A 28-Day Repeated Dose Toxicological Study of an Aqueous Extract of <i>Morus Alba</i> L.

Marx, Tennille; Glávits, Róbert; Endres, John R.; Palmer, Philip A.; Clewell, Amy E.; Murbach, Timothy S.; Hirka, Gábor; Pasics, Ilona

doi:10.1177/1091581816670597

Cited by 25 publications

(11 citation statements)

References 31 publications

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“…These findings suggest that daily administration of Q-Actin to rats at doses up to 1000 mg/kg bw/day (the highest dose tested) for 90-days was well tolerated. The findings of this study are supported by a previous 28-day rat toxicity study in which mulberry leaf extract containing iminosugar (5% DNJ) did not reveal any adverse effects and the NOAEL was found to be 4000 mg/kg bw/day [ 22 ].…”

Section: Discussionsupporting

confidence: 85%

“…The biological activities of iminosugar does not indicate potential for toxicity. A 28-day repeated dose toxicity study in rats using a commercially available mulberry leaf extract standardized to 5% DNJ, found no safety concerns [ 22 ]. This study concluded that the no observed adverse effect level was 4000 mg/kg bw/day (the highest dose tested), supporting the safety of DNJ and similar iminosugars.…”

Section: Discussionmentioning

confidence: 99%

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Safety assessment of a standardized cucumber extract (Q-Actin™): Oral repeat-dose toxicity and mutagenicity studies

Kothari¹,

Saravana²,

Muthusamy³

et al. 2018

Toxicology Reports

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Cucumus sativus (cucumber) is one of the most widely consumed fruit vegetables worldwide. Recent discovery of iminosugars in commonly consumed fruits and vegetables has promoted the interest in isolating these compounds and understanding the potential benefits to human health. The objective of the present study was to investigate the general toxicity and mutagenic effects of an aqueous extract of cucumber (Q-Actin), standardized to ≥1% (1–2%) ido-BR1 iminosugar. Single dose of Q-Actin was well tolerated without mortality at 2000 mg/kg body weight (bw) in Sprague Dawley rats. Oral (gavage) administration of Q-Actin up to 1000 mg/kg bw/day was well tolerated followed by repeated administration for a maximum period of 90 days in Sprague-Dawley rats. There were no treatment related changes in clinical observations, ophthalmic examinations, body weights and body weight gains or feed consumption, clinical chemistry and pathological changes compared to control. The mutagenicity as evaluated by Ames assay, in vitro chromosomal aberration test and in vivo micronucleus assay did not reveal any potential of Q-Actin to induce genotoxicity. The results showed that Q-Actin is well tolerated in general toxicity studies and did not induce mutagenicity. The no-observed-adverse-effect level (NOAEL) of the standardized aqueous cucumber extract (Q-Actin) is considered to be ≥1000 mg/kg bw/day, followed by repeated administration for90 days.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Safety assessment of a standardized cucumber extract (Q-Actin™): Oral repeat-dose toxicity and mutagenicity studies

Kothari¹,

Saravana²,

Muthusamy³

et al. 2018

Toxicology Reports

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“…Our safety results are consistent with the findings of previous studies, which showed that the singular ingredients used in Tribitor ® (MarMar Investment Sp. z o.o., Warsaw, Poland) do not have any serious side effects and that the gastrointestinal side effects are rare and diminish upon extended use of the products [ 33 , 34 ]. Taking into account the issues of cost and the potential side effects of other weight-loss drugs available, Tribitor ® (MarMar Investment Sp.…”

Section: Discussionmentioning

confidence: 99%

A Synergistic Formulation of Plant Extracts Decreases Postprandial Glucose and Insulin Peaks: Results from Two Randomized, Controlled, Cross-Over Studies Using Real-World Meals

