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

Primary Purpose

Hyperuricemia

Status
Completed
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Combination of Plant Extracts (BSL_EP026)
Control
Sponsored by
Biosearch S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia focused on measuring Hyperuricemia, Plant extracts

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Biosearch Life

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combination of Plant Extracts (BSL_EP026)

Control

Arm Description

Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL_EP026).

Volunteers will take 1 capsule twice daily with maltodextrin.

Outcomes

Primary Outcome Measures

Uric acid
Uric acid in plasma

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2019
Last Updated
May 12, 2020
Sponsor
Biosearch S.A.
Collaborators
Clínica Dr. Miguel Quesada
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1. Study Identification

Unique Protocol Identification Number
NCT04165499
Brief Title
Effect of the Consumption of a Combination of Plant Extracts (BSL_EP026) on Serum Uric Acid.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.
Collaborators
Clínica Dr. Miguel Quesada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
Keywords
Hyperuricemia, Plant extracts

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination of Plant Extracts (BSL_EP026)
Arm Type
Experimental
Arm Description
Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL_EP026).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Volunteers will take 1 capsule twice daily with maltodextrin.
Intervention Type
Combination Product
Intervention Name(s)
Combination of Plant Extracts (BSL_EP026)
Intervention Description
Each participant will consume 2 capsules daily, in the morning and in the evening.
Intervention Type
Combination Product
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo group
Intervention Description
Each participant will consume 2 capsules daily, in the morning and in the evening.
Primary Outcome Measure Information:
Title
Uric acid
Description
Uric acid in plasma
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Uric acid in urine
Description
Uric acid in morning spot urine
Time Frame
2 weeks
Title
pH of urine
Description
pH in morning spot urine
Time Frame
2 weeks
Title
Blood pressure
Description
Systolic and diastolic pressure during the study
Time Frame
2 weeks
Title
Fractional clearance of urate (FCU)
Description
Renal clearance of urate/Renal clearance of creatinine
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Quesada, MD, PhD
Organizational Affiliation
Clínica Dr. Quesada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biosearch Life
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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