One year oral toxicity of D-004, a lipid extract from Roystonea regia fruits, in Sprague–Dawley rats

Gámez, Rafael; Gutiérrez, Ariadne; Arencibia, Daniel Francisco; Pardo, Balia; Noa, Miríam; R, Más; Valle, Maikel; Oyarzábal, Ambar; Curveco, Dayisell; Garcı́a, Hilda; Goicochea, Eddy; Mendoza, Nilda; Jiménez, Sònia

doi:10.1016/j.toxlet.2010.03.894

Cited by 4 publications

(10 citation statements)

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“…Individual values of tested surrogates were within those reported for such species (Wolford et al, 1986;Alemán et al, 2000;Matsuzawa, Nomura, and Unno T, 1993), and the results consistent with those of the previous study of the oral subchronic toxicity of D-004 in the rat (Gámez et al, 2005). D-004, administered orally from 200 to 800 mg/kg for only 14 days, has shown to prevent PH induced with T in rats and mice Carbajal et al, 2004Carbajal et al, , 2005Noa et al, 2005), and rats supplemented with (3H)-labelled-oleic acid mixed in D-004 at 400 mg/kg showed a fast and broad radioactivity tissue distribution as soon as two hours after dosing, highest in the prostate compared with other tissues and plasma (Pérez et al, 2006c), consistent with the efficacy of D-004.…”

Section: Discussionsupporting

confidence: 90%

“…D-004, administered orally from 200 to 800 mg/kg for only 14 days, has shown to prevent PH induced with T in rats and mice Carbajal et al, 2004Carbajal et al, , 2005Noa et al, 2005), and rats supplemented with (3H)-labelled-oleic acid mixed in D-004 at 400 mg/kg showed a fast and broad radioactivity tissue distribution as soon as two hours after dosing, highest in the prostate compared with other tissues and plasma (Pérez et al, 2006c), consistent with the efficacy of D-004. Thus, the lack of toxicity found in the present study should not be attributable to an inadequate treatment exposure (Gámez et al, 2005).…”

Section: Discussionmentioning

confidence: 49%

“…The same was noted in a previous subchronic study in rats treated with doses up to 2000 mg/kg for 90 days (Gámez et al, 2005). Considering that the toxicity of a new substance should be assessed in two rodent species, the aim of this study was to investigate the oral subchronic toxicity of D-004 in NMRI mice.…”

Section: Introductionmentioning

confidence: 65%

“…This lesion has no link with the observed reductions of the liver, kidneys, and spleen weights of treated male, a finding without conclusive explanation to date. The weight findings could be a random result, since the previous study of the oral subchronic study of D-004 in rats did not find any change in the relative weight of such organs (Gámez et al, 2005). Further long-term studies of oral toxicity of D-004 should be followed carefully to see if similar results are obtained after longer treatment with D-004.…”

Section: D-004 Subchronic Oral Toxicity In Mice 225mentioning

confidence: 93%

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Oral Subchronic Toxicity of a Lipid Extract fromRoystonea regiaFruits in Mice

Gutiérrez

Gámez

Más

et al. 2008

Drug and Chemical Toxicology

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D-004 is a lipid extract of royal palm (Rosytonea regia) fruits that prevents prostate hyperplasia induced with testosterone in rodents. Previous studies have shown no D-004-related toxicity in rats, but no study in mice had been reported. D-004 (500, 1000, and 2000 mg/kg) was evaluated in a subchronic (eight weeks) study in NMRI mice. No evidences of treatment-related toxicity were detected. Thus, body-weight gain, clinical observations, food consumption, blood biochemical, hematology, organ-weight ratios, and histopathological findings were similar in control and treated groups. This study supports that D-004 orally administered up to 2000 mg/kg did not induce treatment-related toxicity.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 49%

