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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.

Primary Purpose

Lithiasis, Urinary

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention 0
Intervention 1
Intervention 2
Intervention 3
Sponsored by
Devicare S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lithiasis, Urinary focused on measuring lithiasis, uric acid, crystallization

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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, ...)

Sites / Locations

  • Universitat de les Illes Balears, IUNICS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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. .

Outcomes

Primary Outcome Measures

Ability to inhibit the crystallization of uric acid in urine collected.
Ability to inhibit the crystallization of uric acid in urine collected.

Secondary Outcome Measures

Concentration of theobromine in urine.
Concentration of theobromine in urine.

Full Information

First Posted
March 23, 2018
Last Updated
July 21, 2020
Sponsor
Devicare S.L.
Collaborators
Universidad de las Islas Baleares
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1. Study Identification

Unique Protocol Identification Number
NCT03512600
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
October 6, 2017 (Actual)
Study Completion Date
October 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Devicare S.L.
Collaborators
Universidad de las Islas Baleares

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lithiasis, Urinary
Keywords
lithiasis, uric acid, crystallization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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. .
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention 0
Other Intervention Name(s)
Study group
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention 1
Other Intervention Name(s)
Study group
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention 2
Other Intervention Name(s)
Study Group
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention 3
Other Intervention Name(s)
Study group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability to inhibit the crystallization of uric acid in urine collected.
Description
Ability to inhibit the crystallization of uric acid in urine collected.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Concentration of theobromine in urine.
Description
Concentration of theobromine in urine.
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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, ...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fèlix Grases Freixedas
Organizational Affiliation
Universidad de las Islas Baleares
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat de les Illes Balears, IUNICS
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07122
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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