Asymptomatic Hyperuricemia
Conditions
Brief summary
This study aims to utilize a randomized controlled trial in asymptomatic hyperuricemic individuals to clarify the effects of four probiotic strains including Lactobacillus acidophilus on serum uric acid levels, pathways of uric acid synthesis, degradation and excretion, hyperuricemia-induced oxidative stress and chronic inflammatory responses, uric acid-related metabolites, gut microbiota composition and diversity.
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic products (6 × 10\^9 CFU per day)
DIETARY_SUPPLEMENTPlacebo
Placebo (without probiotics, with other ingredients consistent with probiotic products)
Sponsors
Sun Yat-sen University
The Eighth Affiliated Hospital of Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged 18-65; * Residents who have lived in Guangdong for more than one year; * According to the "Chinese Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia-Related Diseases (2023 Edition)", asymptomatic HUA is defined as a fasting serum uric acid level \>420 umol /L and no history of gout symptoms such as gouty arthritis; * Consent to be randomly assigned to the intervention or control group; * Willing to consume the probiotic products provided by the study;
Exclusion criteria
* Secondary HUA caused by disease or drugs; * Within 3 months before participating in the study, or currently taking drugs that affect uric acid metabolism, such as azathioprine, thiazide diuretics, prednisone, etc., and unwilling to stop taking them during the study; * Taking or currently taking medication for gout within 3 months before participating in the study and unwilling to stop taking it during the study; * Abnormal liver function (AST or ALT levels are more than 3 times the upper limit of normal), abnormal renal function (glomerular filtration rate less than 60mL/min/1.73m\^2); * Abnormal blood test results (such as white blood cell count \< 3.5x10\^9 /L, platelet count \< 100x10\^9 /L, hemoglobin \< 90g/L) or other blood system diseases; * Suffering from severe cardiovascular, kidney, gastrointestinal, hepatal, and malignant tumor diseases; * Long-term or current use of nonsteroidal anti-inflammatory drugs, antibiotics, antihistamines, or immunomodulatory drugs, and inability to stop using these drugs within 72 hours before the start of the study; * Currently taking anticoagulants, anabolic steroids, hydrocortisone and other hormonal drugs; * Use of probiotic supplements within one month prior to participating in the study, and was unwilling to discontinue taking them during the study; * Frequent use (more than once a day) of multivitamins, antioxidants, herbal supplements, dietary fiber-containing supplements, and other nutritional supplements (such as inulin, fish oil, soy lecithin, niacin, dietary fiber, flaxseed, phytoestrogens, sterols, etc.), or products containing prebiotics, probiotics, synbiotics, postbiotics, etc. (such as yogurt, fermented milk, beverages, or other fermented products) within 3 months prior to study participation, and unwilling to stop taking them; * Self-reported weight loss of more than 7 kg or 10% in the 6 months prior to enrollment; * Suffering from eating disorders (such as anorexia and bulimia), dysphagia, or difficulty swallowing food or medication; * Unable to consume the probiotic products provided by the study as required during the study period; * Drink more than 2 times a day, more than 14 times a week, and are unwilling to stop drinking during the study; * Intolerance or food allergy related to the investigational product, drug allergy, or other issues that may affect food intake; * Poor venous access; * Women who have given birth in the past year, are pregnant, or plan to become pregnant within 6 months, or are breastfeeding; * Participating or planning to participate in other dietary intervention studies, drug use studies, or cosmetic or pharmaceutical application studies in the next three months; * Participated in clinical trials in the past 3 months; * Any other condition that is deemed unsuitable for the trial by a physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood uric acid | Weeks 0,4,8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood urea nitrogen | Weeks 0,4,8 | — |
| Blood creatinine | Weeks 0,4,8 | — |
| Blood xanthine | Weeks 0,8 | — |
| Blood hypoxanthine | Weeks 0,8 | — |
| Blood xanthine oxidase | Weeks 0,8 | — |
| Fecal uric acid | Weeks 0,8 | — |
| Fecal allantoin | Weeks 0,8 | — |
| Urine uric acid | Weeks 0,8 | — |
| Urine allantoin | Weeks 0,8 | — |
| Serum diamine oxidase | Weeks 0,8 | — |
| Urine oxidative stress indicator level | Weeks 0,8 | — |
| Blood inflammatory cytokine levels | Weeks 0,8 | Quantitative measurement of chronic inflammatory biomarkers in blood serum or plasma, such as high-sensitivity C-reactive protein (hs-CRP). |
| Fecal gut microbiota | Weeks 0,8 | Analyzing the composition of gut microbiota using metagenomic sequencing technology. DNA will be extracted from fecal samples using commercial kits, followed by library preparation and sequencing. |
| Metabolomics | Weeks 0,8 | Non-targeted metabolomics using LC-MS (liquid chromatography-mass spectrometry). |
Countries
China
Outcome results
None listed