Effect of the Consumption of a Combination of Plant Extracts (BSL_EP026) on Serum Uric Acid.

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effect of the combination of a combination of plant extracts (BSL_EP026) on blood and urine uricemia levels in individuals with levels at the limit of the values considered normal or moderately high.

Detailed Description
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Hyperuricemia is an abnormally high level of uric acid in the blood, resulted because of an increased production of uric acid, decreased excretion of uric acid, or both. This can cause gout and nephrolithiasis, and it has also been related to metabolic syndrome, diabetes mellitus, cardiovascular disease and chronic kidney disease. Some plant extracts have diuretic activity that could contribute to improve uric acid excretion. This effect would lead to a decrease in uric acid plasma levels and, secondarily, to an action on its metabolic pathway of endogenous biogeneration. On the other hand, uric acid has a double reabsorption-elimination step in the renal tubules and the flavonoids of both extracts impede the processes of renal resorption promoting urinary elimination, in addition to increase the pH of the urine (higher than pH 5.8), which favors the non-precipitation or formation of urate stones. Finally, the routine (present in the used extracts) inhibit the uric acid formation pathway from purines, which would act synergistically. In this project, the effect of the intake of a combination plant extracts on uricemia levels will be studied.

Official Title
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Preliminary Study of Nutritional Intervention, Randomized, Double Blind, and Controlled Parallel Groups to Evaluate the Effect of Consuming a Combination of of Plant Extracts (BSL_EP026) on Serum Uric Acid in Hypeuricemic Subjects.

Conditions
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Hyperuricemia

Intervention / Treatment
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* Combination Product: Combination of Plant Extracts (BSL_EP026)
* Combination Product: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blood uric acid levels greater than 7 mg/dL in men and 6 mg dL in women. Accept freely to participate in the study and sign the informed consent document. Exclusion Criteria: Having treatment that can affect uric acid levels. Use of diuretics. Follow a low purine diet. Take a food supplement or drug that interferes with uric acid metabolism and renal system function. Have an allergy to birch and/or orthosiphon or another component of the test products. Low compliance expectation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of Plant Extracts (BSL_EP026)<br>Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL_EP026). | Combination Product: Combination of Plant Extracts (BSL_EP026)<br>* Each participant will consume 2 capsules daily, in the morning and in the evening.<br>|
| Placebo Comparator: Control<br>Volunteers will take 1 capsule twice daily with maltodextrin. | Combination Product: Control<br>* Each participant will consume 2 capsules daily, in the morning and in the evening.<br>* Other names: Placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uric acid | Uric acid in plasma | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uric acid in urine | Uric acid in morning spot urine | 2 weeks | 
| pH of urine | pH in morning spot urine | 2 weeks | 
| Blood pressure | Systolic and diastolic pressure during the study | 2 weeks | 
| Fractional clearance of urate (FCU) | Renal clearance of urate/Renal clearance of creatinine | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperuricemia, Plant extracts