Prebiotics and the Management of Hyperuricemia

NCT06420401 | Recruiting

• 1 other identifier: Prebiotics-2024
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Subjects With Hyperuricemia

Outcome Measures

Primary Outcomes (2)

• Change of serum uric acid

  change of fasting uric acid level assessed by biochemical detector

  from baseline to 12 weeks after intervention

• Change of excretion of uric acid

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

  from baseline to 12 weeks after intervention

Secondary Outcomes (6)

• Change of gut microbiota

  from baseline to 12 weeks after intervention

• Change of microbial metabolites

  from baseline to 12 weeks after intervention

• Change in insulin sensitivity

  from baseline to 12 weeks after intervention

• Change in waist circumference

  from baseline to 12 weeks after intervention

• Change in blood pressure

  from baseline to 12 weeks after intervention

Study Arms (4)

Dietary supplement: araboxylan

EXPERIMENTAL

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.

Dietary Supplement: araboxylan

Dietary supplement: inulin

EXPERIMENTAL

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.

Dietary Supplement: inulin

Dietary supplement: inulin and araboxylan

EXPERIMENTAL

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.

Dietary Supplement: inulin and araboxylan

Dietary supplement: placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: placebo control

Interventions

araboxylan DIETARY_SUPPLEMENT

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.

Dietary supplement: araboxylan

inulin DIETARY_SUPPLEMENT

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.

Dietary supplement: inulin

inulin and araboxylan DIETARY_SUPPLEMENT

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.

Dietary supplement: inulin and araboxylan

placebo control DIETARY_SUPPLEMENT

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.

Dietary supplement: placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Department of Nutrition and Food Hygiene

Guangzhou, Guangdong, 510080, China

RECRUITING

Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Central Study Contacts

Yan Liu, PhD

CONTACT

+86-20-87331974; liuyan215@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: May 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)