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

Metabolic Technologies

Status: Completed

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

Treatments: Dietary Supplement: HMB free acid; Dietary Supplement: CaHMB in water; Dietary Supplement: HMB free acid gelcap; Dietary Supplement: CaHMB capsule; Dietary Supplement: HMB free acid mixed in water

Study type: Interventional

Funder types: Industry

Identifiers

NCT01914952

MTI2013-CS02

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 5 patient groups

CaHMB Capsule

Active Comparator group

Treatment:

Dietary Supplement: CaHMB capsule

HMB free acid gelcap

Active Comparator group

Treatment:

Dietary Supplement: HMB free acid gelcap

HMB free acid in water

Active Comparator group

Treatment:

Dietary Supplement: HMB free acid mixed in water

CaHMB powder in water

Active Comparator group

Treatment:

Dietary Supplement: CaHMB in water

HMB free acid (oral not in gelcap or water)

Active Comparator group

Treatment:

Dietary Supplement: HMB free acid

Sponsor of this trial

Lead Sponsor

Metabolic Technologies