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

Study Overview
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Brief Summary
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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.

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

Conditions
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Focus of the Study is to Examine Plasma HMB Levels After Oral HMB Supplementation

Intervention / Treatment
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* Dietary Supplement: CaHMB capsule
* Dietary Supplement: HMB free acid gelcap
* Dietary Supplement: HMB free acid mixed in water
* Dietary Supplement: CaHMB in water
* Dietary Supplement: HMB free acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CaHMB, HMB free acid, HMB