Alternate Dosing Strategies for Beta-hydroxy-beta-methylbutyrate (HMB) Supplementation: Effect on Plasma HMB Responses

September 15, 2014 updated by: Metabolic Technologies Inc.

The purpose of this study is to examine the rise in plasma Beta-hydroxy-beta-methylbutyrate (HMB) after the dietary supplement has been administered in different forms. Prior studies have indicated that form of administration affects bioavailability of the HMB supplement. Therefore the current study will examine the bioavailability of a single dose of HMB given as:

  • 1.0g CaHMB in gelatin capsule
  • 0.8 g HMB free acid in a gelcap
  • 0.8 g HMB free acid in water
  • 1.0 g CaHMB in water
  • 0.8 g HMB free acid

The randomized study will be a crossover design and each study subject will undergo the experimental protocol for each of the supplementation forms. Because of the different administration forms, the study will be an open label study. Briefly, the fasted participants will report to the laboratory in the morning. After an initial blood sample is taken, the dose of HMB will be administered. Blood will then be samples at 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min post administration. A 24 h complete urine collection will also be performed. Participants will be given a light sack lunch 4 h after administration of the dosage and will remain at the laboratory through the 360 min sampling. Participants will then be allowed to leave the laboratory and return for the 720 min sampling after which the participants can eat an normal evening meal. Participants will return to the laboratory fasted the next morning for the final sample. A minimum 48 h washout period will be required before the next dosage form is administered and the process repeated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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

  • United States
    • Iowa
      • Ames, Iowa, United States, 50014
        • Iowa State University

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must not be taking amino acid, protein, or HMB supplements; Must not be pregnant; Must not be breastfeeding

Exclusion Criteria:

  • Currently taking amino acid, protein, or HMB supplements; Currently pregnant; Currently breastfeeding

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CaHMB Capsule
Dietary supplement: CaHMB capsule
1.0 gram of CaHMB powder in a gelatin capsule
Active Comparator: HMB free acid gelcap
Dietary supplement: HMB free acid gelcap
0.8 g HMB free acid is a soft gel capsule
Active Comparator: HMB free acid in water
Dietary supplement: HMB free acid mixed in water
0.8 g HMB free acid in water
Active Comparator: CaHMB powder in water
Dietary supplement: CaHMB in water
1.0 g CaHMB powder mixed in water
Active Comparator: HMB free acid (oral not in gelcap or water)
Dietary supplement: HMB free acid
0.8 g HMB free acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma HMB Level
Time Frame: Plasma samples collected at 0, 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min after treatment administration
Plasma samples collected at 0, 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min after treatment administration

Collaborators and Investigators

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

Sponsor

Metabolic Technologies Inc.

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

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MTI2013-CS02

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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