Study of the Crystallization Inhibition Capacity of the Uric Acid in Urine in a Group of Lithiasic Patients After Intake of a Food Supplement

Summary

Renal lithiasis affects a wide range of the population, ranging from 4 to 15% according to the population sample studied. Among all stones, it is estimated that uric stones account for between 10 and 15% of all cases and especially affects men over 50 years, while mixed lithiasis of calcium oxalate monohydrate and uric acid affects a 2.5% of all cases. Lithiasis generated by uric acid is a highly recurrent pathology, even repeating itself several times during the year, and is related to other pathologies such as diabetes and obesity. It is evident that the medical problem that lithiasis originates should not be treated only by eliminating the calculus formed, through the different surgical techniques available, but also that the alterations responsible for its formation should be modified and corrected. If these alterations are not modified, the risk of the genesis of new calculations persists.

The pharmacological treatments used until now to treat uric lithiasis are based on the powerful alkalinization of the urine (through the use of citrate or bicarbonate); These treatments tend to have a low rate of adherence and, taken long term, can cause the development of stones of another composition (eg, Phosphate), which are much more difficult to treat.

There are natural substances, such as theobromine (natural component of cocoa) that has been found to have the ability to inhibit the formation of uric acid crystals: this substance has been tested in laboratory experiments and therefore would be useful to prevent the formation of uric acid stones and / or mixed calcium oxalate monohydrate / uric acid stones. Theobromine corresponds to a phytocomponent alkaloid that is found in high concentrations in chocolate. The starting hypothesis of this study corresponds to the possible increase in the capacity of inhibition of the crystallization of uric acid by urine in subjects who have ingested food or food supplements containing cocoa or cocoa extract. Therefore, the relationship between the intake of a specific food supplement and the ability to inhibit the crystallization of uric acid by the urine will be studied. An increase in the ability to inhibit the crystallization of uric acid from urine would be useful to prevent the formation of uric acid crystals in urine, which are the origin of uric acid stones or mixed calcium oxalate monohydrate / acid uric.

Currently there is no information on the relationship between the ability to inhibit the crystallization of uric acid in the urine due to the intake of certain foods or food supplements and the concentration of theobromine in urine and urinary pH. The present study is carried out to evaluate the relationship between the intake of a specific food supplement and the ability to inhibit the crystallization of uric acid by urine, which would be useful to prevent the formation of uric acid stones and / or mixed calculations of calcium oxalate monohydrate / uric acid.

The study will be carried out in two stages. The first will consist in the intake of 1 capsule of a food supplement based on citrate and plant extract without cocoa extract, twice a day for 14 days. The second will consist in the intake of 1 capsule of a food supplement based on citrate and plant extract with cocoa extract, twice a day for 14 days. Before the start of the study a blood sample will be obtained and on the last day of each stage, the patient will be asked to collect the 24-hour urine and another 2-hour morning urine sample. Between each stage will be a period of 7 days without receiving any food supplement.

During the study there will be no risk due to the tests that will be performed, since they are among those performed in routine clinical practice. Regarding the possible risks associated with the intake of food supplement, to minimize them, any patient with chocolate or theobromine allergy, pregnant or lactating women and patients with insufficiency are excluded from the study participation. chronic kidney The daily amount of theobromine ingested as cocoa extract is similar to a quantity of dark chocolate between 11-25 g. This consumption of chocolate can be considered normal within a diet. In fact a piece of 50 g of dark chocolate contains between 237 and 519 mg of theobromine and daily many people consume more of this amount without presenting side effects to be a food.

Conditions

• Lithiasis

Interventions

DIETARY_SUPPLEMENT

Lit Control pH Up

dietary supplement based on citrate, saponins, magnesium, zinc and vitamin A

DIETARY_SUPPLEMENT

dry cocoa extract

(Theobroma cacao, fruit), 2 capsules of 750 mg per individual, dosed at a rate of one during the breakfast and another during dinner.

Sponsors & Collaborators

• Universidad de las Islas Baleares

  collaborator UNKNOWN

• Devicare S.L.

  lead INDUSTRY

Principal Investigators

• Fèlix Grases Freixedas · Universidad de las Islas Baleares

• Yumaira Elena Hernández Martínez · Hospital de Manacor

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-06

Primary Completion

2019-12-02

Completion

2019-12-02

Countries

• Spain

Study Locations