Effect of Prebiotics on Hyperuricemia

NCT05385003 | Unknown

• 1 other identifier: Pre-2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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. This trial aims to examine its protective effect in humans.

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 blood pressure

  from baseline to 12 weeks after intervention

• Change in fasting glucose

  from baseline to 12 weeks after intervention

• Change in waist circumference

  from baseline to 12 weeks after intervention

Study Arms (3)

Dietary Supplement: anserine

EXPERIMENTAL

Subjects are instructed to take one capsule of anserine daily for a total of 3 months

Dietary Supplement: anserine

Dietary Supplement: Sunflower peptide

EXPERIMENTAL

Subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months

Dietary Supplement: Sunflower peptide

Dietary Supplement: Placebo control

PLACEBO COMPARATOR

Subjects are instructed to take one capsule of placebo daily for a total of 3 months

Dietary Supplement: Placebo control

Interventions

anserine DIETARY_SUPPLEMENT

During the study period, subjects are instructed to take one capsule of anserine daily for a total of 3 months. Aside from the prebiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.

Dietary Supplement: anserine

Sunflower peptide DIETARY_SUPPLEMENT

During the study period, subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months. Aside from the prebiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.

Dietary Supplement: Sunflower peptide

Placebo control DIETARY_SUPPLEMENT

During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.

Dietary Supplement: Placebo control

Eligibility Criteria

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

You may qualify if:

• Local residents aged between 18-65 years old;
• Stable weight (\<5% weight change over last 3 months);
• Fasting uric acid was \> 420μmol/L for male and \> 360μmol/L for female on two different days
• Those who have never taken uric acid lowering drugs or have stopped taking uric acid lowering drugs for at least four weeks;
• Absence of any diet or medication that might interfere with Uric acid metabolism and gut microbiota, especially antibiotics and probiotics at 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 surgery within the past six 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

Anserine; SFTI-1 peptide, sunflower

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Min Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Xia, PhD

CONTACT

+86-20-87332433; xiamin@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 13, 2022
• First Posted: May 23, 2022
• Study Start: May 14, 2022
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)