HyperuricemiaEarly Phase 1NCT04165499
Effect of the Consumption of a Combination of Plant Extracts (BSL_EP026) on Serum Uric Acid.
A Early Phase 1 study testing Combination of Plant Extracts (BSL_EP026) in people with Hyperuricemia, run by Biosearch S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Combination of Plant Extracts (BSL_EP026)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2019to 20 Mar 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Combination of Plant Extracts (BSL_EP026), Control
- Keywords
- Hyperuricemia, Plant extracts
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Plant Extracts (BSL_EP026)Combination product
Each participant will consume 2 capsules daily, in the morning and in the evening.
ControlCombination product
Also called Placebo group
Each participant will consume 2 capsules daily, in the morning and in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Combination of Plant Extracts (BSL_EP026) | Experimental | Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL_EP026). Receives: Combination Product: Combination of Plant Extracts (BSL_EP026) |
| Control | Placebo comparator | Volunteers will take 1 capsule twice daily with maltodextrin. Receives: Combination Product: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uric acid
Uric acid in plasma
Measured: 2 weeks
Secondary outcomes (4)
Uric acid in urine
Uric acid in morning spot urine
Measured: 2 weeks
pH of urine
pH in morning spot urine
Measured: 2 weeks
Blood pressure
Systolic and diastolic pressure during the study
Measured: 2 weeks
Fractional clearance of urate (FCU)
Renal clearance of urate/Renal clearance of creatinine
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start11 Nov 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clínica Dr. Miguel Quesada
- Responsible party
- Sponsor
- Investigators
- Miguel Quesada, MD, PhD, Principal investigator, Clínica Dr. Quesada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165499
- Sponsor's protocol ID
- C026
- Status last verified
- Jul 2019
- First submitted
- 14 Nov 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04165499
- Acronym / sponsor ID
- C026
- Conditions
- Hyperuricemia
- Keywords
- Hyperuricemia, Plant extracts
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Collaborators
- Clínica Dr. Miguel Quesada
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of Plant Extracts (BSL_EP026) | Experimental | Combination Product: Combination of Plant Extracts (BSL_EP026)Volunteers will take 1 capsule twice daily with the combination of the plant extracts (BSL_EP026). |
| Control | Placebo comparator | Combination Product: ControlVolunteers will take 1 capsule twice daily with maltodextrin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of Plant Extracts (BSL_EP026)Each participant will consume 2 capsules daily, in the morning and in the evening. | Combination product | Combination of Plant Extracts (BSL_EP026) |
| ControlAlso: Placebo groupEach participant will consume 2 capsules daily, in the morning and in the evening. | Combination product | Control |
Primary outcome
Uric acid
Time frame: 2 weeks
Uric acid in plasma
4 secondary outcomes
Uric acid in urine
Time frame: 2 weeks
pH of urine
Time frame: 2 weeks
Blood pressure
Time frame: 2 weeks
Fractional clearance of urate (FCU)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Quesada, MD, PhD principal investigator
Clínica Dr. Quesada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Combination of Plant Extracts (BSL_EP026) in people with Hyperuricemia, run by Biosearch S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uric acid (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.