NCT05767112

Pharmacokinetic Profile of the Calcium-salt and Free Acid Forms of β-hydroxy-β-methylbutyrate in Humans

Completed NA Last updated 14 March 2023

What this trial tests

NA trial testing Supplement administation in Healthy in 16 participants. Completed in 20 December 2021.

Timeline

1 October 2015

Primary endpoint
20 December 2016

20 December 2021

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	16
Start date	1 October 2015
Primary completion	20 December 2016
Estimated completion	20 December 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Supplement administation

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 35, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HMB supplementation has been shown to have potential to optimize resistance training responses, which may have important implications for sport, exercise, and health. However, HMB literature shows uncertainties as to which is the superior pharmaceutical form of supplemental HMB (i.e., the calcium salt or the free acid form) in terms of pharmacokinetic profile and bioavailability when consumed by humans. This research project investigated the bioavailability and pharmacokinetics of two different forms of supplemental HMB, namely HMB calcium-salt (HMB-Ca) and HMB Free Acid (HMB-FA). Further, HMB-Ca was provided both diluted in water and encapsulated in gelatine capsules. This pharmacokinetics study adopted a crossover design, open-label design in which male and female participants visited the laboratory on 3 different occasions to receive one the 3 treatments: 1g of HMB; the equivalent of 1g of HMB-Ca in water; the equivalent of 1g of HMB-Ca in gelatine capsules. Venous blood samples were collected before and multiple time points after treatment ingestion, for a period of 12 hours in total. A pre-ingestion midstream urine sample was collected as well as a 24-h post-ingestion total urine sample. All plasma and urine samples were analysed for their HMB concentrations via LC/MS. Time to peak, maximum concentration, area under the curve, half-life time and slope of the incremental phase were calculated to examine the pharmacokinetic profile of HMB and compare the 3 different pharmaceutical forms.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Superior bioavailability of the calcium salt form of β-hydroxy-β-methylbutyrate compared with the free acid form.
   Ribeiro HR, Jardim FG, Roldán MS, de Salles Painelli V, et al · · 2024 · cited 3× · PMID 38564019 · DOI 10.1007/s00726-023-03369-z