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

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

doi:10.1016/j.fct.2011.07.061

Cited by 7 publications

(18 citation statements)

References 40 publications

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“…Consistent with earlier experimental toxicological [38][39][40] and clinical [28] data, D-004 was well tolerated and did not produce significant changes in any of the variables studied (including PSA) compared with placebo. Only one paticipant, who voluntarily discontinued the trial, reported an adverse effect (dyspepsia) during the study.…”

Section: Discussionsupporting

confidence: 83%

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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Section: Discussionsupporting

confidence: 83%

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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“…32 Hematocrit and RBC counts in females treated with 1000 mg/kg/d were significantly higher than in the control group, but such significance is not biologically meaningful, since both indicators increased rather than decreased, and all individual values were within normal limits, as reported by other groups 46 and by us. 32 The use of moderate dietary restriction (DR) results in a better controlled rodent model with a lower incidence or delayed onset of spontaneous diseases and tumors. ( Operationally simple, moderate DR significantly improves survival, controls adult body weight, and obesity, reduces agerelated renal, endocrine, and cardiac diseases, increases exposure time, and increases the statistical sensitivity of these expensive, chronic bioassays to detect a true treatment effect.…”

Section: Discussionmentioning

confidence: 43%

“…[30][31][32] In particular, long-term (12 months) oral treatment with D-004 (800-2000 mg/kg/d) did not show evidence of D-004-related toxicity in rats, and the highest dose (2000 mg/kg/d) was a no observable adverse effect level (NOAEL). 32 Genotoxicity studies (Ames test, comet assay, bone marrow micronucleus, Test Substance D-004, obtained from Centre of Natural Products (National Centre for Scientific Research, Havana, Cuba), was used and met control quality specifications. D-004 was obtained through the saponification of royal palm fruits and further extraction and purification in organic solvents.…”

Section: Introductionmentioning

confidence: 97%

Long-Term (24 Months) Carcinogenicity Study of D-004, a Lipid Extract From Roystonea regia Fruits, in Sprague Dawley Rats

et al. 2015

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“…This hypothesis is supported by the fact that no abnormal findings were observed in relation to the administration of the test substance in the remaining rats in the same dose group. We demonstrated that the test substance could be used as a food supplement, because some famous food ingredients were toxic at high doses, (e.g., lemongrass ( Cymbopogon citratus ) essential oil, Roystonea regia fruit, and α -glycerylphosphorylcholine (AGPC)) [ 31 – 33 ]. The results of the serum biochemical examinations of the rat sera revealed reductions in the levels of AST and ALT in the male groups.…”

Section: Discussionmentioning

confidence: 99%

Preclinical Safety of the Root Extract of Polygala tenuifolia Willdenow in Sprague‐Dawley Rats and Beagle Dogs

Shin

Won²,

Ha³

et al. 2014

Evidence-Based Complementary and Alternative Medicine

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The root of Polygala tenuifolia Willdenow has been used for the treatment of insomnia, depression, and amnesia. However, the toxicological properties of the herb have been overlooked, because it has been used for a long time for various purposes. In this study, we evaluated the preclinical safety of the root extract in rats and beagle dogs. First, the acute oral toxicity was tested in both rats and dogs. In the rats, only one female of 2 g/kg died, but no treatment-related death or clinical and gross findings were observed after the administration. No toxicological changes or mortalities related to the test substance were also observed after the administration in the dogs. Although vomiting, discoloration, or hemorrhage was found in some dogs, there were no serious abnormalities. Second, the subchronic toxicity was investigated in the rats. Two animals were found dead in the female group of 1,000 mg/kg/day, but there were no abnormal findings associated with the test substance. There also were no adverse effects on the clinical signs, body weight, and hematological and biochemical findings. Therefore, our results showed that the acute or subchronic toxicity of the root extract of Polygala tenuifolia might not be toxic to rats and dogs.

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

Cited by 7 publications

References 40 publications

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

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

Long-Term (24 Months) Carcinogenicity Study of D-004, a Lipid Extract From Roystonea regia Fruits, in Sprague Dawley Rats

Preclinical Safety of the Root Extract of Polygala tenuifolia Willdenow in Sprague‐Dawley Rats and Beagle Dogs

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