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The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

Primary Purpose

Hyperuricemia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Study Product A (High-dose 2X)
Study Product B (Low-dose X)
Placebo
Sponsored by
Amway (China) R&D Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperuricemia focused on measuring Uric Acid, Amway

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants aged between 18 and 65 years old (mostly above 35 years old), including male and female and the ratio of male to female is not limited; Patients with hyperuricemia: meet the diagnostic criteria set out in the "Chinese Guidelines for Diagnosis and Treatment of Hyperuricemia and Gout (2019)", and fasting blood uric acid level exceeds 420 μmol/L twice on different days. Further classification using the Janssens Gout Diagnostic scale included asymptomatic hyperuricemia (that is, never had a gout attack) and patients with a history of gout, with a ratio of about 1:1; Participants agree not to take any drugs, supplements, or performance enhancers during the study, or they will be eliminated Participants understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate. Exclusion Criteria: Secondary gout caused by kidney disease, blood disease, drug use, tumor radiotherapy and chemotherapy; Subjects who are using drugs during gout attacks; Malignant diseases: patients with severe lung, cardiovascular, blood and hematopoietic system, central nervous system or other system diseases, as well as tumor patients; Severe obesity (BMI>32kg/m2); Abnormal liver and kidney function: abnormal level of alanine aminotransferase or aspartate aminotransferase; Serum creatinine was higher than the upper limit of the normal range; Allergic to the test drug or weak or allergic; Pregnant or lactating women or those who have pregnancy plans; Sex hormone replacement therapy and oral contraception in the past 3 months; Subjects who have participated in other research projects within three months; Subjects that other researchers considered should be excluded.

Sites / Locations

  • Charlie ZhangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Study Product A (High-dose 2X)

Study Product B (Low-dose X)

Placebo

Arm Description

Amway uric acid lowering product: 5g/sachet, containing the following active ingredients: Celery seed (functional raw material) Dasiphora mandshurica (functional raw material) Cichorium intybus L. (functional raw material) Lotus leaf (functional raw material) Tart cherry (functional raw material) γ-cyclodextrin Erythritol Silicon dioxide Resistant dextrin Black tea essence

Amway uric acid lowering product: 5g/sachet, containing the following active ingredients: Celery seed (functional raw material) Dasiphora mandshurica (functional raw material) Cichorium intybus L. (functional raw material) Lotus leaf (functional raw material) Tart cherry (functional raw material) γ-cyclodextrin Erythritol Silicon dioxide Resistant dextrin Black tea essence

Placebo product: 5g/sachet, containing the following active ingredients: Maltodextrin Pigment Erythritol Bitters Essence of flavor

Outcomes

Primary Outcome Measures

Change of Serum Uric Acid Level
Change of Serum Uric Acid Level from baseline to 12 weeks, in unit of μmol/L, diagnosed as hyperuricemia if the level exceeds 420umol/L twice on different days

Secondary Outcome Measures

Change of Serum Uric Acid Level
Change of Serum Uric Acid Level from baseline to 6 weeks, in unit of μmol/L, diagnosed as hyperuricemia if the level exceeds 420umol/L twice on different days
Fractional Excretion of Uric Acid (FEUA)
Fractional Excretion of Uric Acid (FEUA), defined as the percentage of urate filtered by glomeruli that is excreted in urine, normal range 7~12%. A FEUA value less than 7% considered low, indicating decreased renal excretion of uric acid. A FEUA value above 12% is considered high, suggesting increased renal excretion of uric acid.

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Amway (China) R&D Center
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1. Study Identification

Unique Protocol Identification Number
NCT06084585
Brief Title
The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia
Official Title
A Three Arms, Randomized, Double-blind Controlled Trial of the Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amway (China) R&D Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this three arms, randomized, double-blind controlled interventional study is to evaluate the efficacy of Amway uric acid lowering product improving hyperuricemia in patients aged 18 and 65 years old. The main question it aims to answer is: - whether the serum uric acid level of patients with hyperuricemia could be significantly lowered after 3 months intervention with Amway uric acid lowering product 180 eligible participants will be enrolled in one study site and randomized to three study groups (two product group and one placebo group), who will consume the assigned products for 3 months and be arranged to 3 site visits. All relevant clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis and reporting. Researchers will compare the three study groups to conclude how Amway uric acid lowering product will improve hyperuricemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
Keywords
Uric Acid, Amway

