Toxicity Studies of Blockal, a Dietary Supplement Containing Phase 2 Starch Neutralizer (Phase 2), a Standardized Extract of the Common White Kidney Bean (Phaseolus vulgaris)

2006 ◽  
Vol 25 (5) ◽  
pp. 361-371 ◽  
Author(s):  
Dilip Chokshi
Keyword(s):  
Phaseolus Vulgaris ◽  
Dietary Supplement ◽  
Digestive Enzyme ◽  
Kidney Bean ◽  
Phase 2 ◽  
Main Ingredient ◽  
Oral Toxicity ◽  
Toxicity Studies ◽  
Effect Level ◽  
The Common

The number of available dietary supplements containing “starch blockers” intended for weight loss has risen dramatically in recent years. These supplements are believed to reduce carbohydrate-derived calories by interfering with α-amylase, the digestive enzyme responsible for conversion of complex carbohydrates to simple absorbable sugars. The present paper reports the findings of single- and multiple-dose (4-week) oral toxicity studies in rats of the marketed dietary supplement Blockal. Blockal contains as its main ingredient Phase 2 Starch Neutralizer (Phase 2 or Phaseolamin 2250), a standardized extract derived from the common white kidney bean ( Phaseolus vulgaris) that has been shown to have α-amylase-inhibiting activity. The Blockal acute oral LD50 exceeded the highest dose tested (3 g/kg body weight [bw]), which provided a single dose of 1668 mg/kg bw of Phase 2 white kidney bean extract. The no-observed-effect level (NOEL) seen in the 4-week study was equivalent to the highest Blockal dose tested (2 g/kg bw/day), which provided 1112 mg/kg/day of Phase 2 white kidney bean extract. The results of these studies support and are consistent with the safety of the marketed dietary supplement Blockal, and indirectly, the safety of its main ingredient, Phase 2 Starch Neutralizer (Phase 2 or Phaseolamin 2250), a standardized extract derived from the common white kidney bean.

Safety Evaluation of a Proprietary Food-Grade, Dried Fermentate Preparation of Saccharomyces cerevisiae

2012 ◽  
Vol 31 (1) ◽  
pp. 34-45 ◽  
Author(s):  
Alexander G. Schauss ◽  
R. Glavits ◽  
John Endres ◽  
Gitte S. Jensen ◽  
Amy Clewell
Keyword(s):  
Saccharomyces Cerevisiae ◽  
Clinical Symptoms ◽  
Safety Evaluation ◽  
In Vivo Studies ◽  
Oral Toxicity ◽  
Toxicity Studies ◽  
Adverse Effect Level ◽  
Effect Level

A safety evaluation was performed for EpiCor, a product produced by a proprietary fermentation process using Saccharomyces cerevisiae. Studies included the following assays: bacterial reverse mutation, mouse lymphoma cell mutagenicity, mitogenicity assay in human peripheral lymphocytes, and a cytochrome P450 ([CYP] CYP1A2 and CYP3A4) induction assessment as well as 14-day acute, 90-day subchronic, and 1-year chronic oral toxicity studies in rats. No evidence of genotoxicity or mitogenicity was seen in any of the in vitro or in vivo studies. The CYP assessment showed no interactions or inductions. No toxic clinical symptoms or histopathological lesions were observed in the acute, subchronic, or chronic oral toxicity studies in the rat. Results of the studies performed indicate that EpiCor does not possess genotoxic activity and has a low order of toxicity that is well tolerated when administered orally. The no observable adverse effect level (NOAEL) was 1500 mg/kg body weight (bw)/d for the 90-day study and 800 mg/kg bw/d for the 1 year study, for the highest doses tested.

scholarly journals Subchronic Study of a White Kidney Bean (Phaseolus vulgaris) Extract with α-Amylase Inhibitory Activity

2019 ◽  
Vol 2019 ◽  
pp. 1-9 ◽  
Author(s):  
Guangqiu Qin ◽  
Fang Wang ◽  
Huili Liang ◽  
Song Tang ◽  
Kamran Shekh ◽  
...  
Keyword(s):  
Body Weight ◽  
Phaseolus Vulgaris ◽  
Inhibitory Activity ◽  
Toxicity Study ◽  
Kidney Bean ◽  
Female Rats ◽  
Sprague Dawley ◽  
Oral Toxicity ◽  
Experimental Conditions ◽  
Male And Female Rats

Common bean extract as a dietary supplement has received increased attention globally owing to its α-amylase inhibitory activity. The objective of this study was to evaluate the toxicity of a white kidney bean (Phaseolus vulgaris) extract by a repeated-dose 90-day subchronic oral toxicity study in Sprague-Dawley rats. In the subchronic toxicity study, 80 rats were orally administrated with white kidney bean extract at doses of 4, 2, and 1 g/kg body weight daily for 90 days. The results showed that the white kidney bean extract at doses up to 4 g/kg/day did not induce significant changes in body weight, organ weight, food consumption, hematology, serum biochemistry, and histopathology in rats, as compared to the control. The no-observed-adverse-effect level (NOAEL) of white kidney bean extract was determined to be >4 g/kg/day for both male and female rats, under the experimental conditions of this study.

scholarly journals Genetic characterization at the species and symbiovar level of indigenous rhizobial isolates nodulating Phaseolus vulgaris in Greece

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Evdoxia Efstathiadou ◽  
Georgia Ntatsi ◽  
Dimitrios Savvas ◽  
Anastasia P. Tampakaki
Keyword(s):  
Phaseolus Vulgaris ◽  
Common Bean ◽  
Phylogenetic Affiliation ◽  
Rhizobial Inoculation ◽  
Rhizobial Species ◽  
The Common ◽  
First Time ◽  
Of Greece ◽  
Rhizobial Isolates

AbstractPhaseolus vulgaris (L.), commonly known as bean or common bean, is considered a promiscuous legume host since it forms nodules with diverse rhizobial species and symbiovars. Most of the common bean nodulating rhizobia are mainly affiliated to the genus Rhizobium, though strains belonging to Ensifer, Pararhizobium, Mesorhizobium, Bradyrhizobium, and Burkholderia have also been reported. This is the first report on the characterization of bean-nodulating rhizobia at the species and symbiovar level in Greece. The goals of this research were to isolate and characterize rhizobia nodulating local common bean genotypes grown in five different edaphoclimatic regions of Greece with no rhizobial inoculation history. The genetic diversity of the rhizobial isolates was assessed by BOX-PCR and the phylogenetic affiliation was assessed by multilocus sequence analysis (MLSA) of housekeeping and symbiosis-related genes. A total of fifty fast-growing rhizobial strains were isolated and representative isolates with distinct BOX-PCR fingerpriniting patterns were subjected to phylogenetic analysis. The strains were closely related to R. anhuiense, R. azibense, R. hidalgonense, R. sophoriradicis, and to a putative new genospecies which is provisionally named as Rhizobium sp. I. Most strains belonged to symbiovar phaseoli carrying the α-, γ-a and γ-b alleles of nodC gene, while some of them belonged to symbiovar gallicum. To the best of our knowledge, it is the first time that strains assigned to R. sophoriradicis and harbored the γ-b allele were found in European soils. All strains were able to re-nodulate their original host, indicating that they are true microsymbionts of common bean.

Acute and subacute toxicity assessment of Madhulai Manappagu (Siddha herbal syrup formulation) in animal model

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Meenakshi Sundaram Malayappan ◽  
Gayathri Natarajan ◽  
Logamanian Mockaiyathevar ◽  
Meenakumari Ramasamy
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Oral Route ◽  
Toxicity Assessment ◽  
Toxicity Study ◽  
Female Rats ◽  
Albino Rats ◽  
Oral Toxicity ◽  
Gross Pathology ◽  
Toxicity Studies

Abstract Objectives Madhulai Manappagu – a well-known sastric and widely prescribed Siddha herbal syrup formulation indicated for treating Veluppu Noi (Anaemia especially Iron deficiency Anaemia) has been in day today practice in Tamil Nadu for a quite longer decades. The syrup is a herbal preparation which has a sweet pleasant odour and a palatable taste, contain the juice of pomegranate (Punica granatum L.) as the main ingredient. Though the formulation is a fruit juice, the safety profile of the syrup is not established and is being marketed without toxicological evaluation. The study is aimed at ascertaining the acute and sub-acute toxicity assessment of Madhulai Manappagu in Wistar Albino rats. Methods The acute and sub-acute (28day repeated oral) toxicity studies were performed as per the guidelines mentioned in the Organization for Economic Cooperation and Development (OECD) 423 (adopted on December 2001) and TG 407 (adopted on October 2008) with slight modifications respectively. For acute toxicity study, three female rats were randomly selected as control; three female rats were randomly selected and were administered a single dose of 5,000 mg/kg body weight per oral route. For sub-acute (28day repeated oral) toxicity studies, three doses of test drug MM of 500 mg/kg/day (low dose), 750 mg/kg/day (intermittent dose) and 1,000 mg/kg/day (high dose) were selected for administration. Both sexes of Wistar Albino rats were randomized into four groups of 10 animals each (five males, five females). Group I was kept as control group. Group II, III and IV served as low, intermittent and high doses of MM respectively. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed. Results In the acute toxicity study, rats showed no toxicological signs on behavior, gross pathology and body weight of rats when treated with a single dose of 5,000 mg/kg body weight per oral route. In the subacute (28 days repeated oral) toxicity study, rats have showed no significant changes on behavior, gross pathology, body weight, and hematological and biochemical parameters when treated with Madhulai Manappagu in three different doses. Conclusions The toxicity studies which include both acute and 28 days repeated (subacute) oral toxicity studies, revealed no observed adverse effect level (NOAEL) of Madhulai Manappagu in animals. Thus the safety of the drug in human usage was ensured.

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