Alternate Dosing Strategies for Beta-hydroxy-beta-methylbutyrate (HMB) Supplementation: Effect on Plasma HMB Responses
1 other identifier
interventional
11
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedSeptember 16, 2014
September 1, 2014
1 year
July 31, 2013
September 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma HMB Level
Plasma samples collected at 0, 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min after treatment administration
Study Arms (5)
CaHMB Capsule
ACTIVE COMPARATORHMB free acid gelcap
ACTIVE COMPARATORHMB free acid in water
ACTIVE COMPARATORCaHMB powder in water
ACTIVE COMPARATORHMB free acid (oral not in gelcap or water)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Must not be taking amino acid, protein, or HMB supplements; Must not be pregnant; Must not be breastfeeding
You may not qualify if:
- Currently taking amino acid, protein, or HMB supplements; Currently pregnant; Currently breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Iowa State University
Ames, Iowa, 50014, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2013
First Posted
August 2, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
September 16, 2014
Record last verified: 2014-09