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CompletedNCT01914952

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Metabolic Technologies Inc. · Industry
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCaHMB capsule1.0 gram of CaHMB powder in a gelatin capsule
DIETARY_SUPPLEMENTHMB free acid gelcap0.8 g HMB free acid is a soft gel capsule
DIETARY_SUPPLEMENTHMB free acid mixed in water0.8 g HMB free acid in water
DIETARY_SUPPLEMENTCaHMB in water1.0 g CaHMB powder mixed in water
DIETARY_SUPPLEMENTHMB free acid0.8 g HMB free acid

Timeline

Start date
2013-05-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2013-08-02
Last updated
2014-09-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01914952. Inclusion in this directory is not an endorsement.