NCT02602561

Brief Summary

The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL injury occurs participation in physical activity is compromised. Reconstructive surgery is often necessary to repair the damage which is then followed by a regimen of physical therapy in order to regain full activity. Nutritional intervention after the surgery could help the patient maintain muscle mass during recovery, thus allowing for a quicker return to normal activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

1.8 years

First QC Date

November 6, 2015

Last Update Submit

March 11, 2019

Conditions

ACL Injury

Keywords

HMBbeta-hydroxy-beta-methylbutyrateACLsurgerymuscle mass

Outcome Measures

Primary Outcomes (1)

  • Skeletal Muscle Mass by impedance measurement using the InBody 720 body composition analyzer

    Measurement of muscle mass will indicate if the active comparator has preserved or increased muscle mass during the post-surgical recovery period.

    Six Weeks

Study Arms (2)

HMB

ACTIVE COMPARATOR

3 g HMB/day

Dietary Supplement: HMB

Placebo

PLACEBO COMPARATOR

Placebo administered similar to the active comparator

Dietary Supplement: Placebo

Interventions

HMBDIETARY_SUPPLEMENT
Also known as: beta-hydroxy-beta-methylbutyrate
HMB
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Complete anterior cruciate ligament (ACL) tear
  • Will benefit from ACL reconstructive surgery
  • Are able to participate in the physical therapy program
  • No previous major knee injuries or surgeries
  • No health conditions affecting muscle mass

You may not qualify if:

  • Incomplete ACL tear
  • Have multiple or bilateral ligament tears
  • Are unable to participate in the physical therapy program
  • Have had previous major knee injuries or surgeries
  • Have health conditions affecting muscle mass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

beta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • John A Rathmacher, PhD

    Metabolic Technologies Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 11, 2015

Study Start

November 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

US(1)