Improving Rehabilitation In Sarcopenia (IRIS)

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: Isocaloric placebo; Dietary Supplement: Experimental product

Study type: Interventional

Funder types: Other

Identifiers

NCT03120026

20170011726

Details and patient eligibility

About

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

Full 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

Enrollment: 140 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Experimental Product

Experimental group

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.

Treatment:

Dietary Supplement: Experimental product

Isocaloric Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Isocaloric placebo