“…Not Intended to Diagnose, Treat, Cure or Prevent Any Disease.” 25 Years of Botanical Dietary Supplement Research and the Lessons Learned

Gurley, Bill J.; Yates, Charles R.; Markowitz, John S.

doi:10.1002/cpt.1131

Cited by 31 publications

(28 citation statements)

References 79 publications

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“…Besides GTE, both of those formulations contained caffeine and a host of other botanical ingredients. Caffeine’s propensity to exacerbate the toxicity of other phytochemicals was recently recognized by the FDA, which banned the sale of pure caffeine powder and dietary supplements containing high caffeine content [60].…”

Section: Discussionmentioning

confidence: 99%

Decaffeinated Green Tea Extract Does Not Elicit Hepatotoxic Effects and Modulates the Gut Microbiome in Lean B6C3F1 Mice

et al. 2019

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The main purpose of this study was to investigate the hepatotoxic potential and effects on the gut microbiome of decaffeinated green tea extract (dGTE) in lean B6C3F1 mice. Gavaging dGTE over a range of 1X–10X mouse equivalent doses (MED) for up to two weeks did not elicit significant histomorphological, physiological, biochemical or molecular alterations in mouse livers. At the same time, administration of dGTE at MED comparable to those consumed by humans resulted in significant modulation of gut microflora, with increases in Akkermansia sp. being most pronounced. Results of this study demonstrate that administration of relevant-to-human-consumption MED of dGTE to non-fasting mice does not lead to hepatotoxicity. Furthermore, dGTE administered to lean mice, caused changes in gut microflora comparable to those observed in obese mice. This study provides further insight into the previously reported weight management properties of dGTE; however, future studies are needed to fully evaluate and understand this effect.

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Section: Discussionmentioning

confidence: 99%

Decaffeinated Green Tea Extract Does Not Elicit Hepatotoxic Effects and Modulates the Gut Microbiome in Lean B6C3F1 Mice

et al. 2019

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“…15,124 Identity and purity of all materials used, regardless of the supplier, should be verified prior to use. 111,130 For example, soy germ isoflavone glucosides incorporated into pasta can be hydrolyzed to aglycones by wheat β-glucosidase. 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.…”

Section: Np Specifications and Integritymentioning

confidence: 99%

“…NP processing methods and final formulation can alter the chemical profile, stability, bioaccessibility, bioavailability, and metabolism of a NP. 111,130 For example, soy germ isoflavone glucosides incorporated into pasta can be hydrolyzed to aglycones by wheat β-glucosidase. 131 In contrast to most preclinical models, humans are generally diverse in genotypes, diets, other behaviors, and environmental exposures.…”

Section: Chemical and Metabolic Factorsmentioning

confidence: 99%

Improving natural product research translation: From source to clinical trial

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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“…describes Health Canada's efforts for monitoring in‐market safety and the need to evolve strategies to remain abreast of consumer selection and use patterns of these products. Finally, Gurley et al . provide, in their elegant state‐of‐the‐art contribution, a 25‐year retrospective, including lessons learned, about the research and regulatory history of botanicals.…”

Section: Contemporary Quality and Safety Issues With Botanicalsmentioning

confidence: 99%

“Green Medicine”: The Past, Present, and Future of Botanicals

Paine

Roe

2018

Clin Pharma and Therapeutics

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Botanicals are plant-derived products that have been consumed by humans for centuries. Today, the marketing and use of botanicals for health and wellness benefits continues to thrive worldwide, with consumers projected to spend more than $140 billion globally by 2024 (Global Analysis, Inc). However, research on the quality and safety of these products has lagged behind sales. Because of this divergence, opportunities abound for collaborations amongst scientists from industry, academia, and government to address these unmet public health needs. Clinical pharmacologists and toxicologists from all of these sectors play critical roles in developing harmonized approaches to achieve the common goal of ensuring botanical products with superior quality and safety.

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“…Not Intended to Diagnose, Treat, Cure or Prevent Any Disease.” 25 Years of Botanical Dietary Supplement Research and the Lessons Learned

Cited by 31 publications

References 79 publications

Decaffeinated Green Tea Extract Does Not Elicit Hepatotoxic Effects and Modulates the Gut Microbiome in Lean B6C3F1 Mice

Decaffeinated Green Tea Extract Does Not Elicit Hepatotoxic Effects and Modulates the Gut Microbiome in Lean B6C3F1 Mice

Improving natural product research translation: From source to clinical trial

“Green Medicine”: The Past, Present, and Future of Botanicals

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