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

NCT03512600 | Completed

• 1 other identifier: IB 3475/17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lithiasis, Urinary

Keywords

lithiasis; uric acid; crystallization

Outcome Measures

Primary Outcomes (1)

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

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

  12 hours

Secondary Outcomes (1)

• Concentration of theobromine in urine.

  12 hours

Study Arms (1)

Study group

EXPERIMENTAL

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; Dietary Supplement: Intervention 1; Dietary Supplement: Intervention 2; Dietary Supplement: Intervention 3

Interventions

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).

Also known as: Study group

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.

Also known as: Study group

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.

Also known as: Study Group

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.

Also known as: Study group

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Compliance in participating and collaborating in the study

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Universitat de les Illes Balears, IUNICS

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

MeSH Terms

Conditions

Urolithiasis; Lithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fèlix Grases Freixedas

  Universidad de las Islas Baleares

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: May 1, 2018
• Study Start: September 4, 2017
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)