NCT02118181

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

April 1, 2014

Enrollment Period

4 months

First QC Date

April 16, 2014

Last Update Submit

December 2, 2014

Conditions

Age Related Muscle Loss

Outcome Measures

Primary Outcomes (1)

  • Change in Short Physical Performance Battery

    Baseline and after 2 months

Study Arms (2)

Control

NO INTERVENTION

HMB

EXPERIMENTAL

Group taking oral supplementation with Beta-hydroxy-beta-methylbutyrate

Dietary Supplement: HMB

Interventions

HMBDIETARY_SUPPLEMENT
HMB

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padova

Padua, Padua, 35128, Italy

Location

Related Publications (1)

  • Berton L, Bano G, Carraro S, Veronese N, Pizzato S, Bolzetta F, De Rui M, Valmorbida E, De Ronch I, Perissinotto E, Coin A, Manzato E, Sergi G. Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial. PLoS One. 2015 Nov 3;10(11):e0141757. doi: 10.1371/journal.pone.0141757. eCollection 2015.

    PMID: 26529601DERIVED

Study Officials

  • Giuseppe Sergi, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, PhD

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-04

Locations

IT(1)