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

NCT05767112 | Completed

• 1 other identifier: HMB pharmacokinetics
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Plasma HMB concentration

  Blood samples collected before and multiple times after treatment ingestion for later determination of plasma HMB concentrations

  Up to 720 minutes

Secondary Outcomes (1)

• Urine HMB

  Up to 24 hours

Study Arms (3)

HMB-Ca in water

ACTIVE COMPARATOR

Investigate whether the pharmacological form of HMB has any impact on its bioavailability and pharmacokinetic profile.

Other: Supplement administation

HMB-Ca in capsules

EXPERIMENTAL

Avaliate AUC of HMB-Calcium form supplementation.

Other: Supplement administation

HMB-FA

EXPERIMENTAL

Avaliate AUC of HMB-free acid form supplementation.

Other: Supplement administation

Interventions

Supplement administation OTHER

HMB was administred in 3 different forms: 1) HMB-FA in clear capsules; 2) HMB-Ca in gelatine capsules; 3) HMB-Ca dissolved in water. All treatments provided 1g of HMB. Blood samples were taken before and on multiple time points following ingestion.

HMB-Ca in capsules; HMB-Ca in water; HMB-FA

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18-35 years;
• ≥150 min of moderate to intense physical activity per week

You may not qualify if:

• smoking,
• use of statins, anti-inflammatory, or any other medications that could affect lipid metabolism or blood parameters;
• current or past use of androgenic anabolic steroids;
• diagnosis of gastric or intestinal disorders that could affect nutrient absorption;
• diagnosis of kidney or liver disorders that could affect nutrient metabolisation and elimination;
• any other condition that could be perceived as a potential confounding factor or that could prevent participation in the study.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Physical Education and Sport - USP

São Paulo, 05508030, Brazil

Location

Study Officials

• Heitor R Ribeiro, Bsc

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Crossover Assignment The order of treatments was be randomized.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 14, 2023
• Study Start: October 1, 2015
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2021
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

BR (1)