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Completed

NCT Number: NCT04165499

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Biosearch Life

Granada, Andalusia, 18004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination of Plant Extracts (BSL_EP026)

Combination Product

Each participant will consume 2 capsules daily, in the morning and in the evening.

Control

Combination Product

Each participant will consume 2 capsules daily, in the morning and in the evening.

Other names: Placebo group

Primary outcomes

  1. Uric acid

    Time frame: 2 weeks

    Uric acid in plasma

Secondary outcomes

  1. Uric acid in urine

    Time frame: 2 weeks

    Uric acid in morning spot urine

  2. pH of urine

    Time frame: 2 weeks

    pH in morning spot urine

  3. Blood pressure

    Time frame: 2 weeks

    Systolic and diastolic pressure during the study

  4. Fractional clearance of urate (FCU)

    Time frame: 2 weeks

    Renal clearance of urate/Renal clearance of creatinine

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Collaborators

  • Clínica Dr. Miguel Quesada

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2019
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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