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

NCT ID: NCT04165499

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2020-03-20

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.

Conditions

Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Combination of Plant Extracts (BSL_EP026)

Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL\_EP026).

Group Type: EXPERIMENTAL

Combination of Plant Extracts (BSL_EP026)

Intervention Type: COMBINATION_PRODUCT

Each participant will consume 2 capsules daily, in the morning and in the evening.

Control

Volunteers will take 1 capsule twice daily with maltodextrin.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: COMBINATION_PRODUCT

Each participant will consume 2 capsules daily, in the morning and in the evening.

Interventions

Combination of Plant Extracts (BSL_EP026)

Each participant will consume 2 capsules daily, in the morning and in the evening.

Intervention Type: COMBINATION_PRODUCT

Control

Each participant will consume 2 capsules daily, in the morning and in the evening.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Placebo group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clínica Dr. Miguel Quesada

UNKNOWN

Sponsor Role: collaborator

Biosearch S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel Quesada, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clínica Dr. Quesada

Locations

Biosearch Life

Granada, Andalusia, Spain

Countries

Spain

Other Identifiers

C026

Identifier Type: -

Identifier Source: org_study_id