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

Not Applicable

Completed

• Conditions: Focus of the Study is to Examine Plasma HMB Levels After Oral HMB Supplementation
• Interventions: Dietary Supplement: HMB free acid; Dietary Supplement: CaHMB in water; Dietary Supplement: CaHMB capsule; Dietary Supplement: HMB free acid gelcap; Dietary Supplement: HMB free acid mixed in water

• Registration Number: NCT01914952
• Lead Sponsor: Metabolic Technologies Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HMB free acid (oral not in gelcap or water)	HMB free acid	-
CaHMB powder in water	CaHMB in water	-
CaHMB Capsule	CaHMB capsule	-
HMB free acid gelcap	HMB free acid gelcap	-
HMB free acid in water	HMB free acid mixed in water	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Iowa State University; 🇺🇸 Ames, Iowa, United States