Section: Introductionmentioning

confidence: 65%

Section: D-004 Subchronic Oral Toxicity In Mice 225mentioning

confidence: 93%

See 2 more Smart Citations

Oral Subchronic Toxicity of a Lipid Extract fromRoystonea regiaFruits in Mice

Gutiérrez

Gámez

Más

et al. 2008

Drug and Chemical Toxicology

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“…Protective effects of Roystonea regia fruit lipid extracts on prostatic hyperplasia were tested in Cuban National Centre for Scientific Research (Arruzazabala et al, 2004(Arruzazabala et al, , 2005Gamez et al, 2005). Euterpe oleracea used by the Matowai, Arawak and Warao indigenous people for many ailments, hold promise in modern medicine as an alternative oral contrast agent in MRI of the gastrointestinal system (Cordova-Fraga et al, 2004).…”

Section: Medicinal Palms Of Americasmentioning

confidence: 99%

American palms used for medicine, in the ethnobotanical and pharmacological publications

Sosnowska

Balslev

2008

Rev peru biol

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The center of diversity of palms (Arecaceae) in tropical America is found in the Amazon basin and along the Panamanian isthmus.The greatest palm species richness has been reported for the Iquitos and Chocó areas. Many species of palms are used mainly for construction and due to their edible fruits. In addition, there are 104 palm species that are used for medicinal purposes in many regions of the Americas. Cocos nuciferaand Oenocarpus batauaare the most commonly used species for medicinal purposes. The fruit is the most commonly used part of palms for medicinal purposes (57 species). The traditional and medicinal use of plants has deep roots in indigenous communities of Latin America. The significance of ethnomedicine for health care of local populations can not be ignored anymore because it plays a significant role in basic health care in developing countries. Interdisciplinary research in antropology, ethnobotany and ethnopharmacology helps gather information on ethnomedicine and design new drugs for modern medicine. American palms are sources of useful bioactive compounds against diabetes, prostate hyperplasia and leishmaniasis.

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Antioxidant effects of D-004, a lipid extract from the Roystonea regia fruit, on the plasma of healthy men

López¹,

Molina²,

Illnait³

et al. 2009

Asian J Androl

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The aim of this study was to conduct a randomized, double-blind and placebo-controlled study to investigate the effects of D-004, a lipid extract of the Roystonea regia fruit that prevents testosterone- and phenylepinephrine-induced prostate hyperplasia in rodents, on plasma oxidative markers in healthy men. We enrolled male volunteers (20-55 years) in good health and without lower urinary tract symptoms. Thirty-four eligible participants were randomized to placebo or D-004 (320 mg) capsules administered daily for 6 weeks. An interim check-up and a final visit were conducted after 3 and 6 weeks of therapy, respectively. Physical examinations were performed at each visit, and laboratory tests were performed at baseline and at treatment completion. Oxidative variables included plasma malondialdehyde (MDA), total hydroxyperoxides (TOH), sulphydryl (SH) groups and total antioxidant status (TAS). We assessed treatment compliance and addressed adverse experiences (AEs) at weeks 3 and 6. At week 6, with D-004, the mean reductions of plasma MDA (26.7%), TOH (18.8%) and SH groups (31.6%), and the mean increase of TAS (35.3%) were significantly different from those of placebo (P<0.001 for plasma TAS, P<0.0001 for all other comparisons). D-004 did not differ from the placebo in safety indicators. There were two withdrawals (both in the D-004 group), with one due to dyspepsia (the only AE during the trial). In conclusion, D-004 displayed antioxidant effects on plasma oxidative markers in healthy men, which was consistent with findings from laboratory experimental studies.

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One year oral toxicity of D-004, a lipid extract from Roystonea regia fruits, in Sprague–Dawley rats

Cited by 4 publications

References 0 publications

Oral Subchronic Toxicity of a Lipid Extract fromRoystonea regiaFruits in Mice

Oral Subchronic Toxicity of a Lipid Extract fromRoystonea regiaFruits in Mice

American palms used for medicine, in the ethnobotanical and pharmacological publications

Antioxidant effects of D-004, a lipid extract from the Roystonea regia fruit, on the plasma of healthy men

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