Improving Rehabilitation In Sarcopenia (IRIS)

Sarcopenia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120026
• Other study ID #: 20170011726
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: December 19, 2018

Study information

• Verified date: January 2019
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Italy	Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia	Pavia
Italy	Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intensity of care	Reduction in the level of intensity of care on a ordinal scale	8 weeks
Other	Type of discharge	Proportion of patients discharged at home	8 weeks
Primary	Gait speed	Change in gait speed (4-meter walking test)/month	8 weeks
Secondary	Physical performance - Tinetti	Change in Tinetti scale	8 weeks
Secondary	Physical performance - Timed Up and Go test	Change in timed up and go test	8 weeks
Secondary	Physical performance - chair-stand	chair-stand test	8 weeks
Secondary	Functional status - Barthel	Change in Barthel index score	8 weeks
Secondary	Functional status - ADL	Change in activities of daily living (ADL) score	8 weeks
Secondary	Functional status - handgrip strength	Change in handgrip strength	8 weeks
Secondary	Body weight	Change in body weight	8 weeks
Secondary	Muscle mass	Change in appendicular muscle mass	8 weeks
Secondary	Cognitive function - trail making test	Change in trail making test	8 weeks
Secondary	Cognitive function - Mini Mental State Examination	Change in Mini Mental State Examination	8 weeks
Secondary	Quality of life	Change in 12-item Short-Form Health Survey score (physical/mental components)	8 weeks
Secondary	Costs	Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures)	8 weeks
Secondary	Adverse events	Difference in rate of adverse events related to gastrointestinal intolerance	8 weeks