NCT04165499

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

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.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combination of Plant Extracts (BSL_EP026)	Each participant will consume 2 capsules daily, in the morning and in the evening.
COMBINATION_PRODUCT	Control	Each participant will consume 2 capsules daily, in the morning and in the evening.

Timeline

• Start date: 2019-11-11
• Primary completion: 2020-03-20
• Completion: 2020-03-20
• First posted: 2019-11-18
• Last updated: 2020-05-13

Locations

1 site across 1 country: Spain