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

Abstract

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 .

Effects of coenzyme Q10 supplementation on glycemic control: A GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials

“…Overall, a total of 3697 studies were retrieved from a search of databases, and after title and abstract screening, 2701 were excluded. Evaluation of 81 full-text reports resulted in identification of 40 randomized controlled trials articles 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 that could be included in the analysis. Reasons for exclusion included duration <2 weeks ( n = 16), inappropriate placebo in control group ( n = 10), intervention included CoQ10 and other factors ( n = 12), and article cannot be obtained ( n = 3).…”

Effects of coenzyme Q10 supplementation on glycemic control: A GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials

“…Overall, a total of 3697 studies were retrieved from a search of databases, and after title and abstract screening, 2701 were excluded. Evaluation of 81 full-text reports resulted in identification of 40 randomized controlled trials articles 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 that could be included in the analysis. Reasons for exclusion included duration <2 weeks ( n = 16), inappropriate placebo in control group ( n = 10), intervention included CoQ10 and other factors ( n = 12), and article cannot be obtained ( n = 3).…”

Associations between Long-Term Dietary Coenzyme Q10 Intake and New-Onset Hypertension in Adults: Insights from a Nationwide Prospective Cohort Study

“…Although the findings are not yet consistent, they suggest a potential link between them. Two intervention studies conducted in healthy population indicated that high doses of CoQ10 (900 mg/day) over a duration of 4 weeks did not have a significant impact on BP [21,22]. While focusing on the cardiometabolic diseases population, our recent dose-response meta-analysis of twenty-six RCTs with durations ranging from 1 to 24 months showed that CoQ10 supplementation significantly decreased SBP (WMD: −4.77 mmHg; 95% CI: −6.57 to −2.97) with a clinically optimal dose of 100-200 mg/day [10].…”

Emulsification of Coenzyme Q₁₀ Using Gum Arabic Increases Bioavailability in Rats and Human and Improves Food-Processing Suitability

“…Because of its lipophilia, CoQ 10 is poorly absorbed in humans when taken orally, especially under fasting conditions ( 15 , 16 ). Therefore, various methods of emulsification with modified food starch ( 17 ), lecithin ( 18 ), gum arabic ( 19 ), or polysorbate 80 ( 18 , 20 ), or inclusion of ␥ -cyclodextrin ( 15 ), have been used to decrease the hydrophobicity of CoQ 10 . The strategy of emulsification of drugs to decrease hydrophobicity and boost bioavailability has already been used and reported ( 21 , 22 ).…”

Effects of coenzyme Q10 supplementation on glycemic control: A GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials

“…Overall, a total of 3697 studies were retrieved from a search of databases, and after title and abstract screening, 2701 were excluded. Evaluation of 81 full-text reports resulted in identification of 40 randomized controlled trials articles 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 that could be included in the analysis. Reasons for exclusion included duration <2 weeks ( n = 16), inappropriate placebo in control group ( n = 10), intervention included CoQ10 and other factors ( n = 12), and article cannot be obtained ( n = 3).…”

Associations between Long-Term Dietary Coenzyme Q10 Intake and New-Onset Hypertension in Adults: Insights from a Nationwide Prospective Cohort Study

“…Although the findings are not yet consistent, they suggest a potential link between them. Two intervention studies conducted in healthy population indicated that high doses of CoQ10 (900 mg/day) over a duration of 4 weeks did not have a significant impact on BP [21,22]. While focusing on the cardiometabolic diseases population, our recent dose-response meta-analysis of twenty-six RCTs with durations ranging from 1 to 24 months showed that CoQ10 supplementation significantly decreased SBP (WMD: −4.77 mmHg; 95% CI: −6.57 to −2.97) with a clinically optimal dose of 100-200 mg/day [10].…”

Emulsification of Coenzyme Q₁₀ Using Gum Arabic Increases Bioavailability in Rats and Human and Improves Food-Processing Suitability

“…Because of its lipophilia, CoQ 10 is poorly absorbed in humans when taken orally, especially under fasting conditions ( 15 , 16 ). Therefore, various methods of emulsification with modified food starch ( 17 ), lecithin ( 18 ), gum arabic ( 19 ), or polysorbate 80 ( 18 , 20 ), or inclusion of ␥ -cyclodextrin ( 15 ), have been used to decrease the hydrophobicity of CoQ 10 . The strategy of emulsification of drugs to decrease hydrophobicity and boost bioavailability has already been used and reported ( 21 , 22 ).…”

Effects of coenzyme Q10 supplementation on glycemic control: A GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials

“…Overall, a total of 3697 studies were retrieved from a search of databases, and after title and abstract screening, 2701 were excluded. Evaluation of 81 full-text reports resulted in identification of 40 randomized controlled trials articles 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 that could be included in the analysis. Reasons for exclusion included duration <2 weeks ( n = 16), inappropriate placebo in control group ( n = 10), intervention included CoQ10 and other factors ( n = 12), and article cannot be obtained ( n = 3).…”

Associations between Long-Term Dietary Coenzyme Q10 Intake and New-Onset Hypertension in Adults: Insights from a Nationwide Prospective Cohort Study

“…Although the findings are not yet consistent, they suggest a potential link between them. Two intervention studies conducted in healthy population indicated that high doses of CoQ10 (900 mg/day) over a duration of 4 weeks did not have a significant impact on BP [21,22]. While focusing on the cardiometabolic diseases population, our recent dose-response meta-analysis of twenty-six RCTs with durations ranging from 1 to 24 months showed that CoQ10 supplementation significantly decreased SBP (WMD: −4.77 mmHg; 95% CI: −6.57 to −2.97) with a clinically optimal dose of 100-200 mg/day [10].…”

Emulsification of Coenzyme Q₁₀ Using Gum Arabic Increases Bioavailability in Rats and Human and Improves Food-Processing Suitability

“…Because of its lipophilia, CoQ 10 is poorly absorbed in humans when taken orally, especially under fasting conditions ( 15 , 16 ). Therefore, various methods of emulsification with modified food starch ( 17 ), lecithin ( 18 ), gum arabic ( 19 ), or polysorbate 80 ( 18 , 20 ), or inclusion of ␥ -cyclodextrin ( 15 ), have been used to decrease the hydrophobicity of CoQ 10 . The strategy of emulsification of drugs to decrease hydrophobicity and boost bioavailability has already been used and reported ( 21 , 22 ).…”