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.
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Hyperuricemia
- Sponsor
- Biosearch S.A.
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Uric acid
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Uric acid
Time Frame: 2 weeks
Uric acid in plasma
Secondary Outcomes
- Blood pressure(2 weeks)
- pH of urine(2 weeks)
- Fractional clearance of urate (FCU)(2 weeks)
- Uric acid in urine(2 weeks)