An Open-label Clinical Study to Determine the Effect of Enhanced Absorption Formula (MB EnzymeProandreg;) on the Bioavailability of Whey Protein in Healthy Male Subjects

Abstract

Background: Several reports recommend that the dietary supplementation with Whey Protein (WP) in liquid form has been a popular choice for most of the individuals, especially athletes. Some product labels suggest a high serving size of 50 g for WP. Nevertheless, due to the limited endogenous digestive enzymes output and fast transit time, the average amount digested and absorbed may be approximately 15 g, thereby restricting protein bioavailability. The objective of this study was to find out whether MB EnzymePro®, a unique patent-pending Enhanced Absorption FormulaTM (EAF) of digestive proteases, significantly increases the digestion and absorption of WP, ultimately increasing bioavailability. The study also investigated its usefulness in significantly altering nitrogen (N2) balance and C-Reactive Protein (CRP) levels. Methods: An open-label, three-period, crossover, an oral bioavailability study was performed in healthy male subjects under fasting conditions. The study was carried out as per the Institutional Ethics Committee (IEC) approved study protocol and was registered with Clinical Trials Registry-India (CTRI). The study involved twenty-four subjects (age 20-36 years, BMI 20.0-24.0 kg/m2). A single dose of 50 g of WP alone (control), with one capsule (treatment A) and two capsules (treatment B) of MB EnzymePro® was administered to each group comprising 8 subjects. Blood samples were collected at specific time points up to 4 h for amino acid profile and CRP analysis. A total of 17 amino acids were quantified. Urine was collected after up to 24 h for total N2 analysis. Pharmacokinetic parameters were calculated using Phoenix® WinNonlin®. Results: The overall protein bioavailability enhancement was more than 50% for WP with MB EnzymePro®. A significant increase of more than 60% in BCAAs was noticed in the MB EnzymePro® treatment. The N2 balance and CRP levels were significantly better in the treated groups than the control group. Conclusion: Compared with the control condition, a patent-pending blend of digestive proteases (MB EnzymePro®) increased the digestion and absorption (bioavailability) of WP with improved N2 balance and reduced CRP levels.