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.

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.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia
• Intervention / Treatment: Combination product: Combination of Plant Extracts (BSL_EP026); Combination product: Control

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Granada, Andalucia, Spain, 18004
      • Biosearch Life

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination of Plant Extracts (BSL_EP026); Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL_EP026).	Combination product: Combination of Plant Extracts (BSL_EP026); Each participant will consume 2 capsules daily, in the morning and in the evening.
Placebo Comparator: Control; Volunteers will take 1 capsule twice daily with maltodextrin.	Combination product: Control; Each participant will consume 2 capsules daily, in the morning and in the evening.; Other Names: Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uric acid	Uric acid in plasma	2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Collaborators: Clínica Dr. Miguel Quesada
• Investigators: Principal Investigator: Miguel Quesada, MD, PhD, Clínica Dr. Quesada

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Hyperuricemia; Plant extracts
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: C026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No