NCT01793779

Brief Summary

Study Objectives

  1. 1.Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on performance recovery from an acute bout of high intensity resistance exercise.
  2. 2.Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.
  3. 3.Examine the effect of these recovery modalities on markers of muscle damage, inflammation and immune function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

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

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

February 13, 2013

Last Update Submit

July 31, 2013

Conditions

Muscle Damage

Outcome Measures

Primary Outcomes (1)

  • Maximal muscle strength

    The 1-RM tests will be performed to assess maximal muscle strength.

    Change from baseline over 48 hours post-exercise.

Secondary Outcomes (1)

  • Muscle damage

    Change from baseline over 48 hours post-exercise.

Other Outcomes (4)

  • Muscle soreness

    Change from baseline over 48-hours post-exercise.

  • Lower body power

    Change from baseline over 48 hours post-exercise.

  • Immune Markers

    Change from baseline over 48 hours post-exercise.

  • +1 more other outcomes

Study Arms (4)

Control

PLACEBO COMPARATOR

Placebo supplement given prior to exercise and two times per day following exercise

Dietary Supplement: Placebo

cold water immersion

EXPERIMENTAL

Placebo supplement to be give prior to exercise and two times per day following exercise in combination with cold water immersion therapy following exercise

Procedure: cold water immersionDietary Supplement: Placebo

HMB-FA

EXPERIMENTAL

beta-hydroxy-beta-methylbutyrate free acid supplement to be give prior to exercise and two times per day following exercise

Dietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)

cold water immersion group + HMB-FA

EXPERIMENTAL

beta-hydroxy-beta-methylbutyrate free acid supplement give prior to exercise and two times per day following exercise in combination with cold water immersion therapy following exercise

Procedure: cold water immersionDietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)

Interventions

PlaceboDIETARY_SUPPLEMENT
Controlcold water immersion
cold water immersionPROCEDURE
cold water immersioncold water immersion group + HMB-FA
beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)DIETARY_SUPPLEMENT
HMB-FAcold water immersion group + HMB-FA

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least one-year of resistance training experience
  • Free of any physical limitations (determined by health and activity questionnaire).
  • Between the ages of 18 and 35

You may not qualify if:

  • Inability to perform physical exercise (determined by health and activity questionnaire)
  • Taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire).
  • Any chronic illness that causes continuous medical care
  • Taking any type of prescription or over-the-counter medication, having any chronic illness causing you to seek medical care, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida, Sport and Exercise Science

Orlando, Florida, 32816, United States

Location

Related Publications (2)

  • Ascensao A, Leite M, Rebelo AN, Magalhaes S, Magalhaes J. Effects of cold water immersion on the recovery of physical performance and muscle damage following a one-off soccer match. J Sports Sci. 2011 Feb;29(3):217-25. doi: 10.1080/02640414.2010.526132.

    PMID: 21170794BACKGROUND

  • Fuller JC Jr, Sharp RL, Angus HF, Baier SM, Rathmacher JA. Free acid gel form of beta-hydroxy-beta-methylbutyrate (HMB) improves HMB clearance from plasma in human subjects compared with the calcium HMB salt. Br J Nutr. 2011 Feb;105(3):367-72. doi: 10.1017/S0007114510003582. Epub 2010 Dec 7.

    PMID: 21134325BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 18, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations

US(1)