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

NCT01914952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-09-16

No results posted yet for this study

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

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

Interventions

DIETARY_SUPPLEMENT

CaHMB capsule

1.0 gram of CaHMB powder in a gelatin capsule

DIETARY_SUPPLEMENT

HMB free acid gelcap

0.8 g HMB free acid is a soft gel capsule

DIETARY_SUPPLEMENT

HMB free acid mixed in water

0.8 g HMB free acid in water

DIETARY_SUPPLEMENT

CaHMB in water

1.0 g CaHMB powder mixed in water

DIETARY_SUPPLEMENT

HMB free acid

0.8 g HMB free acid

Sponsors & Collaborators

  • Metabolic Technologies Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01914952 on ClinicalTrials.gov