## Protocol Section
### Identification Module
**NCT ID:** NCT06420401

**Brief Title:** Prebiotics and the Management of Hyperuricemia

**Official Title:** Precision Treatment of Hyperuricemia Based on Different Combinations of Prebiotics

#### Organization Study ID Info
**ID:** Prebiotics-2024
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sun Yat-sen University

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** Min Xia

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Hyperuricemia is a major risk factor for many chronic diesease. Recently, gut mcirobiota has been identified as a novel theraputic target for hyperuricemia. Both annimal studies and pilot human trials have demonstrated that administration of prebiotics help delay the progression of hyperuricemia throuh several mechanisms. This trial aims to examine its protective effects and potential mechanisms in clinical trials.

**Detailed Description:** Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids and hippuric acid.

However, whether administration of prebiotics also has a protective effect in subjects with hyperuricemia remain under-explored. Moreover, whether the original gut microbiota will influence the protective effect of prebiotics remains largely unknown.

### Conditions Module

**Conditions:**

- Subjects With Hyperuricemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 160

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Eligilable subjects are instructed to take one pocket of araboxylan during the first week, followed by two pockets of araboxylan during the remaining 11 weeks.

**Intervention Names:**

- Dietary Supplement: araboxylan

**Label:** Dietary supplement: araboxylan

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Eligilable subjects are instructed to take one pocket of inulin during the first week, followed by two pockets of inulin during the remaining 11 weeks.

**Intervention Names:**

- Dietary Supplement: inulin

**Label:** Dietary supplement: inulin

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Eligilable subjects are instructed to take one pocket of inulin and arabosylan during the first week, followed by two pockets of inulin and araboxylan during the remaining 11 weeks.

**Intervention Names:**

- Dietary Supplement: inulin and araboxylan

**Label:** Dietary supplement: inulin and araboxylan

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Eligilable subjects are instructed to take one pocket of maltodextrin during the first week, followed by two pockets of maltodextrin during the remaining 11 weeks.

**Intervention Names:**

- Dietary Supplement: placebo control

**Label:** Dietary supplement: placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dietary supplement: araboxylan

**Description:** During the study period, subjects are instructed to take one pocket of arabosylan per day during the first week, followed by two pockets of araboxylan per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity.

**Name:** araboxylan

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Dietary supplement: inulin

**Description:** During the study period, subjects are instructed to take one pocket of inulin per day during the first week, followed by two pockets of inulin per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity.

**Name:** inulin

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- Dietary supplement: inulin and araboxylan

**Description:** During the study period, subjects are instructed to take one pocket of inulin and araboxylan per day during the first week, followed by two pockets of inulin and araboxylan per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity.

**Name:** inulin and araboxylan

**Type:** DIETARY_SUPPLEMENT

#### Intervention 4

**Arm Group Labels:**

- Dietary supplement: placebo

**Description:** During the study period, subjects are instructed to take one pocket of placebo control per day during the first week, followed by two pockets of placebo control per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity.

**Name:** placebo control

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** change of fasting uric acid level assessed by biochemical detector

**Measure:** Change of serum uric acid

**Time Frame:** from baseline to 12 weeks after intervention

**Description:** excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours

**Measure:** Change of excretion of uric acid

**Time Frame:** from baseline to 12 weeks after intervention

#### Secondary Outcomes

**Description:** Alterations of the composition of gut microbiota evaluated by metagenomics

**Measure:** Change of gut microbiota

**Time Frame:** from baseline to 12 weeks after intervention

**Description:** Untargeted metabolomics will be used to assess the alterations of microbial metabolites with high performance liquid chromatography-mass spectrometry

**Measure:** Change of microbial metabolites

**Time Frame:** from baseline to 12 weeks after intervention

**Description:** HOMA-IR will be used to assess the change of insulin sensitivity

**Measure:** Change in insulin sensitivity

**Time Frame:** from baseline to 12 weeks after intervention

**Description:** change in waist circumference assessed by tape

**Measure:** Change in waist circumference

**Time Frame:** from baseline to 12 weeks after intervention

**Description:** change in blood pressure assessed by electronic sphymomanometer

**Measure:** Change in blood pressure

**Time Frame:** from baseline to 12 weeks after intervention

**Description:** change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector

**Measure:** Change in lipid profiles

**Time Frame:** from baseline to 12 weeks after intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Local residents aged between 18-80 years old;

  * Stable weight (\<5% weight change over the past 3 months);
  * Fsating uric acid \> 420 umol/L for male and \> 360 umol/L for female on two different days;
  * Not taking uric acid lowering drugs or have stopped taking uric acid lowering drugs for over 4 weeks at the time of recruitment;
  * Absence of any diet or medication that might interfere with uric acid metabolims or gut microbiota, especially antibiotics, prebiotics or probiotics at the least 4 weeks before recruitment

Exclusion Criteria:

* Acute illness or evidence of any acute or chronic inflammatroy of infective diseases;

  * Participation in regular diet program more than 2 times per week in the lastest 3 months prior to recruitment;
  * Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study;
  * Women of childbearing age who are pregant, breast-feeding or preparing for pregnancy; patients who had surgey within the past 6 months or planned surgery during the trial period.

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** liuyan215@mail.sysu.edu.cn

**Name:** Yan Liu, PhD

**Phone:** +86-20-87331974

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** xiamin@mail.sysu.edu.cn

- **Name:** Min Xia, PhD

- **Phone:** +86-2087332433

- **Role:** CONTACT

**Country:** China

**Facility:** Sun Yat-Sen University

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510080

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M24343

- Name: Hyperuricemia

- Relevance: HIGH

- As Found: Hyperuricemia

### Condition Browse Module - Meshes

- ID: D000033461

- Term: Hyperuricemia

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T401

- Name: Inulin

- Relevance: HIGH

- As Found: GnRH

### Misc Info Module

- Version Holder: 2024-05-31
