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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - no active ingredients | Placebo Comparator | No active ingredients |
|
| Probiotic product | Experimental | Product contains two probiotic strains |
|
| Probiotic product plus fibre | Experimental | Product contains two probiotic strains and a fibre (beta-glucan) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (no active ingredient) | Dietary Supplement | Placebo product containing the same ingredients as the active intervention but without the active compounds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a 6-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo | Baseline-corrected blood urate levels in the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a 3-week intake of a probiotic product on blood urate levels in hyperuricaemic individuals compared to placebo | Baseline-corrected blood urate levels in the probiotic intervention arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Recruiting | Örebro | Sweden |
According to Swedish ethics regulations, IPD cannot be shared without an approved ethics application from the National Swedish Ethics Authority. An ethical permit can only be obtained for research being conducted within Sweden.
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Probiotics | Dietary Supplement | Product contains two probiotic strains |
|
| Probiotics plus fibre | Dietary Supplement | Product contains two probiotic strains plus a fibre (beta-glucan) |
|
Baseline-corrected blood urate levels in the probiotic plus fibre intervention arm after three weeks will be compared to the levels in the placebo arm |
| 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 | Baseline-corrected blood urate levels in the probiotic plus fibre intervention arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo | Baseline-corrected blood urate-related metabolite levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on blood urate-related metabolites in hyperuricaemic individuals compared to placebo | Baseline-corrected blood urate-related metabolite levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected blood urate-related metabolite levels in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected blood urate-related metabolite levels in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo | Baseline-corrected blood urate-related enzyme levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on blood urate-related enzymes in hyperuricaemic individuals compared to placebo | Baseline-corrected blood urate-related enzyme levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 6 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 | Baseline-corrected blood urate-related enzyme levels in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected blood urate-related enzyme levels in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo | Baseline-corrected urate-related metabolite levels in stool samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on urate-related metabolites in stool of hyperuricaemic individuals compared to placebo | Baseline-corrected urate-related metabolite levels in stool samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate-related metabolite levels in stool samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 3 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 | Baseline-corrected urate-related metabolite levels in stool samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo | Baseline-corrected urate-related enzyme levels in stool samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on urate-related enzymes in stool of hyperuricaemic individuals compared to placebo | Baseline-corrected urate-related enzymes levels in stool samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate-related enzyme levels in stool samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate-related enzyme levels in stool samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo | Baseline-corrected urate-related enzymes levels in urine samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on urate-related enzymes in urine of hyperuricaemic individuals compared to placebo | Baseline-corrected urate-related enzymes levels in urine samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 6 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 | Baseline-corrected urate-related enzymes levels in urine samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate-related enzymes levels in urine samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on inflammation markers in blood of hyperuricaemic individuals compared to placebo | Baseline-corrected inflammation markers in blood samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on inflammation markers in blood of hyperuricaemic individuals compared to placebo | Baseline-corrected inflammation markers in blood samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected inflammation markers in blood samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected inflammation markers in blood samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on inflammation markers in stool of hyperuricaemic individuals compared to placebo | Baseline-corrected inflammation markers in stool samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on inflammation markers in stool of hyperuricaemic individuals compared to placebo | Baseline-corrected inflammation markers in stool samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected inflammation markers in stool samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected inflammation markers in stool samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo | Baseline-corrected blood creatinine levels (eGFR - estimated glomerular filtration rate) in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on blood creatinine levels of hyperuricaemic individuals compared to placebo | Baseline-corrected blood creatinine levels (eGFR - estimated glomerular filtration rate) in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected blood creatinine levels (eGFR - estimated glomerular filtration rate) in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected blood creatinine levels (eGFR - estimated glomerular filtration rate) in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo | Baseline-corrected urine creatinine levels in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on urine creatinine levels of hyperuricaemic individuals compared to placebo | Baseline-corrected urine creatinine levels in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urine creatinine levels in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urine creatinine levels in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on urate levels in stool of hyperuricaemic individuals compared to placebo | Baseline-corrected urate levels in stool samples of the probiotic intervention arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on urate levels in stool of hyperuricaemic individuals compared to placebo | Baseline-corrected urate levels in stool samples of the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate levels in stool samples of the probiotic plus fibre intervention arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate levels in stool samples of the probiotic plus fibre intervention arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on urate levels in urine of hyperuricaemic individuals compared to placebo | Baseline-corrected urate levels in urine samples of the probiotic intervention arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on urate levels in urine of hyperuricaemic individuals compared to placebo | Baseline-corrected urate levels in urine samples of the probiotic intervention arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate levels in urine samples of the probiotic plus fibre intervention arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate levels in urine samples of the probiotic plus fibre intervention arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| Effect of a 3-week intake of a probiotic product on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo | Baseline-corrected urate-related metabolite levels in urine samples in the probiotic arm after three weeks will be compared to the levels in the placebo arm | 3 weeks |
| Effect of a 6-week intake of a probiotic product on urate-related metabolites in urine of hyperuricaemic individuals compared to placebo | Baseline-corrected urate-related metabolite levels in urine samples in the probiotic arm after six weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate-related metabolite levels in urine samples in the probiotic plus fibre arm after three weeks will be compared to the levels in the placebo arm | 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 | Baseline-corrected urate-related metabolite levels in urine samples in the probiotic plus fibre arm after six weeks will be compared to the levels in the placebo arm | 6 weeks |
| D019602 |
| Food and Beverages |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |