Clinical trial NCT04165499: Effect of the Consumption of a Combination of Plant Extracts (BSL_EP026) on Serum Uric Acid.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperuricemia
Keywords: Hyperuricemia
Plant extracts
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
Collaborators: name: Clínica Dr. Miguel Quesada
First posted: 2019-11-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Uric acid
timeFrame: 2 weeks
Secondary outcomes:
measure: Uric acid in urine
timeFrame: 2 weeks
measure: pH of urine
timeFrame: 2 weeks
measure: Blood pressure
timeFrame: 2 weeks
measure: Fractional clearance of urate (FCU)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Biosearch Life
state: Andalucia
Study officials:
affiliation: Clínica Dr. Quesada
name: Miguel Quesada, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: