An open label pilot study to evaluate the efficacy of Spanish black radish on the induction of phase I and phase II enzymes in healthy male subjects

Abstract

Background: Humans are exposed to toxins which accumulate in the body, and are detoxified primarily in the liver. Studies have shown that cruciferous vegetables (such as radishes) may be beneficial to health by aiding detoxification of toxins in the liver.

Methods: This single-centre, open-label, pilot study investigated the effect of a dietary supplement containing Spanish Black Radish on hepatic function in healthy males by monitoring the profiles of plasma and urine acetaminophen metabolites and serum hormone concentrations at baseline and after 4 weeks of supplementation. A paired t-test was used to compare pre- and post-treatment of plasma and urine acetaminophen metabolite profiles, serum hormone concentrations and safety end points.

Results: Area under the curve (AUC) from 0 to 8 hours for the acetaminophen glucuronide metabolite and unchanged acetaminophen in plasma decreased from baseline to week 4 by 9% (P = 0.004) and 40% (P = 0.010), respectively. The AUC from 0 to 8 hours for acetaminophen sulfate and mercapturate metabolites in the urine increased by 11% (P = 0.010) and 37% (P = 0.024), respectively, from baseline to week 4. The AUC from 0 to 8 hours of serum estradiol-17β decreased by 10% from baseline to week 4 (P = 0.005). All measures of clinical safety remained within acceptable laboratory ranges, however a significant reduction in plasma γ-glutamyl transferase levels was noted after 4 weeks of Spanish Black Radish treatment (P = 0.002).

Conclusions: These changes in metabolite and hormone levels indicate that Spanish Black Radish supplements have a positive influence on the detoxification of acetaminophen suggesting up-regulation of phase I and phase II liver enzymes. This study was sponsored by Standard Process Inc.

Trial registration: ClinicalTrials.gov registration number NCT02137590 (Date of registration: May 12, 2014).

Figures

Figure 1

Disposition of study subjects.

Figure 2

The plasma concentration of acetaminophen metabolites at baseline and 4 weeks. Plasma profiles of acetaminophen glucuronide (A), acetaminophen sulfate (B), NAPQI-GSH (C) and unchanged acetaminophen (D) of pre-acetaminophen dose (0 h) and 2, 4, 6 and 8 h following administration of 1000 mg acetaminophen to subjects (N = 19) at week 0 (♦) and after 4 weeks of SBR supplementation (▀, broken line) (mean ± SEM). *P < 0.001, **P = 0.046, †P = 0.019, and ††P = 0.031, between week 0 and 4 weeks of SBR supplementation.

Figure 3

The urine concentration of acetaminophen metabolites at baseline and 4 weeks. Urine profiles of acetaminophen glucuronide (A), acetaminophen sulfate (B), mercapturate (C) and unchanged acetaminophen (D) of pre-acetaminophen dose (0 h) and 2, 4, 6 and 8 h following administration of 1000 mg acetaminophen to subjects (n = 19) at week 0 (♦) and after 4 weeks of SBR supplementation (▀, broken line) (mean ± SEM). *P = 0.021, **P = 0.019 and †P = 0.035, between week 0 and after 4 weeks of SBR supplementation.

Figure 4

The serum concentration of hormones at baseline and 4 weeks. The serum profiles of free testosterone (A), estradiol-17 β (B) and total testosterone (C) at pre-acetaminophen dose (0 h) and 2, 4, 6 and 8 h following administration of 1000 mg acetaminophen to subjects (n = 19) at week 0 (♦) and after 4 weeks of SBR supplementation (▀, broken line) (mean ± SEM). *P = 0.022, **P = 0.005, †P = 0.007, ††P = 0.040, §P = 0.021 and §§P = 0.046, between baseline and after 4 weeks of SBR supplementation.

Figure 5

The serum concentration of liver enzyme at baseline and 4 weeks. Serum concentration of aspartate transaminase (AST), alanine transaminase (ALT) and γ-glutamyl transferase (GGT) at baseline (0 weeks) and following 4 weeks of SBR supplementation. Although no changes in AST and ALT were seen, a significant reduction in GGT was seen after 4 weeks of supplementation (*P = 0.002).

Pre-publication history