GOS and the Management of Hyperuricemia

NCT06630377 | Recruiting

• 1 other identifier: GOS-HUA-2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperuricemia is a major risk factor for many chronic diesease. Recently, gut mcirobiota has been identified as a novel therapeutic 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 the protective effects and potential mechanisms of galactooligosaccharide on hyperuricemia in clinical trials.

Conditions

Subjects With Hyperuricemia

Outcome Measures

Primary Outcomes (2)

• Change of serum uric acid

  change of serum uric acid level assessed by automatic biochemical detector

  from baseline to 8 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 with automatic biochemical detector

  from baseline to 8 weeks after intervention

Secondary Outcomes (2)

• Change of gut microbiota

  from baseline to 8 weeks after intervention

• Change of microbial metabolites in the circulation

  from baseline to 8 weeks after intervention

Study Arms (2)

Dietary intervention with GOS

EXPERIMENTAL

Eligible subjects are instructed to take one pocket of galactooligosaccharide during the first week, followed by two pockets of galactooligosaccharide during the remaining 7 weeks.

Dietary Supplement: GOS

Dietary intervention with Placebo

PLACEBO COMPARATOR

Eligible subjects are instructed to take one pocket of maltodextrin during the first week, followed by two pockets of maltodextrin during the remaining 7 weeks.

Dietary Supplement: Placebo

Interventions

GOS DIETARY_SUPPLEMENT

During the study period, subjects are instructed to take one pocket of galactooligosaccharide per day during the first week, followed by two pockets of galactooligosaccharide per day during the remaining 7 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 intervention with GOS

Placebo 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 remaining 7 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 intervention with 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);
• Fasting 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 metabolism 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 inflammatory of infective diseases;
• Participation in regular diet program more than 2 times per week in the latest 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 pregnant, 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 (1)

Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Officials

• Min Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Liu, PhD

CONTACT

+86-20-87331937; 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: July 3, 2024
• First Posted: October 8, 2024
• Study Start: July 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)