Preventing a Public Health Issue by Quantification of Illegally Added Sexual Enhancers in Natural Dietary Supplements

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The lack of regulation for "natural" dietary supplements raises public health concerns as they may contain undisclosed active ingredients, without proper labelling. Natural libido boosters, marketed as dietary supplements for male sexual function improvement, have been linked to serious side effects, prompting health authorities to issue warnings. Liquid chromatography coupled to mass spectrometry (LC-MS) methods are commonly used to detect non-regulated substances in these supplements. In the present work, an LC-MS/MS method was validated to verify that it provides robust and reliable results, with enough sensitivity (LOD ≤ 10 µg·kg-1 and LOQ ≤ 45 µg·kg-1), precision (RSD ≤ 15%), and accuracy (80–120% recovery). Then, the concentration of sildenafil, tadalafil, vardenafil, yohimbine and desmethyl carbodenafil was evaluated in several dietary supplements commercially available in Spain. 17 samples were analyzed, and 4 presented contaminations of sildenafil, yohimbine or tadalafil. The outstanding results lead to a robust analytical method that can be used to detect and prevent fraud, ensure food security and prevent public health issues.

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  • 10.1211/ijpp.17.1.0005
The ethics of dietary supplements and natural health products in pharmacy practice: A systematic documentary analysis
  • Jan 8, 2010
  • International Journal of Pharmacy Practice
  • Heather Boon + 3 more

Many natural health products and dietary supplements are purchased in pharmacies and it has been argued that pharmacists are in the best position to provide patients with evidence-based information about them. This study was designed to identify how the pharmacist's role with respect to natural health products and dietary supplements is portrayed in the literature. A systematic search was conducted in a variety of health databases to identify all literature that pertained to both pharmacy and natural health products and dietary supplements. Of the 786 articles identified, 665 were broad-coded and 259 were subjected to in-depth qualitative content analysis for emergent themes. Overwhelmingly, support for the sale of natural health products and dietary supplements in pharmacies is strong. Additionally, a role for pharmacist counselling is underscored. But another recurrent theme is that pharmacists are ill-equipped to counsel patients about these products that are available on their shelves. This situation has led some to question the ethics of pharmacists selling natural health products and dietary supplements and to highlight the existence of an ethical conflict stemming from the profit-motive associated with sales of natural health products and dietary supplements. This analysis raises concerns about the ethics of natural health products and dietary supplements being sold in pharmacies, and about pharmacists being expected to provide counselling about products of which they have little knowledge.

  • Single Book
  • Cite Count Icon 1
  • 10.1039/9781839166112
Dietary Supplements with Antioxidant Activity
  • Jun 9, 2023

Non-communicable diseases, such as cardiovascular disease, cancer, diabetes, obesity, and hypertension, represent the cause of 60% of all deaths around the globe. With proper diet and natural dietary antioxidant supplements, these diseases can be prevented by up to 40% according to the British Nutrition Foundation. This book provides a comprehensive overview of the literature on the health benefits of natural dietary antioxidant supplements. It presents state-of-the-art research and information as well as the global regulations, labelling, and health claims of natural dietary antioxidant supplements. Written by expert authors, the wealth of research is arranged by disease type rather than by supplement type making it much more useful to the reader. Filling a gap in the literature, the book is aimed at researchers and professionals working in food chemistry, nutrition, and health benefits.

  • Research Article
  • Cite Count Icon 10
  • 10.1007/s00216-015-8462-3
A sensitive chemiluminescent immunoassay for point-of-care testing of repaglinide in natural dietary supplements and serum.
  • Feb 6, 2015
  • Analytical and Bioanalytical Chemistry
  • Lei Zheng + 8 more

For point-of-care testing of the illegal fortification of repaglinide (Rep) in natural dietary supplements, a competitive chemiluminescent immunoassay (CLIA) was established, using a horseradish peroxidase (HRP)-luminol-H2O2 system for signal amplification. Polyclonal antibodies for Rep were produced via immunization technique. Following optimization of the enzyme reaction time and concentrations of antibody and coating antigen, the method showed a limit of quantification (LOQ) of 1.0ng/mL in PBS and limit of detection (LOD) of 8.3ng/mL in serum and 6.0ng/mL in blank tablets. When applied in natural dietary supplements, the method provided results consistent with those from HPLC, suggesting that the proposed method could be used for rapid screening of Rep in natural dietary supplements and detecting Rep in serum after administration.

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  • Research Article
  • Cite Count Icon 9
  • 10.1186/1550-2783-9-28
Consumption and biochemical impact of commercially available plant-derived nutritional supplements. An observational pilot-study on recreational athletes
  • Feb 6, 2012
  • Journal of the International Society of Sports Nutrition
  • Paolo Borrione + 6 more

BackgroundA growing consumption of natural (plant-derived) dietary supplements with ergogenic aims, with particular regard for ecdysteroids, phytoestrogens and vegetal sterols, has been registered over the last years among “recreational” athletes. The present study was carried out in order to evaluate the real knowledge of plant-derived nutritional supplements among physically active people as well as their real consumption. Additional aim was to evaluate the effects of these supplements on the health profile of the users.MethodsTwenty-three trained subjects who habitually used natural dietary supplements, and 30 matched controls were analyzed for plasma biochemical markers and hormonal profile.ResultsThe laboratory tests revealed the absence of any sign of organ toxicity/damage in both athletes and controls. On the contrary, hormone profiles revealed marked alterations in 15 (65%) out of the 23 of investigated athletes. Specifically, 10 males presented increased plasma levels of progesterone, 15 subjects presented abnormal estrogen levels, including 5 (2 F and 3 M) presenting a “dramatic” increased estrogen values and 2 two males with increased estrogen levels, increased testosterone levels and associated suppression of luteinizing hormone and follicle-stimulating hormone.ConclusionsThe results of the present study highlighted that the habitual consumption of plant-derived nutritional supplements is frequently associated with significant hormonal alterations both in male and female subjects. Although these biochemical alterations were not associated with signs or symptoms of organ toxicity/damage at the moment of the study, it cannot be excluded that, in the mid/long-term, these subjects would suffer of health problems secondary to chronic exposure to heavily altered hormonal levels. Further large scale studies are needed to confirm the results of this pilot study as well as to investigate the biological mechanisms at the base of the observed hormonal alterations.

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A new method for safety monitoring of natural dietary supplements--quality profile
  • Jul 1, 2008
  • Chinese Journal of Preventive Medicine
  • Juan Wang + 3 more

A new method for safety monitoring of natural dietary supplements--quality profile was proposed. It would convert passive monitoring of synthetic drug to active, and guarantee the security of natural dietary supplements. Preliminary research on quality profile was completed by high performance liquid chromatography (HPLC) and mass spectrometry (MS). HPLC was employed to analyze chemical constituent profiles of natural dietary supplements. The separation was completed on C18 column with acetonitrile and water (0.05% H3PO4) as mobile phase, the detection wavelength was 223 nm. Based on HPLC, stability of quality profile had been studied, and abnormal compounds in quality profile had been analyzed after addition of phenolphthalein, sibutramine, rosiglitazone, glibenclamide and gliclazide. And by MS, detector worked with ESI +, capillary voltage: 3.5 kV, cone voltage: 30 V, extractor voltage: 4 V, RF lens voltage: 0.5 V, source temperature: 105 degrees C, desolvation temperature: 300 degrees C, desolvation gas flow rate: 260 L/h, cone gas flow rate: 50 L/h, full scan mass spectra: m/z 100-600. Abnormal compound in quality profile had been analyzed after addition of N-mono-desmethyl sibutramine. Quality profile based on HPLC had good stability (Similarity > 0.877). Addition of phenolphthalein, sibutramine, rosiglitazone, glibenclamide and gliclazide in natural dietary supplements could be reflected by HPLC, and addition of N-mono-desmethyl sibutramine in natural dietary supplements could be reflected by MS. Quality profile might monitor adulteration of natural dietary supplements, and prevent addition of synthetic drug after "approval".

  • Research Article
  • Cite Count Icon 8
  • 10.1007/s13668-021-00388-8
Nutrition, Immunology, and Kidney: Looking Beyond the Horizons.
  • Jan 26, 2022
  • Current Nutrition Reports
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Chronic kidney disease (CKD) is epidemic throughout the word. Despite various novel therapeutic opportunities, CKD is still associated with high morbidity and mortality. In CKD, patient's chronic inflammation is frequent and related with adverse outcomes. Both innate and adaptive immunity are dysfunctional in CKD. Therefore, it is plausible to interfere with dysfunctional immunity in these patients. In the current review, we present the updated experimental and clinical data summarizing the effects of nutritional interventions including natural products and dietary supplements on immune dysfunction in the context of CKD. Nutritional interventions including natural products and dietary supplements (e.g., curcumin, sulforaphane, resistant starch, anthocyanin, chrysin, short chain fatty acids, fish oil resistant starch) slow down the inflammation by at least 6 mechanisms: (i) decrease nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB); (ii) decrease NLR family pyrin domain containing 3 (NLRP3); (iii) decrease interleukin-1 (IL-1), decrease interleukin-6 (IL-6) secretion; (iv) decrease polymorphonuclear priming); (v) promote anti-inflammatory pathways (nuclear factor-erythroid factor 2-related factor 2 (NFR2); (vi) increase T regulatory (Tregs) cells). Natural products and dietary supplements may provide benefit in terms of kidney health. By modulation of nutritional intake, progression of CKD may be delayed.

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Validation of sibutramine and phenolphthalein determination by HPLC-PDA in natural dietary supplements for body-weight reduction
  • Dec 3, 2024
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  • T.N.V Nguyen + 5 more

The worldwide demand for natural dietary supplements for body-weight reduction is increasing, because they are commonly believed to be safe. However, the abundance and diversity of available dietary supplements impede their quality control, potentially posing multiple health risks. A simple and cost-effective procedure involving high-performance liquid chromatography photodiode array detector (HPLC-PDA) and homogeneous liquid– liquid extraction (LLE) of samples were applied to analyze simultaneously sibutramine and phenolphthalein in natural dietary supplements used for body-weight reduction. The recoveries obtained ranged from 91.87% to 96.46%. The limits of detection and quantification were 0.33 μg/mL and 1 μg/mL, respectively. The phenolphthalein and sibutramine contents were in the range of 0.009-5.601 mg/tablet and 0.005-4.409 mg/ tablet, respectively. The results showed that the proposed HPLC-PDA method was precise and accurate. It was simple to apply to identify and quantify these and other adulterants in natural dietary supplements.

  • Front Matter
  • Cite Count Icon 5
  • 10.1053/j.ajkd.2012.08.018
A Decade After the KDOQI CKD Guidelines: Impact on Medication Safety
  • Oct 13, 2012
  • American Journal of Kidney Diseases
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A Decade After the KDOQI CKD Guidelines: Impact on Medication Safety

  • Research Article
  • Cite Count Icon 30
  • 10.1002/jms.1899
An LC–MS screening method with library identification for the detection of steroidsin dietary supplements
  • Mar 1, 2011
  • Journal of Mass Spectrometry
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For many years anabolic-androgenic steroids (AAS) are by far the most frequently detected pharmacological substances in doping control. In order to improve their performances, professional sportsmen are often tempted to take dietary supplements. However, due to the frequent and widespread occurrence of contaminated supplements, the use of such products is not without risk for the athletes involved. In order to minimize the chances of an unattended positive doping test or serious health problems, fast and reliable screening methods for the detection of anabolic steroids in dietary supplements are needed. A general screening procedure requires the fast and unambiguous detection of a large range of steroids. Gas chromatography-mass spectrometry (GC-MS) has been used intensively in the detection of doping substances for the past 40 years. Over time, many laboratories have delivered spectra to be included in standard reference databases, one of which is maintained by the National Institute of Standards and Technology (NIST) (Gaithersburg, MD, USA). In recent years, however, liquid chromatography coupled to mass spectrometry (LC-MS) has gained popularity. Unfortunately, existing GC-MS libraries are not applicable to LC-MS analysis. In the present study, a new mass spectral library of 88 steroids was developed, along with a fast UPLC-MS method. For the construction of this mass spectral library, three different mass spectra were measured for each steroid, with a sample cone voltage of 30, 60 and 100 V, respectively. This method was then successfully tested on contaminated dietary supplements which had previously been tested by means of a targeted LC-MS/MS method. Overall, the library search was shown to identify the same compounds as the MRM method.

  • Research Article
  • Cite Count Icon 26
  • 10.1080/09637480701777977
Re-thinking the dietary supplement laws and regulations 14 years after the Dietary Supplement Health and Education Act implementation
  • Dec 9, 2008
  • International Journal of Food Sciences and Nutrition
  • Tao Jiang

In 1994, after intensive lobbying by the supplement industry, US federal legislation passed the Dietary Supplement Health and Education Act, and essentially removed so-called ‘dietary supplements’ from the US Food and Drug Administration control. Some companies are marketing herbal medications in the USA as dietary supplements. Even some dietary supplement manufacturers produce a ‘mimic drug’ rather than a ‘dietary supplement’. The US Food and Drug Administration is able to do nothing except wait for the next incident to occur before other dietary supplement products have also caused serious effects. In the present article, the author discusses international regulations and laws of dietary supplements, and hopes to see more new laws and regulations to assure people of continued access to high-quality natural healthcare products and dietary supplements.

  • Book Chapter
  • 10.1039/bk9781839166112-00011
The Global Regulations and Health Claims on Natural Dietary Antioxidant Supplements
  • Jun 9, 2023
  • Jerzy Zawistowski

Dietary supplements may have different names in various countries. The terms include natural health products, health foods, herbal supplements, and traditional medicine. However, the form is common and includes capsules, tablets, tinctures, powders, or pills at a daily dosage level. The dietary supplement is not represented for use as a conventional food or as the sole item of a meal or diet or as a replacement for drugs and medicines. The antioxidant supplements that contain catechins, anthocyanins, carotenoids, isoflavones, and various other phytochemicals are an important group of products, which may provide protection of cells from oxidative stress, support antioxidant activity, and enable the maintenance of good eyesight. The regulatory framework and health claims on antioxidant supplements are the focus of this chapter.

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  • Research Article
  • Cite Count Icon 78
  • 10.1155/2011/174978
Acute Liver Failure Caused by ‘Fat Burners’ and Dietary Supplements: A Case Report and Literature Review
  • Jan 1, 2011
  • Canadian Journal of Gastroenterology
  • Y Radha Krishna + 4 more

Globally, people are struggling with obesity. Many effective, nonconventional methods of weight reduction, such as herbal and natural dietary supplements, are increasingly being sought. Fat burners are believed to raise metabolism, burn more calories and hasten fat loss. Despite patient perceptions that herbal remedies are free of adverse effects, some supplements are associated with severe hepatotoxicity. The present report describes a young healthy woman who presented with fulminant hepatic failure requiring emergent liver transplantation caused by a dietary supplement and fat burner containing usnic acid, green tea and guggul tree extracts. Thorough investigation, including histopathological examination, revealed no other cause of hepatotoxicity. The present case adds to the increasing number of reports of hepatotoxicity associated with dietary supplements containing usnic acid, and highlights that herbal extracts from green tea or guggul tree may not be free of adverse effects. Until these products are more closely regulated and their advertising better scrutinized, physicians and patients should become more familiar with herbal products that are commonly used as weight loss supplements and recognize those that are potentially harmful.

  • Research Article
  • Cite Count Icon 19
  • 10.1111/bcp.12061
Nutraceuticals: is there good science behind the hype?
  • Feb 5, 2013
  • British Journal of Clinical Pharmacology
  • Jeroen Schmitt + 1 more

Nutraceuticals: is there good science behind the hype?

  • Research Article
  • Cite Count Icon 5
  • 10.1155/2021/8889423
A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary Supplements.
  • Aug 25, 2021
  • International Journal of Analytical Chemistry
  • Qi Liang + 8 more

Herbal weight loss drugs are becoming more widely used in the fight against obesity, but ineffective regulation of these products have resulted in harmful additives. These products may contain adulterants such as sibutramine hydrochloride that may result in serious adverse health events including death. This work established a color precipitation reaction-based rapid screening method for illegal adulteration of sibutramine hydrochloride in natural herbal medicines (NHM) and dietary supplements (DS). While a variety of chromatography- and electrophoresis-based systems have been reported to measure this analyte, they generally suffer from high costs, complicated sample preparation, and a costly analytical infrastructure. In contrast, we present a simple, handheld kit to assay for sibutramine. The performance metrics of this tool include an average detection time of approximately 3 minutes, which is markedly shorter than conventional methods (HPLC or HPLC-MS, etc.), a detection limit of 0.1 mg per aliquot, and an accuracy of 99.02% (n = 820). More strikingly, the sensitivity is 100% (n = 278), and the specificity is 98.52% (n = 542). The rapid test kit developed from this screening method was evaluated by FDA. In summary, this screening method is a rapid, simple, and low-cost tool for the detection of sibutramine in NHM and DS with superior selectivity and sensitivity. For these reasons, this method is especially suitable for underdeveloped settings because it can be employed onsite without any instrumentation. In addition, this approach could rapidly exclude most of the negative samples to boost efficiency in large-scale samples assay. If necessary, positive samples can undergo further alternate testing methods to confirm the positive results of sibutramine hydrochloride content.

  • Research Article
  • Cite Count Icon 35
  • 10.1186/1472-6882-14-388
The use of complementary and alternative medicine after the completion of hospital treatment for colorectal cancer: findings from a questionnaire study in Denmark
  • Oct 10, 2014
  • BMC Complementary and Alternative Medicine
  • Nina Nissen + 3 more

BackgroundLittle is known about the use of complementary and alternative medicine (CAM) for colorectal cancer, despite the high incidence of colorectal cancer and the frequency of CAM use for cancer-related symptoms. This is the first Danish study to examine the use of CAM by individuals who completed hospital treatment for colorectal cancer.MethodsIn 2011–12, a pragmatic trial on energy healing as rehabilitation after colorectal cancer was conducted in Denmark with participants who had completed cancer-related hospital treatment within the past 18 months prior to study inclusion. As part of the trial, participants (n = 247) completed a questionnaire on the use, motivations, pathways and perceived benefits of CAM. Socio-demographic information was obtained via the Danish National Patient Registry and self-report. Descriptive statistics were generated, using SPSS, version 18, and logistic regression analysis was carried out.ResultsOf 247 individuals, 49.4% used some form of CAM in the past month. Nearly half of the CAM users (49.2%) used natural medicines and/or dietary supplements only; 32% consulted an alternative therapist; 18.9% used both. Those who consulted alternative therapists were most commonly women (OR: 3.36; p = .002; CI: 1.54-7.33) with high educational levels (OR: 2.77; p = 0.010; CI: 1.28-6.01); more women than men used natural medicines and/or dietary supplements (OR: 1.83; p = .047; CI: 1.01-3.30) independent of educational levels. A majority commenced CAM on their own initiative; CAM was predominantly used to achieve better physical wellbeing. Beneficial effects were reported particularly in relation to physical health; few harmful effects were reported. Of those using CAM, 51.5% did not disclose its use to their physician; 8.5% of participants reported to have been asked by their physician about CAM use.ConclusionThe use of CAM following completion of hospital treatment for colorectal cancer seems widespread in Denmark. The identified extensive CAM use suggests a need for more reliable and diverse information about CAM for both patients and biomedical providers, and improved communication about its use in the clinical context.Electronic supplementary materialThe online version of this article (doi:10.1186/1472-6882-14-388) contains supplementary material, which is available to authorized users.

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