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Study of the Effects of the Consumption of Different Products Cocoa Derivatives at the Risk of Crystallization of Uric Acid in Urine of Volunteers.

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ClinicalTrials.gov Identifier: NCT03512600
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Devicare S.L.

Brief Summary:
The present study aims to assess the effectiveness of theobromine, -product present in high proportion in the cacao-, to prevent the development of uric acid kidney stones.

Condition or disease Intervention/treatment Phase
Lithiasis, Urinary Dietary Supplement: Intervention 0 Dietary Supplement: Intervention 1 Dietary Supplement: Intervention 2 Dietary Supplement: Intervention 3 Not Applicable

Detailed Description:

Renal lithiasis is a pathology that affects a high percentage of the population, and although it has been known for a long time, advances carried out in the treatment are limited to the surgical aspects, while the causes responsible for the formation of kidney calculus are not corrected, which leads to a high recurrence.

The "healing" of renal lithiasis inevitably goes through the elimination of the alterations related to the genesis of kidney calculus. It the case of uric acid lithiasis the most important are having urinary pH less than 5.5 and an elevated uricosuria, which can be corrected relatively easy by undergoing changes in dietary habits, and with pharmacological treatment with citrate -which produces and increase in pH- or with inhibitors of the xantino-oxidase as allopurinol. However, among the prophylactic treatments available for ural acid lithiasis, so far it does not exist one for urinary acid crystallization inhibition.

Recently, the effects of theobromine as an inhibitor of the crystallization of uric acid have been described, but only in vitro. The present study aims to assess the effectiveness of theobromine, -product present in high proportion in the cacao-, to prevent the development of uric acid kidney stones.

The study is a unicentric, low intervention, non-randomized, prospective study to assess the effects of the consumption of different cocoa derivate products, in the risk of crystallization of uric acid in the urine. Participants in the study are healthy volunteers and will it will be carried out with 20 individuals who will be recruited in the Research Laboratory in Renal Lithiasis of the Baleares Isles University.

Patients will take a urine test previously to undergo 4 dietary interventions, with their subsequent urine measurements. Patients will choose one diet to follow for 1 day, and will be provided with the corresponding cocoa derivate for the diet (soluble cocoa, black chocolate, chocolate with milk). The day after the diet they will take a fast-picking of urine accumulated during the night of which they followed the controlled diet (12 h nocturne sample), then follow a 6 day washout period, and select another diet to follow and repeat until they have gone through the 4 diets and measurements.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of the Effects of the Consumption of Different Products Cocoa Derivatives at the Risk of Crystallization of Uric Acid in Urine of Volunteers.
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : October 6, 2017
Actual Study Completion Date : October 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

Arm Intervention/treatment
Experimental: Study group

All patients will follow four different dietary interventions (with or without cacao) for 1 day prior to the taking of a urine sample.

After the sample is taken the patient will follow a washout period of 6 days before following a different diet and this process will be repeated for each patient until they have followed the four diets.

.

Dietary Supplement: Intervention 0
Without nutritional intervention, it will consist of normal food intake without food derived from cocoa or coffee for a period of 1 day in the group of 20 patients during meals. ( That day the patient can not consume cocoa derivates nor coffe or coffe derivates).
Other Name: Study group

Dietary Supplement: Intervention 1

The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cocoa that will be provided to the paient (Food based on soluble cocoa) during one 1 day period in the group of 20 patients during meals.

That day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided.

Other Name: Study group

Dietary Supplement: Intervention 2

The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cacao (Food based on black chocolate) during a period of 1 day in the group of 20 patients during meals.

That day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided.

Other Name: Study Group

Dietary Supplement: Intervention 3

The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cocoa (Food based on chocolate with milk) for a period of 1 day in the group of 20 patients during meals.

That day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided.

Other Name: Study group




Primary Outcome Measures :
  1. Ability to inhibit the crystallization of uric acid in urine collected. [ Time Frame: 12 hours ]
    Ability to inhibit the crystallization of uric acid in urine collected.


Secondary Outcome Measures :
  1. Concentration of theobromine in urine. [ Time Frame: 12 hours ]
    Concentration of theobromine in 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:   Yes
Criteria

Inclusion Criteria:

  • Compliance in participating and collaborating in the study

Exclusion Criteria:

  • Cocoa / chocolate allergy or theobromine
  • Pregnancy, nursing period (women)
  • pharmacological treatment
  • chronic diseases (diabetes, kidney failure, heart failure, hyperuricemia, ...)

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): NCT03512600


Locations
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Spain
Universitat de les Illes Balears, IUNICS
Palma De Mallorca, Islas Baleares, Spain, 07122
Sponsors and Collaborators
Devicare S.L.
Investigators
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Study Director: Jordi Cuñé Castellana Devicare S.L.

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Responsible Party: Devicare S.L.
ClinicalTrials.gov Identifier: NCT03512600     History of Changes
Other Study ID Numbers: IB 3475/17
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Urolithiasis
Lithiasis
Pathologic Processes
Urologic Diseases
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs