The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

NCT06084585 | Unknown

• 1 other identifier: 22-RB-07-AY-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperuricemia

Keywords

Uric Acid; Amway

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, and 12 weeks

Secondary Outcomes (2)

• Change of Serum Uric Acid Level

  baseline, and 6 weeks

• Fractional Excretion of Uric Acid (FEUA)

  baseline, 6 weeks, and 12 weeks

Study Arms (3)

Study Product A (High-dose 2X)

ACTIVE COMPARATOR

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

Dietary Supplement: Study Product A (High-dose 2X)

Study Product B (Low-dose X)

ACTIVE COMPARATOR

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

Dietary Supplement: Study Product B (Low-dose X)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Study Product A (High-dose 2X) DIETARY_SUPPLEMENT

participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months

Study Product A (High-dose 2X)

Study Product B (Low-dose X) DIETARY_SUPPLEMENT

participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months

Study Product B (Low-dose X)

Placebo DIETARY_SUPPLEMENT

participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amway (China) R&D Center: lead

Study Sites (1)

Charlie Zhang

Jinhua, Zhejiang, China

RECRUITING

Related Publications (15)

• 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.

  PMID: 32541923 BACKGROUND

• 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.

  PMID: 16204163 BACKGROUND

• 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.

  PMID: 35197964 BACKGROUND

• 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.

  PMID: 32774692 BACKGROUND

• 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.

  PMID: 30562028 BACKGROUND

• 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.

  PMID: 26320372 BACKGROUND

• 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.

  PMID: 32717824 BACKGROUND

• 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.

  PMID: 36483739 BACKGROUND

• 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.

  PMID: 31702020 BACKGROUND

• 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.

  PMID: 28630638 BACKGROUND

• 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.

  PMID: 31590257 BACKGROUND

• 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.

  PMID: 25499818 BACKGROUND

• 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.

  PMID: 37377486 BACKGROUND

• 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.

  PMID: 32774405 BACKGROUND

• 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.

  PMID: 31885677 BACKGROUND

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dan Cao, MD

  Jinhua Wenrong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlie Zhang, MD

CONTACT

+8613901981272; charlie.zhang@raisonbiotech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: October 23, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 15, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)