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Trial record 43 of 1615 for:    Recruiting, Not yet recruiting, Available Studies | dietary supplements

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

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ClinicalTrials.gov Identifier: NCT03483532
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Devicare S.L.

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.


Condition or disease Intervention/treatment
Lithiasis Dietary Supplement: Lit Control pH Up Dietary Supplement: dry cocoa extract

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Study of the Crystallization Inhibition Capacity of the Uric Acid in Urine in a Group of Lithiasic Patients After Intake of a Food Supplement. PEv2
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

Group/Cohort Intervention/treatment
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
dietary supplement based on citrate, saponins, magnesium, zinc and vitamin A

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




Primary Outcome Measures :
  1. Inhibition of the crystallization of uric acid [ Time Frame: 12 hours ]
    Capacity of inhibition of the crystallization of uric acid in the first morning urine


Secondary Outcome Measures :
  1. Uric Acid [ Time Frame: 12 hours ]
    Uric Acid in Urine, measured in mg/L

  2. Creatine [ Time Frame: 12 hours ]
    Creatine in urin, measured in mg/L

  3. Oxalate [ Time Frame: 12 hours ]
    mg/L

  4. Teobromine [ Time Frame: 12 hours ]
    Teobromine in urine, measured in mg/L

  5. Urine Volume [ Time Frame: 12 hours ]
    Measured in ml

  6. pH [ Time Frame: 12 hours ]
    Urine ph


Biospecimen Retention:   Samples Without DNA
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483532


Contacts
Contact: Yumaira Elena Hernández Martínez 658666975 yumairah@yahoo.com
Contact: Jordi Cuñé Castellana 686888676 jcune@devicare.com

Locations
Spain
Hospital de Manacor Recruiting
Manacor, Islas Baleares, Spain, 07500
Contact: Yumaira Elena Hernández Martínez    658666975    yumairah@yahoo.com   
Sponsors and Collaborators
Devicare S.L.
Investigators
Study Director: Jordi Cuñé Castellana Devicare S.L.

Responsible Party: Devicare S.L.
ClinicalTrials.gov Identifier: NCT03483532     History of Changes
Other Study ID Numbers: IB 3414/17
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Devicare S.L.:
lithiasis
uric acid
crystallization

Additional relevant MeSH terms:
Lithiasis
Pathologic Processes
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs