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Trial record 33 of 98 for:    grams | maltodextrin

Improving Rehabilitation In Sarcopenia (IRIS) (IRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03120026
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Mariangela Rondanelli, Azienda di Servizi alla Persona di Pavia

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

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Experimental product Dietary Supplement: Isocaloric placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Gait speed [ Time Frame: 8 weeks ]
    Change in gait speed (4-meter walking test)/month


Secondary Outcome Measures :
  1. Physical performance - Tinetti [ Time Frame: 8 weeks ]
    Change in Tinetti scale

  2. Physical performance - Timed Up and Go test [ Time Frame: 8 weeks ]
    Change in timed up and go test

  3. Physical performance - chair-stand [ Time Frame: 8 weeks ]
    chair-stand test

  4. Functional status - Barthel [ Time Frame: 8 weeks ]
    Change in Barthel index score

  5. Functional status - ADL [ Time Frame: 8 weeks ]
    Change in activities of daily living (ADL) score

  6. Functional status - handgrip strength [ Time Frame: 8 weeks ]
    Change in handgrip strength

  7. Body weight [ Time Frame: 8 weeks ]
    Change in body weight

  8. Muscle mass [ Time Frame: 8 weeks ]
    Change in appendicular muscle mass

  9. Cognitive function - trail making test [ Time Frame: 8 weeks ]
    Change in trail making test

  10. Cognitive function - Mini Mental State Examination [ Time Frame: 8 weeks ]
    Change in Mini Mental State Examination

  11. Quality of life [ Time Frame: 8 weeks ]
    Change in 12-item Short-Form Health Survey score (physical/mental components)

  12. Costs [ Time Frame: 8 weeks ]
    Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures)

  13. Adverse events [ Time Frame: 8 weeks ]
    Difference in rate of adverse events related to gastrointestinal intolerance


Other Outcome Measures:
  1. Intensity of care [ Time Frame: 8 weeks ]
    Reduction in the level of intensity of care on a ordinal scale

  2. Type of discharge [ Time Frame: 8 weeks ]
    Proportion of patients discharged at home



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120026


Locations
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Italy
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
Pavia, Italy, 27100
Sponsors and Collaborators
Azienda di Servizi alla Persona di Pavia
Investigators
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Study Director: Mariangela Rondanelli, MD, PhD Azienda di Servizi alla Persona di Pavia

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Responsible Party: Mariangela Rondanelli, Principal Investigator, Azienda di Servizi alla Persona di Pavia
ClinicalTrials.gov Identifier: NCT03120026     History of Changes
Other Study ID Numbers: 20170011726
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents