
Difference in rate of adverse events related to gastrointestinal intolerance
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Intensity of care
Description
Reduction in the level of intensity of care on a ordinal scale
Time Frame
8 weeks
Title
Type of discharge
Description
Proportion of patients discharged at home
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli, MD, PhD
Organizational Affiliation
Azienda di Servizi alla Persona di Pavia
Official's Role
Study Director
Facility Information:
Facility Name
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32961041
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.
Results Reference
derived

Learn more about this trial

Improving Rehabilitation In Sarcopenia (IRIS)

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