A 91-d Repeated Dose Oral Toxicity Study of PureSorb-Q 40 in Rats

Nukui, Kazuki; Tsuneo, Koike; Yamagishi, Toshihiko; Ihota, Hiromi; Nagase, Takahiko; Kimura, Hiroyuki; Satô, Kiyoshi

doi:10.3177/jnsv.53.306

Cited by 3 publications

(1 citation statement)

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“…A 13-wk consecutive P40 dosing study using rats (sub-acute toxicity study) showed that the nontoxic dosage of P40 in both male and female rats was 2,000 mg/kg, confirming that P40 is a highly safe food material ( 8 ). A study of single oral intake using rats and humans has shown that, compared to lipid-soluble CoQ 10 , uptake rate and volume of CoQ 10 are significantly higher for P40 when administered both postprandially and in the fasting state ( 9 ).…”

Section: Toxicity Clinical Trialmentioning

confidence: 89%

Safety Assessment of PureSorb-QTM40 in Healthy Subjects and Serum Coenzyme Q10 Level in Excessive Dosing

Nukui

Matsuoka

Yamagishi

et al. 2007

J Nutr Sci Vitaminol

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Summary PureSorb-Q TM 40 (water-soluble type CoQ 10 powder, CoQ 10 content is 40 w/ w%; hereinafter referred to as P40) is reported in the single-dose human and rat studies to have a greater absorption rate and absorbed volume of CoQ 10 even taken postprandially, than those of regular CoQ 10 , which is lipid-soluble and generally taken in the form of soft-gel capsules. Thus, it was anticipated that the serum CoQ 10 level might be higher with P40 tablets than with soft-gel capsules, even for the same dose of CoQ 10 . In the present study, in order to confirm the safety and measure the serum CoQ 10 level for the case of an excessive dose of P40, a double-blinded Placebo controlled comparative study was conducted on 46 healthy volunteers and they were randomly divided into two groups. The P40 tablets or placebo were repeatedly taken by the volunteers. As the result of the study, for the group of taking 2,250 mg/d of P40 (that is, 900 mg/d of CoQ 10 ) for 4 consecutive wk, the serum CoQ 10 level peaked at 2 wk after the start of intake at 8.79 Ϯ 3.34 g/mL, and at 4 wk, it was at the level of 8.33 Ϯ 4.04 g/mL. At 2 wk from withdrawal of intake, the serum CoQ 10 level decreased to 1.30 Ϯ 0.49 g/mL. The serum CoQ 10 levels at these three points were significantly higher than those of the first day of intake and the Placebo group, which had no significant change throughout the study. Furthermore, P40 intake did not cause any significant changes in symptoms or clinical laboratory results as assessed by physical, hematological, blood biochemical or urinalysis tests. Physician examinations also did not reveal any abnormalities. These results confirm that P40 is an extremely safe material and it can produce better absorption of CoQ 10 .

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Section: Toxicity Clinical Trialmentioning

confidence: 89%

Safety Assessment of PureSorb-QTM40 in Healthy Subjects and Serum Coenzyme Q10 Level in Excessive Dosing

Nukui

Matsuoka

Yamagishi

et al. 2007

J Nutr Sci Vitaminol

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Safety assessment of coenzyme Q₁₀ (CoQ₁₀)

et al. 2008

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Coenzyme Q10 (CoQ10) is a naturally occurring component present in living cells. Its physiological function is to act as an essential cofactor for ATP production, and to perform important antioxidant activities in the body. In most countries, CoQ10 has been widely used as a dietary supplement for more than 20 years. Recently, the use of CoQ10 as a dietary supplement has grown with a corresponding increase in daily dosage. The present review describes the safety profile of CoQ10 on the basis of animal and human data. The published reports concerning safety studies indicate that CoQ10 has low toxicity and does not induce serious adverse effects in humans. The acceptable daily intake (ADI) is 12mg/kg/day, calculated from the no-observed-adverse-effect level (NOAEL) of 1200 mg/kg/day derived from a 52-week chronic toxicity study in rats, i.e., 720 mg/day for a person weighing 60 kg. Risk assessment for CoQ10 based on various clinical trial data indicates that the observed safety level (OSL) for CoQ10 is 1200 mg/day/person. Evidence from pharmacokinetic studies suggest that exogenous CoQ10 does not influence the biosynthesis of endogenous CoQ9/CoQ10 nor does it accumulate into plasma or tissues after cessation of supplementation. Overall, these data from preclinical and clinical studies indicate that CoQ10 is highly safe for use as a dietary supplement. Additionally, analysis of CoQ10 bioavailability or its pharmacokinetics provides the pertinent safety evaluation for CoQ10.

