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

NCT03483532 | Completed

• 1 other identifier: IB 3414/17
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lithiasis; uric acid; crystallization

Outcome Measures

Primary Outcomes (1)

• Inhibition of the crystallization of uric acid

  Capacity of inhibition of the crystallization of uric acid in the first morning urine

  12 hours

Secondary Outcomes (6)

• Uric Acid

  12 hours

• Creatine

  12 hours

• Oxalate

  12 hours

• Teobromine

  12 hours

• Urine Volume

  12 hours

Study Arms (2)

Lit Control pH Up without cocoa extract

The nutritional exposure will consist in the intake of 1 capsule of the food supplement based on citrate and plant extract without cocoa extract dosed at the rate of one during breakfast and another during dinner, during a period of 14 days to a group of 30 patients.

Dietary Supplement: Lit Control pH Up

Lit Control pH Up with dry cocoa extract

The nutritional exposure will consist in the intake of 1 capsule of the food supplement based on citrate and plant extract with cocoa extract dosed at the rate of one during breakfast and another during dinner, during a period of 14 days to a group of 30 patients.

Dietary Supplement: dry cocoa extract

Interventions

Lit Control pH Up DIETARY_SUPPLEMENT

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

Lit Control pH Up without cocoa extract

dry cocoa extract DIETARY_SUPPLEMENT

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

Lit Control pH Up with dry cocoa extract

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The number of patients will be 60 (see the justification for the number of patients in the section Study sample). This intervention will be carried out in a sample of patients with uric lithiasis or urinary COM / Ac uric acid, as it is a sample of patients available. This corresponds to a preliminary study and its use does not allows a direct extrapolation of the data obtained to the general population. This available sample will be described sufficiently to be able to make a cautious extrapolation to the population that could be represented by that sample. The studies with these population samples are the ones that are used to make specific studies on the same samples and to carry out studies experimental with few subjects as is this case.

You may qualify if:

• You are over 18 and less than 75 years old
• You have presented a previous episode of objectifiable uric lithiasis
• Presents normouricemia
• Possesses the results of laboratory tests (biochemistry and urine)
• The patient agrees to participate and collaborate in the study

You may not qualify if:

• Active urinary infection
• Allergy to chocolate or theobromine
• Serum creatinine greater than 1.5 mg / dl
• Pregnancy, lactation period (women)
• Intestinal obstruction
• Hyperuricemia
• Treatment with diuretics
• Treatment with allopurinol or febuxostat.
• Congestive heart failure
• Other pharmacological treatments for the prevention of hyperuricemia
• Chronic renal failure

Sponsors & Collaborators

• Devicare S.L.: lead
• Universidad de las Islas Baleares: collaborator

Study Sites (1)

Hospital de Manacor

Manacor, Balearic Islands, 07500, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Lithiasis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fèlix Grases Freixedas

  Universidad de las Islas Baleares

  PRINCIPAL INVESTIGATOR

• Yumaira Elena Hernández Martínez

  Hospital de Manacor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: March 30, 2018
• Study Start: September 6, 2017
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

ES (1)