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

Early Phase 1

Completed

• Conditions: Hyperuricemia
• Interventions: Combination Product: Combination of Plant Extracts (BSL_EP026); Combination Product: Control

• Registration Number: NCT04165499
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-11-11
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of Plant Extracts (BSL_EP026)	Combination of Plant Extracts (BSL_EP026)	Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL_EP026).
Control	Control	Volunteers will take 1 capsule twice daily with maltodextrin.

Primary Outcome Measures

Name	Time	Method
Uric acid	2 weeks	Uric acid in plasma

Secondary Outcome Measures

Name	Time	Method
Blood pressure	2 weeks	Systolic and diastolic pressure during the study
pH of urine	2 weeks	pH in morning spot urine
Fractional clearance of urate (FCU)	2 weeks	Renal clearance of urate/Renal clearance of creatinine
Uric acid in urine	2 weeks	Uric acid in morning spot urine

Trial Locations

Locations (1)

Biosearch Life; 🇪🇸 Granada, Andalucia, Spain