NCT07141888尚未招募不适用
The Effects of a Novel Probiotic Food Supplement in Hyperuricaemia - Towards Development of an Individualised Treatment Strategy
Örebro University, Sweden1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Effect of a 6-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo
研究概览
简要总结
The overall aim of the project is to determine whether a daily intake of health-promoting bacteria, known as probiotics, with or without a dietary fiber, affects uric acid levels in individuals with elevated levels of uric acid in the blood (hyperuricemia). Additionally, the project will investigate which individuals benefit from this dietary supplement and which do not, based on factors such as gut microbiota composition and function, dietary habits, genetic factors, and inflammatory status. The ultimate goal is to develop a personalized therapy for hyperuricemia.
At the beginning of the study, blood samples will be taken to determine uric acid levels and 99 individuals with hyperuricemia will be invited to participate in a 6-week intervention study with daily intake of dietary supplements. To examine the effect of the supplement on various health variables, blood, urine, stool, and breath samples will be collected on several occasions.
To better understand the underlying factors of hyperuricemia, questionnaire data and results from biological will be compared between participants with normal versus elevated uric acid levels. Furthermore, different outcome parameters from questionnaires and samples before and after supplement intake will be compared. In addition, various methods for estimating dietary intake will be investigated and compared with each other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-related procedures
- •Age 18-80 years old
- •BMI range 17.5-40 kg/m2
- •Blood uric acid above 405 μmol/l (6.8 mg/dl)
- •Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages) during the study
- •Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study
排除标准
- •Recent (within last month) episode of gout
- •Diagnosis of type 1 diabetes
- •Diagnosed inflammatory bowel disease (IBD)
- •Current diagnosis of psychiatric disease/s or syndromes
- •Current diagnosis of neurodegenerative disease
- •Current pregnancy or breastfeeding
- •History of complicated gastrointestinal surgery
- •(Partial) resection of the small intestine or colon
- •Regular use of urate-lowering treatment (apart from allopurinol) in the month prior to inclusion
- •Oral or intravenous administration of antibiotics and/or corticosteroids in the 4 months prior to inclusion
- •Regular use of any non-steroidal anti-inflammatory drug (NSAID) during the last month prior to inclusion (apart from low-dose acetylsalicylic acid)
- •Consumption of more than 9 standard glasses of alcohol-containing drinks per week and/or more than 4 standard glasses per occasion
- •Regular use of probiotic or prebiotic supplementation in the month prior to inclusion
- •Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion
结局指标
主要结局
Effect of a 6-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo
时间窗: 6 weeks
Baseline-corrected blood urate levels in the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm
次要结局
- Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate levels in hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate-related metabolites in hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate-related enzymes in hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on inflammation markers in blood of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 3-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on inflammation markers in blood of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on blood urate levels in hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate-related metabolites in hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 3-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on blood urate-related enzymes in hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 6-week intake of a probiotic product on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 6-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on inflammation markers in blood of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on inflammation markers in blood of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on inflammation markers in stool of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on inflammation markers in stool of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on inflammation markers in stool of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on inflammation markers in stool of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on blood creatinine levels of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on blood creatinine levels of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on urine creatinine levels of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on urine creatinine levels of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on urate levels in stool of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on urate levels in stool of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on urate levels in stool of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on urate levels in stool of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on urate levels in urine of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on urate levels in urine of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on urate levels in urine of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on urate levels in urine of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo(6 weeks)
- Effect of a 3-week intake of a probiotic product in combination with a fibre on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo(3 weeks)
- Effect of a 6-week intake of a probiotic product in combination with a fibre on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo(6 weeks)
研究者
Julia König, PhD
Associate professor, PhD
Örebro University, Sweden
研究点 (1)
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