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Blood CoQ₁₀ levels and safety profile after singe‐dose or chronic administration of PureSorb‐Q™40: Animal and human studies

Nukui¹,

Yamagishi²,

Miyawaki³

et al. 2008

BioFactors

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Coenzyme Q10 (CoQ10) is known to be highly hydrophobic and, as such, insoluble in water: this leads to serious inconvenience when trying to incorporate it in food products. Its absorption is also known to be very limited. PureSorb-Q40 (P40) (Water-soluble type CoQ10 powder, CoQ10 content 40 w/w % was developed in order to improve its use with food products and to enhance its absorption. In the present study the absorption of this novel formulation was compared to a conventional lipid soluble CoQ10 by administering both products to rats and humans. Acute, single-administration studies in rats showed that P40 has a higher absorption, compared to lipid soluble CoQ10, both in prandial and fasting states. Similarly, single administration in humans revealed a higher absorption level for P40, taken in the fasting state or together with meals. In the rat study, no adverse effects were observed with P40 at doses up to 2,000 mg/kg in both sexes. In a double-blind, placebo controlled, comparative study conducted on 46 healthy volunteers and randomly divided into two groups, in the group receiving 900~mg of CoQ10 per day, for 4 consecutive weeks, the average level at two weeks was 8.79 +/- 3.34 microg/mL, similar to the corresponding level after 4 weeks (8.33 +/- 4.04 microg/mL). After 2 weeks of washout, serum CoQ10 level decreased to 1.30 +/- 0.49 microg/mL. P40 intake did not cause any significant changes in symptoms and clinical laboratory tests as assessed by physical, hematological, blood biochemical or urinalysis. Clinical examinations also did not reveal any abnormalities. The above blood (serum) CoQ10 level at 2 weeks after start of intake was compared with other reported values. The same dose of CoQ10 (900mg/day), when administered by softgel capsules yielded a plasma CoQ10 concentration of 3.6 microg/mL, while P40 levels were 8.79 +/- 3.34 microg/mL. These levels are remarkably high for instance when compared to the corresponding levels obtained, in patients affected by Parkinson's disease, with CoQ10 doses up to 2,400mg/day. A clinical study was conducted using doses of 300 mg/day and 600 mg/day, in patients affected by cardiovascular disease. Also in this case there was linearity in the response with the levels obtained by administering P40 at a dose of 100 and 900 mg/day.

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A 91-d Repeated Dose Oral Toxicity Study of PureSorb-Q 40 in Rats

Cited by 3 publications

References 11 publications

Safety Assessment of PureSorb-QTM40 in Healthy Subjects and Serum Coenzyme Q10 Level in Excessive Dosing

Safety Assessment of PureSorb-QTM40 in Healthy Subjects and Serum Coenzyme Q10 Level in Excessive Dosing

Safety assessment of coenzyme Q₁₀ (CoQ₁₀)

Blood CoQ₁₀ levels and safety profile after singe‐dose or chronic administration of PureSorb‐Q™40: Animal and human studies

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A 91-d Repeated Dose Oral Toxicity Study of PureSorb-Q 40 in Rats

Cited by 3 publications

References 11 publications

Safety Assessment of PureSorb-QTM40 in Healthy Subjects and Serum Coenzyme Q10 Level in Excessive Dosing

Safety Assessment of PureSorb-QTM40 in Healthy Subjects and Serum Coenzyme Q10 Level in Excessive Dosing

Safety assessment of coenzyme Q10 (CoQ10)

Blood CoQ10 levels and safety profile after singe‐dose or chronic administration of PureSorb‐Q™40: Animal and human studies

Contact Info

Product

Resources

About

Safety assessment of coenzyme Q₁₀ (CoQ₁₀)

Blood CoQ₁₀ levels and safety profile after singe‐dose or chronic administration of PureSorb‐Q™40: Animal and human studies