Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

March 25, 2015 updated by: Azienda di Servizi alla Persona di Pavia

Whey Protein, Amino Acids and Vitamin D Supplementation With Physical Activity Increases Muscle Mass and Strength, Functionality and Quality of Life and Decreases Inflammation in Sarcopenic Elderly

This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids and vitamin D concurrent with regular, controlled physical activity would increase muscle mass, strength, physical functional, quality of life, and decrease the risk of malnutrition and inflammation in sarcopenic elderly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation (32 g) with whey protein, essential amino acids and vitamin D concurrent with regular, controlled physical activity would increase muscle mass (assessed by DXA), strength (assessed by handgrip dynamometer), physical functional (assessed by ADL), quality of life (assessed by SF-36), and decrease the risk of malnutrition (assessed by MNA and IGF-I) and inflammation (assessed by C-reactive protein) in sarcopenic elderly.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible patients were aged 65 years or older with appendicular skeletal muscle mass/height2 2SD below mean of young adults (Baumgartner R, 1998), so with relative muscle mass < 7.26 kg/m2 for men and < 5.5 kg/m2 for women.
  • Patients were not affected by acute illness, severe liver, heart or kidney dysfunction, and had a body weight which had been stable for 6 months

Exclusion Criteria:

  • Subjects with altered glycometabolic control, disthyroidism and other endocrinopathies and cancers, as well as patients treated with steroids and heparin, or with total walking incapacity were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dietary supplement
oral essential amino acid (EAA), whey protein and vitamin D mixture (32 g)
Dietary supplement: dietary supplement
oral essential amino acid (EAA), whey protein and vitamin D mixture
Placebo Comparator: placebo
placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product
Dietary supplement: placebo
placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle mass assessed by dual x-ray absorptiometry
Time Frame: 3 months
muscle mass assessed by dual x-ray absorptiometry
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle strength assessed by handgrip dynamometer
Time Frame: 3 months
muscle strength assessed by handgrip dynamometer
3 months
quality of life assessed by SF-36
Time Frame: 3 months
quality of life assessed by SF-36
3 months
inflammation assessed by C-reactive protein
Time Frame: 3 months
inflammation assessed by C-reactive protein
3 months
malnutrition assessed by Mini Nutritional Assessment
Time Frame: 3 months
malnutrition assessed by Mini Nutritional Assessment
3 months
functionality assessed by activity daily living
Time Frame: 3 months
assessed by activity daily living
3 months
fat mass distribution assessed by DXA
Time Frame: 3 months
body composition assessed by DXA
3 months
GH-IGF-I axsis by Insulin like growth factor -I (IGF-I)
Time Frame: 3 months
Insulin like growth factor -I (IGF-I)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda di Servizi alla Persona di Pavia

Collaborators

University of Pavia

Investigators

  • Principal Investigator: mariangela rondanelli, MD, PhD, University of Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 22, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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