Assessment of Physical Performance With A Supplementation Containing HMB in a Sample of Old Women in Good Health (HMB)

December 2, 2014 updated by: Giuseppe Sergi, University of Padova

Role of Oral Supplementation of Proteins and β-hydroxy-β-methyl Butyrate (HMB) in a Sample of Older Women in Good Health

The purpose of this study is to determine whether a supplementation containing β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a group of older women compared to a non interventional group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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
      • Padua, Italy, 35128
        • University of Padova

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 and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • People over 65 years, not residents in nursing home, in good health
  • Mini Mental State Examination (corrected for scholarity) more than 23

Exclusion Criteria:

  • Previous oral supplementation with proteins or minerals
  • important co-mordidities, such renal or hepatic failure

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: HMB
Group taking oral supplementation with Beta-hydroxy-beta-methylbutyrate
Dietary supplement: HMB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Short Physical Performance Battery
Time Frame: Baseline and after 2 months
Baseline and after 2 months

Collaborators and Investigators

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

Sponsor

University of Padova

Investigators

  • Principal Investigator: Giuseppe Sergi, MD, University of Padova

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

February 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Not Avalaible

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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