The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

October 10, 2023 updated by: Amway (China) R&D Center

A Three Arms, Randomized, Double-blind Controlled Trial of the Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study Product A (High-dose 2X)

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)
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months
Active Comparator: Study Product B (Low-dose X)

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)
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 Comparator: Placebo

Placebo product: 5g/sachet, containing the following active ingredients:

  • Maltodextrin
  • Pigment
  • Erythritol
  • Bitters
  • Essence of flavor
Dietary supplement: Placebo
participants in this arm will consume 1 sachet of this product with 200ml water per time, once a day after meal, for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Serum Uric Acid Level
Time Frame: baseline, and 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Serum Uric Acid Level
Time Frame: baseline, and 6 weeks
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
baseline, and 6 weeks
Fractional Excretion of Uric Acid (FEUA)
Time Frame: baseline, 6 weeks, and 12 weeks
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.
baseline, 6 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amway (China) R&D Center

Investigators

  • Principal Investigator: Dan Cao, MD, Jinhua Wenrong Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 23, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-RB-07-AY-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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