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

Biosearch Life

Status and phase: Completed; Early Phase 1

Conditions: Hyperuricemia

Treatments: Combination Product: Combination of Plant Extracts (BSL_EP026); Combination Product: Control

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04165499

C026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Combination of Plant Extracts (BSL_EP026)

Experimental group

Description:

Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL_EP026).

Treatment:

Combination Product: Combination of Plant Extracts (BSL_EP026)

Control

Placebo Comparator group

Description:

Volunteers will take 1 capsule twice daily with maltodextrin.

Treatment:

Combination Product: Control