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.
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Nov 2019
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2019
CompletedFirst Submitted
Initial submission to the registry
November 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2020
CompletedMay 13, 2020
July 1, 2019
4 months
November 14, 2019
May 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Uric acid
Uric acid in plasma
2 weeks
Secondary Outcomes (4)
Uric acid in urine
2 weeks
pH of urine
2 weeks
Blood pressure
2 weeks
Fractional clearance of urate (FCU)
2 weeks
Study Arms (2)
Combination of Plant Extracts (BSL_EP026)
EXPERIMENTALVolunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL\_EP026).
Control
PLACEBO COMPARATORVolunteers will take 1 capsule twice daily with maltodextrin.
Interventions
Each participant will consume 2 capsules daily, in the morning and in the evening.
Each participant will consume 2 capsules daily, in the morning and in the evening.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biosearch S.A.lead
- Clínica Dr. Miguel Quesadacollaborator
Study Sites (1)
Biosearch Life
Granada, Andalusia, 18004, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel Quesada, MD, PhD
Clínica Dr. Quesada
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2019
First Posted
November 18, 2019
Study Start
November 11, 2019
Primary Completion
March 20, 2020
Study Completion
March 20, 2020
Last Updated
May 13, 2020
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share