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The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

Sponsor
Amway (China) R&D Center (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06084585
Collaborator
(none)
180
Enrollment
1
Location
3
Arms
4.7
Anticipated Duration (Months)
38
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Study Product A (High-dose 2X)
  • Dietary Supplement: Study Product B (Low-dose X)
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
A Three Arms, Randomized, Double-blind Controlled Trial of the Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia
Anticipated Study Start Date :
Oct 23, 2023
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Mar 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change of Serum Uric Acid Level [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

Secondary Outcome Measures

  1. Change of Serum Uric Acid Level [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

  2. Fractional Excretion of Uric Acid (FEUA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charlie Zhang Jinhua Zhejiang China

Sponsors and Collaborators

  • Amway (China) R&D Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amway (China) R&D Center
ClinicalTrials.gov Identifier:
NCT06084585
Other Study ID Numbers:
  • 22-RB-07-AY-001
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amway (China) R&D Center
Uric Acid
Amway
Additional relevant MeSH terms:
Hyperuricemia

Study Results

No Results Posted as of Oct 16, 2023