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

Hyperuricemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165499
• Other study ID #: C026
• Status: Completed
• Phase: Early Phase 1
• Start date: November 11, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: July 2019
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Combination Product:
• Combination of Plant Extracts (BSL_EP026)
Each participant will consume 2 capsules daily, in the morning and in the evening.
• Control
Each participant will consume 2 capsules daily, in the morning and in the evening.

Locations

Country	Name	City	State
Spain	Biosearch Life	Granada	Andalucia

Sponsors (2)

Lead Sponsor	Collaborator
Biosearch S.A.	Clínica Dr. Miguel Quesada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uric acid	Uric acid in plasma	2 weeks
Secondary	Uric acid in urine	Uric acid in morning spot urine	2 weeks
Secondary	pH of urine	pH in morning spot urine	2 weeks
Secondary	Blood pressure	Systolic and diastolic pressure during the study	2 weeks
Secondary	Fractional clearance of urate (FCU)	Renal clearance of urate/Renal clearance of creatinine	2 weeks