A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum
This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of <i>Chrysanthemum indicum</i> Linn flower extract and <i>Cinnamomum cassia</i> extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a ra...
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MDPI AG
2020-12-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/12/12/3794 |
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| author | Yu Hwa Park Do Hoon Kim Jung Suk Lee Hyun Il Jeong Kye Wan Lee Tong Ho Kang |
| author_facet | Yu Hwa Park Do Hoon Kim Jung Suk Lee Hyun Il Jeong Kye Wan Lee Tong Ho Kang |
| author_sort | Yu Hwa Park |
| collection | DOAJ |
| description | This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of <i>Chrysanthemum indicum</i> Linn flower extract and <i>Cinnamomum cassia</i> extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (<i>p</i> = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (<i>p</i> = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (<i>p</i> = 0.0324), a statistically significant difference (<i>p</i> = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (<i>p</i> = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (<i>p</i> = 0.2187), a statistically significant difference between the administration groups (<i>p</i> = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840. |
| first_indexed | 2024-03-10T14:09:34Z |
| format | Article |
| id | doaj.art-34297e7555ad4f4ea47e92e0e99914ea |
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| language | English |
| last_indexed | 2024-03-10T14:09:34Z |
| publishDate | 2020-12-01 |
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| series | Nutrients |
| spelling | doaj.art-34297e7555ad4f4ea47e92e0e99914ea2023-11-21T00:17:12ZengMDPI AGNutrients2072-66432020-12-011212379410.3390/nu12123794A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in SerumYu Hwa Park0Do Hoon Kim1Jung Suk Lee2Hyun Il Jeong3Kye Wan Lee4Tong Ho Kang5Department of Oriental Medicine Biotechnology, Global Campus, Graduate School of Biotechnology and College of Life Sciences, Kyung Hee University, Gyeonggi 17104, KoreaDepartment of Oriental Medicine Biotechnology, Global Campus, Graduate School of Biotechnology and College of Life Sciences, Kyung Hee University, Gyeonggi 17104, KoreaR&D Center, Dongkook Pharm. Co., Ltd., Gyeonggi 16229, KoreaR&D Center, Dongkook Pharm. Co., Ltd., Gyeonggi 16229, KoreaR&D Center, Dongkook Pharm. Co., Ltd., Gyeonggi 16229, KoreaDepartment of Oriental Medicine Biotechnology, Global Campus, Graduate School of Biotechnology and College of Life Sciences, Kyung Hee University, Gyeonggi 17104, KoreaThis study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of <i>Chrysanthemum indicum</i> Linn flower extract and <i>Cinnamomum cassia</i> extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (<i>p</i> = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (<i>p</i> = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (<i>p</i> = 0.0324), a statistically significant difference (<i>p</i> = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (<i>p</i> = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (<i>p</i> = 0.2187), a statistically significant difference between the administration groups (<i>p</i> = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.https://www.mdpi.com/2072-6643/12/12/3794dietary supplementsasymptomatic hyperuricemiaDKB114<i>Chrysanthemum indicum</i> Linn<i>Cinnamomum cassia</i>clinical trial |
| spellingShingle | Yu Hwa Park Do Hoon Kim Jung Suk Lee Hyun Il Jeong Kye Wan Lee Tong Ho Kang A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum Nutrients dietary supplements asymptomatic hyperuricemia DKB114 <i>Chrysanthemum indicum</i> Linn <i>Cinnamomum cassia</i> clinical trial |
| title | A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum |
| title_full | A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum |
| title_fullStr | A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum |
| title_full_unstemmed | A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum |
| title_short | A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum |
| title_sort | 12 week multicenter randomized double blind placebo controlled clinical trial for evaluation of the efficacy and safety of dkb114 on reduction of uric acid in serum |
| topic | dietary supplements asymptomatic hyperuricemia DKB114 <i>Chrysanthemum indicum</i> Linn <i>Cinnamomum cassia</i> clinical trial |
| url | https://www.mdpi.com/2072-6643/12/12/3794 |
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