Skip to main content
OpenTrials
Completed

NCT Number: NCT03512600

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat de les Illes Balears, IUNICS

Palma de Mallorca, Balearic Islands, 07122, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, ...)

Treatment and study plan

Intervention 0

Dietary Supplement

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 names: Study group

Intervention 1

Dietary Supplement

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 names: Study group

Intervention 2

Dietary Supplement

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 names: Study Group

Intervention 3

Dietary Supplement

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 names: Study group

Primary outcomes

  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 outcomes

  1. Concentration of theobromine in urine.

    Time frame: 12 hours

    Concentration of theobromine in urine.

Sponsors and collaborators

Lead sponsor

Devicare S.L.

Industry

Collaborators

  • Universidad de las Islas Baleares

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 1, 2018
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.