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 Linn flower extract and 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 subje...

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Veröffentlicht in:Nutrients 2020-12, Vol.12 (12), p.3794
Hauptverfasser: Park, Yu Hwa, Kim, Do Hoon, Lee, Jung Suk, Jeong, Hyun Il, Lee, Kye Wan, Kang, Tong Ho
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Kim, Do Hoon
Lee, Jung Suk
Jeong, Hyun Il
Lee, Kye Wan
Kang, Tong Ho
description This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Linn flower extract and 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 ( = 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 ( = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL ( = 0.0324), a statistically significant difference ( = 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 ( = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL ( = 0.2187), a statistically significant difference between the administration groups ( = 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.
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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 ( = 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 ( = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL ( = 0.0324), a statistically significant difference ( = 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 ( = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL ( = 0.2187), a statistically significant difference between the administration groups ( = 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.</description><identifier>ISSN: 2072-6643</identifier><identifier>EISSN: 2072-6643</identifier><identifier>DOI: 10.3390/nu12123794</identifier><identifier>PMID: 33322063</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Adult ; Arthritis ; Asymptomatic ; Blood pressure ; C-reactive protein ; C-Reactive Protein - drug effects ; Cardiovascular disease ; Cellulose ; Chrysanthemum ; Cinnamomum aromaticum ; Clinical trials ; Complex Mixtures ; Consent ; Diabetes ; Diet ; Dietary Supplements ; Double-Blind Method ; Double-blind studies ; Drug dosages ; Drug withdrawal ; EKG ; Electrocardiography ; Evaluation ; Exercise ; Fatty acids ; Female ; Food Ingredients - analysis ; Gout ; Hospitals ; Humans ; Hypertension ; Hyperuricemia ; Hyperuricemia - blood ; Hyperuricemia - therapy ; Ingestion ; Male ; Medicine ; Metabolism ; Middle Aged ; Physical fitness ; Plant Extracts - administration &amp; dosage ; Review boards ; Rheumatism ; Safety ; Silica ; Statistical analysis ; Treatment Outcome ; Uric acid ; Uric Acid - blood</subject><ispartof>Nutrients, 2020-12, Vol.12 (12), p.3794</ispartof><rights>2020. 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Kr): KCT0002840.</description><subject>Adult</subject><subject>Arthritis</subject><subject>Asymptomatic</subject><subject>Blood pressure</subject><subject>C-reactive protein</subject><subject>C-Reactive Protein - drug effects</subject><subject>Cardiovascular disease</subject><subject>Cellulose</subject><subject>Chrysanthemum</subject><subject>Cinnamomum aromaticum</subject><subject>Clinical trials</subject><subject>Complex Mixtures</subject><subject>Consent</subject><subject>Diabetes</subject><subject>Diet</subject><subject>Dietary Supplements</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug dosages</subject><subject>Drug withdrawal</subject><subject>EKG</subject><subject>Electrocardiography</subject><subject>Evaluation</subject><subject>Exercise</subject><subject>Fatty acids</subject><subject>Female</subject><subject>Food Ingredients - analysis</subject><subject>Gout</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Hyperuricemia</subject><subject>Hyperuricemia - blood</subject><subject>Hyperuricemia - therapy</subject><subject>Ingestion</subject><subject>Male</subject><subject>Medicine</subject><subject>Metabolism</subject><subject>Middle Aged</subject><subject>Physical fitness</subject><subject>Plant Extracts - administration &amp; dosage</subject><subject>Review boards</subject><subject>Rheumatism</subject><subject>Safety</subject><subject>Silica</subject><subject>Statistical analysis</subject><subject>Treatment Outcome</subject><subject>Uric acid</subject><subject>Uric Acid - blood</subject><issn>2072-6643</issn><issn>2072-6643</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNpdkttu1DAQhiMEolXpDQ-ALHGD0Kb4FJvcIG23C0UUgdpFXEaz9oS6OHZx4krLI_GUeOmBgi980P_Nr5nxVNVTRg-EaOmrkBlnXOhWPqh2OdW8VkqKh_fuO9X-OF7Q7dJUK_G42hFCcE6V2K1-zQnj9VfE7zPyMfvJGQwTphk5hWDj4H6inZGjmNce60PvQnl99mBwHetFDFOK3qMli6I4A56skit7HxNZXoHPMLkYSOzJdI5k2feFMRtSnMkZ9DhtttLRh0PGJCncKdpsbiO-JGfI3DhLXCBnmPLwpHrUgx9x_-bcq1Zvl6vFcX3y6d37xfykNpKqqca2FVpbKRtjGVeATfuaI8VWMaCtgEZZAItUAHDsNTWSacZhvW6kElqIverNte1lXg9ot_1I4LvL5AZImy6C6_5VgjvvvsWrTpfeqj8GL24MUvyRcZy6wY0GvYeAMY8dl5oqLmmjCvr8P_Qi5hRKdYVSpRDeNk2hXl5TJsVxTNjfJcNotx2C7u8QFPjZ_fTv0NsvF78BJZmrow</recordid><startdate>20201210</startdate><enddate>20201210</enddate><creator>Park, Yu Hwa</creator><creator>Kim, Do Hoon</creator><creator>Lee, Jung Suk</creator><creator>Jeong, Hyun Il</creator><creator>Lee, Kye Wan</creator><creator>Kang, Tong Ho</creator><general>MDPI AG</general><general>MDPI</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7487-8973</orcidid><orcidid>https://orcid.org/0000-0002-8076-1349</orcidid><orcidid>https://orcid.org/0000-0002-4161-6798</orcidid></search><sort><creationdate>20201210</creationdate><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><author>Park, Yu Hwa ; 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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 ( = 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 ( = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL ( = 0.0324), a statistically significant difference ( = 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 ( = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL ( = 0.2187), a statistically significant difference between the administration groups ( = 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.</abstract><cop>Switzerland</cop><pub>MDPI AG</pub><pmid>33322063</pmid><doi>10.3390/nu12123794</doi><orcidid>https://orcid.org/0000-0001-7487-8973</orcidid><orcidid>https://orcid.org/0000-0002-8076-1349</orcidid><orcidid>https://orcid.org/0000-0002-4161-6798</orcidid><oa>free_for_read</oa></addata></record>
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subjects Adult
Arthritis
Asymptomatic
Blood pressure
C-reactive protein
C-Reactive Protein - drug effects
Cardiovascular disease
Cellulose
Chrysanthemum
Cinnamomum aromaticum
Clinical trials
Complex Mixtures
Consent
Diabetes
Diet
Dietary Supplements
Double-Blind Method
Double-blind studies
Drug dosages
Drug withdrawal
EKG
Electrocardiography
Evaluation
Exercise
Fatty acids
Female
Food Ingredients - analysis
Gout
Hospitals
Humans
Hypertension
Hyperuricemia
Hyperuricemia - blood
Hyperuricemia - therapy
Ingestion
Male
Medicine
Metabolism
Middle Aged
Physical fitness
Plant Extracts - administration & dosage
Review boards
Rheumatism
Safety
Silica
Statistical analysis
Treatment Outcome
Uric acid
Uric Acid - blood
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
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