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Product A (High-dose 2X)
Arm Type
Active Comparator
Arm Description
Amway uric acid lowering product: 5g/sachet, containing the following active ingredients: Celery seed (functional raw material) Dasiphora mandshurica (functional raw material) Cichorium intybus L. (functional raw material) Lotus leaf (functional raw material) Tart cherry (functional raw material) γ-cyclodextrin Erythritol Silicon dioxide Resistant dextrin Black tea essence
Arm Title
Study Product B (Low-dose X)
Arm Type
Active Comparator
Arm Description
Amway uric acid lowering product: 5g/sachet, containing the following active ingredients: Celery seed (functional raw material) Dasiphora mandshurica (functional raw material) Cichorium intybus L. (functional raw material) Lotus leaf (functional raw material) Tart cherry (functional raw material) γ-cyclodextrin Erythritol Silicon dioxide Resistant dextrin Black tea essence
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo product: 5g/sachet, containing the following active ingredients: Maltodextrin Pigment Erythritol Bitters Essence of flavor
Intervention Type
Dietary Supplement
Intervention Name(s)
Study Product A (High-dose 2X)
Intervention Description
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Study Product B (Low-dose X)
Intervention Description
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
Primary Outcome Measure Information:
Title
Change of Serum Uric Acid Level
Description
Change of Serum Uric Acid Level from baseline to 12 weeks, in unit of μmol/L, diagnosed as hyperuricemia if the level exceeds 420umol/L twice on different days
Time Frame
baseline, and 12 weeks
Secondary Outcome Measure Information:
Title
Change of Serum Uric Acid Level
Description
Change of Serum Uric Acid Level from baseline to 6 weeks, in unit of μmol/L, diagnosed as hyperuricemia if the level exceeds 420umol/L twice on different days
Time Frame
baseline, and 6 weeks
Title
Fractional Excretion of Uric Acid (FEUA)
Description
Fractional Excretion of Uric Acid (FEUA), defined as the percentage of urate filtered by glomeruli that is excreted in urine, normal range 7~12%. A FEUA value less than 7% considered low, indicating decreased renal excretion of uric acid. A FEUA value above 12% is considered high, suggesting increased renal excretion of uric acid.
Time Frame
baseline, 6 weeks, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants aged between 18 and 65 years old (mostly above 35 years old), including male and female and the ratio of male to female is not limited; Patients with hyperuricemia: meet the diagnostic criteria set out in the "Chinese Guidelines for Diagnosis and Treatment of Hyperuricemia and Gout (2019)", and fasting blood uric acid level exceeds 420 μmol/L twice on different days. Further classification using the Janssens Gout Diagnostic scale included asymptomatic hyperuricemia (that is, never had a gout attack) and patients with a history of gout, with a ratio of about 1:1; Participants agree not to take any drugs, supplements, or performance enhancers during the study, or they will be eliminated Participants understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate. Exclusion Criteria: Secondary gout caused by kidney disease, blood disease, drug use, tumor radiotherapy and chemotherapy; Subjects who are using drugs during gout attacks; Malignant diseases: patients with severe lung, cardiovascular, blood and hematopoietic system, central nervous system or other system diseases, as well as tumor patients; Severe obesity (BMI>32kg/m2); Abnormal liver and kidney function: abnormal level of alanine aminotransferase or aspartate aminotransferase; Serum creatinine was higher than the upper limit of the normal range; Allergic to the test drug or weak or allergic; Pregnant or lactating women or those who have pregnancy plans; Sex hormone replacement therapy and oral contraception in the past 3 months; Subjects who have participated in other research projects within three months; Subjects that other researchers considered should be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@raisonbiotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Cao, MD
Organizational Affiliation
Jinhua Wenrong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charlie Zhang
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie BC Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@raisonbiotech.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32541923
Citation
Dehlin M, Jacobsson L, Roddy E. Global epidemiology of gout: prevalence, incidence, treatment patterns and risk factors. Nat Rev Rheumatol. 2020 Jul;16(7):380-390. doi: 10.1038/s41584-020-0441-1. Epub 2020 Jun 15.
Results Reference
background
PubMed Identifier
16204163
Citation
Choi HK, Mount DB, Reginato AM; American College of Physicians; American Physiological Society. Pathogenesis of gout. Ann Intern Med. 2005 Oct 4;143(7):499-516. doi: 10.7326/0003-4819-143-7-200510040-00009. No abstract available.
Results Reference
background
PubMed Identifier
35197964
Citation
Zhang M, Zhu X, Wu J, Huang Z, Zhao Z, Zhang X, Xue Y, Wan W, Li C, Zhang W, Wang L, Zhou M, Zou H, Wang L. Prevalence of Hyperuricemia Among Chinese Adults: Findings From Two Nationally Representative Cross-Sectional Surveys in 2015-16 and 2018-19. Front Immunol. 2022 Feb 7;12:791983. doi: 10.3389/fimmu.2021.791983. eCollection 2021.
Results Reference
background
PubMed Identifier
32774692
Citation
Li L, Zhang Y, Zeng C. Update on the epidemiology, genetics, and therapeutic options of hyperuricemia. Am J Transl Res. 2020 Jul 15;12(7):3167-3181. eCollection 2020.
Results Reference
background
PubMed Identifier
30562028
Citation
Liu N, Wang Y, Yang M, Bian W, Zeng L, Yin S, Xiong Z, Hu Y, Wang S, Meng B, Sun J, Yang X. New Rice-Derived Short Peptide Potently Alleviated Hyperuricemia Induced by Potassium Oxonate in Rats. J Agric Food Chem. 2019 Jan 9;67(1):220-228. doi: 10.1021/acs.jafc.8b05879. Epub 2018 Dec 28.
Results Reference
background
PubMed Identifier
26320372
Citation
Gliozzi M, Malara N, Muscoli S, Mollace V. The treatment of hyperuricemia. Int J Cardiol. 2016 Jun 15;213:23-7. doi: 10.1016/j.ijcard.2015.08.087. Epub 2015 Aug 8.
Results Reference
background
PubMed Identifier
32717824
Citation
Jiang LL, Gong X, Ji MY, Wang CC, Wang JH, Li MH. Bioactive Compounds from Plant-Based Functional Foods: A Promising Choice for the Prevention and Management of Hyperuricemia. Foods. 2020 Jul 23;9(8):973. doi: 10.3390/foods9080973.
Results Reference
background
PubMed Identifier
36483739
Citation
Yang B, Xin M, Liang S, Xu X, Cai T, Dong L, Wang C, Wang M, Cui Y, Song X, Sun J, Sun W. New insight into the management of renal excretion and hyperuricemia: Potential therapeutic strategies with natural bioactive compounds. Front Pharmacol. 2022 Nov 22;13:1026246. doi: 10.3389/fphar.2022.1026246. eCollection 2022.
Results Reference
background
PubMed Identifier
31702020
Citation
Li S, Li L, Yan H, Jiang X, Hu W, Han N, Wang D. Anti-gouty arthritis and anti-hyperuricemia properties of celery seed extracts in rodent models. Mol Med Rep. 2019 Nov;20(5):4623-4633. doi: 10.3892/mmr.2019.10708. Epub 2019 Sep 26.
Results Reference
background
PubMed Identifier
28630638
Citation
Wang Y, Lin Z, Zhang B, Nie A, Bian M. Cichorium intybus L. promotes intestinal uric acid excretion by modulating ABCG2 in experimental hyperuricemia. Nutr Metab (Lond). 2017 Jun 13;14:38. doi: 10.1186/s12986-017-0190-6. eCollection 2017. Erratum In: Nutr Metab (Lond). 2021 Dec 27;18(1):109.
Results Reference
background
PubMed Identifier
31590257
Citation
Wang Y, Lin Z, Zhang B, Jiang Z, Guo F, Yang T. Cichorium intybus L. Extract Suppresses Experimental Gout by Inhibiting the NF-kappaB and NLRP3 Signaling Pathways. Int J Mol Sci. 2019 Oct 4;20(19):4921. doi: 10.3390/ijms20194921.
Results Reference
background
PubMed Identifier
25499818
Citation
Wang MX, Liu YL, Yang Y, Zhang DM, Kong LD. Nuciferine restores potassium oxonate-induced hyperuricemia and kidney inflammation in mice. Eur J Pharmacol. 2015 Jan 15;747:59-70. doi: 10.1016/j.ejphar.2014.11.035. Epub 2014 Dec 8.
Results Reference
background
PubMed Identifier
37377486
Citation
Cheng-Yuan W, Jian-Gang D. Research progress on the prevention and treatment of hyperuricemia by medicinal and edible plants and its bioactive components. Front Nutr. 2023 Jun 12;10:1186161. doi: 10.3389/fnut.2023.1186161. eCollection 2023.
Results Reference
background
PubMed Identifier
32774405
Citation
Li R, Tan Y, Li Y, Zhu X, Tang X, Zhang L, Chen J. Effects of Tart Cherry Powder on Serum Uric Acid in Hyperuricemia Rat Model. Evid Based Complement Alternat Med. 2020 Jul 22;2020:1454305. doi: 10.1155/2020/1454305. eCollection 2020.
Results Reference
background
PubMed Identifier
31885677
Citation
Chen PE, Liu CY, Chien WH, Chien CW, Tung TH. Effectiveness of Cherries in Reducing Uric Acid and Gout: A Systematic Review. Evid Based Complement Alternat Med. 2019 Dec 4;2019:9896757. doi: 10.1155/2019/9896757. eCollection 2019.
Results Reference
background

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The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

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