Follow that botanical: Challenges and recommendations for assessing absorption, distribution, metabolism and excretion of botanical dietary supplements

Waidyanatha, Suramya; Ryan, Kristen; Roe, Amy L.; Wang, Jia; Paine, Mary F.; Ferguson, Stephen S. G.; Gurley, Bill J.; Welch, Kevin; Chow, Moses S. S.; DeVito, Michael J.; Rider, Cynthia V.

doi:10.1016/j.fct.2018.08.062

“…1 ). Previous studies have shown that oral administration of G. biloba extract preparations results in high concentrations of ginkgo flavonoid metabolites and terpene trilactones in the plasma of rodents and humans, and several of these compounds can cross the blood-brain barrier and enter the central nervous system of rats [ [34] , [35] , [36] , [37] ], indicating their potential importance in mediating the pharmacological effects of G. biloba extract preparations in the brain. Specifically, Rangel-Ordóñez et al.…”

Section: Discussionmentioning

confidence: 99%

Neuroprotective effects of Ginkgo biloba dropping pills in Parkinson’s disease

Du

¹

,

Zhang

²

,

Li

³

et al. 2021

Journal of Pharmaceutical Analysis

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Parkinson’s disease (PD) is the second most common neurodegenerative disease in the world; however, it lacks effective and safe treatments. Ginkgo biloba dropping pill (GBDP), a unique Chinese G. biloba leaf extract preparation, exhibits antioxidant and neuroprotective effects and has a potential as an alternative therapy for PD. Thus, the aims of this study were to evaluate the effects of GBDP in in vitro and in vivo PD models and to compare the chemical constituents and pharmacological activities of GBDP and the G. biloba extract EGb 761. Using liquid chromatography tandem-mass spectrometry, 46 GBDP constituents were identified. Principal component analysis identified differences in the chemical profiles of GBDP and EGb 761. A quantitative analysis of 12 constituents showed that GBDP had higher levels of several flavonoids and terpene trilactones than EGb 761, whereas EGb 761 had higher levels of organic acids. Moreover, we found that GBDP prevented 6-hydroxydopamine-induced dopaminergic neuron loss in zebrafish and improved cognitive impairment and neuronal damage in methyl-4-phenyl-1,2,3,6-tetrahydropyridine-induced PD mice. Although similar effects were observed after EGb 761 treatment, the neuroprotective effects were greater after GBDP treatment on several endpoints. In addition, in vitro results suggested that the Akt/GSK3β pathway may be involved in the neuroprotective effects of GBDP. These findings demonstrated that GBDP have potential neuroprotective effects in the treatment of PD.

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“…122,123 Characterization sufficient for the detection of such minor components, known or unknown, is therefore critical for quality control and for monitoring batch-to-batch variation and stability. 17,22,114,125 3.2 | Chemical and metabolic factors ADME is a multistep, dynamic biological process that may be modified by product characteristics as well as by host characteristics 115,[126][127][128][129] including physiology and behavior. 14,124 Descriptions of approaches to NP selection and characterization have been published recently.…”

Section: Np Specifications and Integritymentioning

confidence: 99%

Improving natural product research translation: From source to clinical trial

Sorkin

¹

,

Kuszak

²

,

Bloss

³

et al. 2019

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While great interest in health effects of natural product (NP) including dietary supplements and foods persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. More effective bridging from NP research to CT was the goal of a Septe mber, 2018 trans disci plina ry workshop. Participants emphasized that replicability and likelihood of successful translation depend on rigor in experimental design, interpretation, and reporting across the continuum of NP research. Discussions spanned good practices for NP characterization and quality control; use and interpretation of models (computational through in vivo) with strong clinical predictive validity; controls for experimental artefacts, especially for in vitro interrogation of bioactivity and mechanisms of action; rigorous assessment and interpretation of prior research; transparency in all reporting; and prioritization of research questions. Natural product clinical trials prioritized based on rigorous, convergent supporting data and current public health needs are most likely to be informative and ultimately affect public health. Thoughtful, coordinated implementation of these practices should enhance the knowledge gained from future NP research. K E Y W O R D S clinical predictive validity, dietary supplements, model systems, rigor and replicability, value of information | 43 SORKIN et al.still provide invaluable guidance, the results of such trials are often met with concerns that different design choiceswhether of product, dose, timing, participant eligibility criteria, outcomes, etc.-might have yielded a substantially different result. Each interventional trial represents a substantial investment, with well-powered Phase III CTs typically consuming more than $10 million and many person-years. 9,10 Additionally, as time and funds are limited, and participant pools may also be constrained, a decision to invest in a CT often precludes pursuing other research questions, 11 which may provide more useful public health-relevant knowledge than an RCT with an insufficient evidence base.

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“…The absorption, distribution, metabolism, and excretion (ADME) is a multistep, dynamic biological process that may be modified by product characteristics as well as by host characteristics (115,(127)(128)(129)(130) including physiology and behavior. NP processing methods and final formulation can alter the chemical profile, stability, bioaccessibility, bioavailability, and metabolism of a NP (110,131).…”

Section: Chemical and Metabolic Factorsmentioning

confidence: 99%

Improving Natural Product Research Translation: from Source to Clinical Trial

Sorkin¹,

Kuszak²,

Fukagawa³

et al. 2019

Preprint

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While great interest in health effects of natural product (NP) including dietary supplements and foods persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. More effective bridging from NP research to CT was the goal of a https://events-support.com/events/Natural_Product_Clinical_Trials. Participants emphasized that replicability and likelihood of successful translation depend on rigor in experimental design, interpretation, and reporting across the continuum of NP research. Discussions spanned good practices for NP characterization and quality control; use and interpretation of models (computational through in vivo) with strong clinical predictive validity; controls for experimental artefacts, especially for in vitro interrogation of bioactivity and mechanisms of action; rigorous assessment and interpretation of prior research; transparency in all reporting; and prioritization of research questions. Natural product clinical trials prioritized based on rigorous, convergent supporting data and current public health needs are most likely to be informative and ultimately affect public health. Thoughtful, coordinated implementation of these practices should enhance the knowledge gained from future NP research.

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Follow that botanical: Challenges and recommendations for assessing absorption, distribution, metabolism and excretion of botanical dietary supplements

Cited by 19 publications

References 70 publications

Neuroprotective effects of Ginkgo biloba dropping pills in Parkinson’s disease

Neuroprotective effects of Ginkgo biloba dropping pills in Parkinson’s disease

Improving natural product research translation: From source to clinical trial

Improving Natural Product Research Translation: from Source to Clinical Trial

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