Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Nov;22(5):28-39.

A Plant-Based Dietary Supplement Improves Measures of Metabolic Detoxification and the Quality of Life: A Phase II Multicenter Randomized, Blinded, Placebo-Controlled Clinical Trial

Bassem F El-Khodor  1   2   3   4 , Wei Zang  1   2   3   4 , Heather Gorby  2 , Ashley Dominique  1   2   3   4 , Meghan Hamrock  1   2   3   4 , Brandon Metzer  1   2   3   4 , Alessandra Pecorelli  3 , Saradhadevi Varadharaj  1 , Giuseppe Valacchi  4
Affiliations

A Plant-Based Dietary Supplement Improves Measures of Metabolic Detoxification and the Quality of Life: A Phase II Multicenter Randomized, Blinded, Placebo-Controlled Clinical Trial

Bassem F El-Khodor et al. Integr Med (Encinitas). 2023 Nov.

Abstract

Background: Persistent accumulation and hindered clearance of toxins from tissues over time may promote the development and exacerbation of several diseases. Hepatic metabolic detoxification is a key physiological process responsible for the clearance of toxic substances from the body. A healthy diet with nutritional dietary supplementation may support metabolic detoxification and help mitigate the negative effects of toxin burden.

Methods: A multicenter, randomized, single-blind, controlled trial was conducted to test the effects of a dietary detoxification product (detox; n = 20) versus an active dietary control product (active control; n = 20) on selected biomarkers of metabolic detoxification, general health, and well-being following 28 days of dietary supplementation. Study participants displayed multiple symptoms commonly associated with elevated toxin burden, but otherwise healthy.

Results: The detox group displayed significantly decreased levels of red blood cell total toxic metals, decreased urine total porphyrins, and decreased urine mutagenicity potency compared with baseline. Both the detox and active control groups showed improvements in the symptoms attributed to elevated toxin burden. Fatigue and sleep disruption scores were significantly reduced in the detox group compared with baseline. No significant differences in anthropometric measures and vital signs, and no adverse events or side effects were detected in either group over the study period.

Conclusions: This study demonstrates the benefit of nutritional intervention for supporting metabolic detoxification, evidenced by significant changes in multiple detoxification biomarkers and improvement in questionnaire scores related to quality of life, general health, and well-being.

PubMed Disclaimer

Conflict of interest statement

Author Disclosure Statement B.F.El-K., N.S., W.Z., M.W., A.D., and J.R. are either current or former employees of Standard Process Inc.; the rest of the authors declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
Enrollment Flow Chart at the Two Clinical Sites. Flow Chart Showing the Number, Sex, and Average Age of Patients (± SD) in the Separate Phases of the Study.
Figure 2.
Figure 2.
Active Control Supplement Facts Label
Figure 3.
Figure 3.
Detox Supplement Facts Label
Figure 4.
Figure 4.
The Effect of Detox on (a) MSQ (Participants with Mild and Moderate Scores at Baseline), (b) Fatigue Subscore, (c) Athens Insomnia Scale, and (d) Blood Draw Pain Questionnaires
Figure 5.
Figure 5.
At Baseline, there was a Significant Correlation Between (a) Total Urine Porphyrins and RBC Total Toxic Metals (P = .035), and (b) Total Urine Porphyrins and Urine D-Glucaric Acid Levels (P = .0026). No Correlation was Found Between (c) Total Urine Porphyrins and Urine Mercapturic Acid Levels at Baseline, or (d) Between Total Urine Porphyrins and Urine Mutagenicity Potency at Baseline.
Figure 6.
Figure 6.
The Effects of Detox on (a) Urine D-Glucaric Acid and (b) Mercapturic Acid in Participants with Elevated Total Porphyrins (> 90 nmol/g Creatinine) at Baseline
Figure 7.
Figure 7.
The Effects of Detox on Urine Total Porphyrins Levels in Participants with Total Porphyrins > 90 nmol/g Creatinine at Baseline
Figure 8.
Figure 8.
The Effect of Detox on Mutagenicity Potency (Ames Test for all TA Strains)
Figure 9.
Figure 9.
The Effects of Detox on RBC Toxic Metals Levels: (a) RBC Toxic Metals Values Shown in mcg/g; (b) Percent Change in Toxic Metals Levels Compared to Baseline
See this image and copyright information in PMC

References

    1. Grant DM. Detoxification pathways in the liver. J Inherit Metab Dis. 1991;14(4):421-430. doi:10.1007/BF01797915 - PubMed
    1. Yang C, Kong APS, Cai Z, Chung ACK. Persistent Organic Pollutants as Risk Factors for Obesity and Diabetes. Curr Diab Rep. 2017;17(12):132. doi:10.1007/s11892-017-0966-0 - PubMed
    1. Valkenburg S, Glorieux G, Vanholder R. Uremic Toxins and Cardiovascular System. Cardiol Clin. 2021;39(3):307-318. doi:10.1016/j.ccl.2021.04.002 - PubMed
    1. Sirasanagandla SR, Al-Huseini I, Sofin RGS, Das S. Perinatal Exposure to Bisphenol A and Developmental Programming of the Cardiovascular Changes in the Offspring. Curr Med Chem. 2022;29(24):4235-4250. doi:10.2174/092986 7328666211206111835 - PubMed
    1. Reuben A, Manczak EM, Cabrera LY, et al. . The Interplay of Environmental Exposures and Mental Health: setting an Agenda. Environ Health Perspect. 2022;130(2):25001. doi:10.1289/EHP9889 - PMC - PubMed

LinkOut - more resources