Adamska-Patruno

Billing-Marczak²,

Orłowski³

et al. 2018

Nutrients

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This study investigated the efficacy of a plant-derived dietary supplement with respect to decreasing postprandial glucose and insulin peaks after the intake of real-world meals. Two randomized, double-blind, placebo-controlled, cross-over experiments were conducted on healthy subjects who received a supplement containing extracts of white mulberry, white bean, and green coffee or one containing the three extracts with added fibre before consuming high-GI/GL (glycaemic index/glycaemic load) meals. In study one, 32 subjects received an investigational product/placebo before a standardized meal at two visits. In study two, 150 subjects received an investigational product/placebo before five different standardized meals. Postprandial glucose and insulin concentrations were lower 20–35 min after meal intake among subjects taking the investigational product, and fewer episodes of postprandial reactive hypoglycaemia were noted. For example, after consuming breakfast cereal with milk, lower glucose peaks were observed for the investigational product (vs. placebo) after 20 min (100.2 ± 1.97 vs. 112.5 ± 3.12 mg/dL, respectively; p < 0.01); lower insulin peaks were noted at the same time point (45.9 ± 4.02 IU/mL vs. 68.2 ± 5.53 IU/mL, respectively, p < 0.01). The combined formulation decreases the adverse consequences of high-GI/GL meal consumption. It can be an effective dietary supplement for the management of metabolic syndrome and type 2 diabetes mellitus.

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“…Moreover, intraperitoneal administration of 300 and 2,000 mg/kg bw of mulberry leaf ethanol extracts for 14 days induced a greater degree of toxicity toward biochemical, hematological, and histological parameters in mice [ 30 ]. In the current study, aqueous extracts of mulberry leaves administered orally at doses of 1,000, 2,000 and 4,000 mg/kg bw did not induce any significant alterations in bw/weight gain, food consumption, ophthalmoscopy, clinical pathology, gross pathology, organ weights or histopathology over 28 days [ 31 ]. Our findings for EMfCs were differenced from those observed upon investigation of the cell viability of 3T3-L1 adipocytes treated with 100 µg/mL of ethanol extract of mulberry leaves, because the samples were prepared using different methods and treated with different dosage.…”

Section: Discussionmentioning

confidence: 99%

Lipolytic effect of novel extracts from mulberry (Morus alba) leaves fermented withCordyceps militarisin the primary adipocytes derived from SD rats

et al. 2017

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Mulberry (Morus alba) leaves are known to have therapeutic effects on lipid metabolism including lipogenesis, lipolysis and hyperlipidemia. However, novel compounds with strong lipolytic ability among 27 extracts of the mulberry leaves fermented with Cordyceps militaris (EMfCs) have not yet been identified. Therefore, the cAMP concentration and cell viability were measured in the primary adipocytes of SD (Sprague Dawley) rats and 3T3-L1 cells after treatment of 27 EMfCs. Briefly, mulberry leaves powders amended with three different concentrations (0, 25 and 50%) of silkworm pupae (SWP) powder were fermented with 10% C. militaris (v/w) during three different periods (3, 4 and 6 weeks). A total of 27 extracts were obtained from the fermented mulberry leaves powders using three different solvents (dH2O, 50% EtOH and 95% EtOH). Among the 27 EMfCs treated groups, a significant increase in the concentration of cAMP was detected in primary adipocytes treated with 10 extracts when compared with the Vehicle treated group. However, their cAMP concentration did not agree completely with the non-toxicity, although most extracts showed non-toxicity. Furthermore, the concentration of cAMP and level of free glycerol gradually increased in a dose dependent manner (100, 200 and 400 µg/mL) of 4M3-95 contained cordycepin without any significant toxicity. Overall, the results of this study provide strong evidence that 4M3-95 extract derived from EMfCs can stimulate the lipolysis of primary adipocytes at an appropriate concentration and therefore have the potential for use as lipolytic agents to treat obesity.

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A 28-Day Repeated Dose Toxicological Study of an Aqueous Extract of Morus Alba L.

Cited by 25 publications

References 31 publications

Safety assessment of a standardized cucumber extract (Q-Actin™): Oral repeat-dose toxicity and mutagenicity studies

Safety assessment of a standardized cucumber extract (Q-Actin™): Oral repeat-dose toxicity and mutagenicity studies

A Synergistic Formulation of Plant Extracts Decreases Postprandial Glucose and Insulin Peaks: Results from Two Randomized, Controlled, Cross-Over Studies Using Real-World Meals

Lipolytic effect of novel extracts from mulberry (Morus alba) leaves fermented withCordyceps militarisin the primary adipocytes derived from SD rats

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