Revisions for Cocoa catabolites | Registro Público Cubano de Ensayos Clínicos

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Revision of 1 November 2021 - 9:02am:

Cocoa catabolites

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Determination of the catabolic and absorption profile of cocoa flavanols catabolites generated by the human colonic microbiota.

Secondary indentifying numbers:

21-19-789

Issuing authority of the secondary identifying numbers:

BIOETHICS COMMITTEE UNIVERSITY RESEARCH HEADQUARTERS CBE-SIU. University of Antioquia

Source(s) of monetary or material support:

Compañía Nacional de Chocolates, Vidarium (Nutrition, Health and Wellness Research Center, University CES, MinCiencias

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Katalina

Last name:

Munnoz-Durango

Medical Specialty :

Pharmaceutical Chemist Ph.D Chemical Sciences

Affiliation:

Vidarium, Nutrition, Health and Wellness Research Center

Postal address:

Calle 67 #52-20 Vidarium. Tower B, 3th floor

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+57-2856600 ext. 44565

+57-3006531404

Email address:

kmunoz@serviciosnutresa.com

kmunos@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Colombia

Clinical sites:

Colombia, Hematological Clinical Laboratory of Medellin, Dr. Katalina Muñoz Durango, Specialist in Pharmaceutical Chemistry.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/09/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Not applicable. The aim is to establish the catabolic and absorption profile of cocoa flavanols catabolites generated by the human colonic microbiota.

Health condition(s) code:

Healthy Volunteers

Intervention(s):

The intervention will consist of daily consumption of 20 grams of dark chocolate for five days (5 days). In the beginning, the participant will provide a stool sample (in order to establish the baseline of catabolites for the in vitro model and the baseline sample of the in vivo study), an occasional urine sample from the first hour in the morning, and another 10 hours after the intervention started. At the end of the intervention, you will be asked again for a stool and a urine sample.

Intervention code:

Chocolate

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Catabolites in stool samples (gas chromatography/mass spectrometry; colorimetric methods). Measurement time: baseline and 5 days after chocolate consumption. 2. Catabolites in urine samples (gas chromatography/mass spectrometry; colorimetric methods). Measurement time: baseline (occasional urine first in the morning), 10 hours after the first consumption, and 5 days after the consumption of chocolate. 3. In vitro, microbial catabolism will be evaluated on a fraction of flavanols (gas chromatography/mass spectrometry; colorimetric methods). Measurement time: 0, 3, and 6 hours.

Key secondary outcomes:

Composition of the microbiota (Operational Taxonomic Units, defined to 97% similarity of DNA sequences of variable regions of the 16S rRNA gene). Measurement time: baseline and 5 days after chocolate consumption.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

50 years

Inclusion criteria:

1.Male and female, 2. between 18 and 50 years old, 3. habitual consumers of products derived from cocoa such as chocolate, cocoa, among others. 4. Non-smokers. 5. No diagnosis of gastrointestinal diseases. 6. No consumption of antibiotics, antiparasitic, and/or laxatives in the last three months. 7. Non-vegetarian. 8. Not be enrolled in weight loss programs or consuming weight loss supplements.

Exclusion criteria:

1. Pregnant or breastfeeding women. 2. High-performance athletes.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Other

Other purpose:

To determine the impact of the intestinal microbiota on the degradation of cocoa flavanols and to establish whether these transformed compounds circulate and are eliminated after consumption.

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

8

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Vanessa

Last Name:

Corrales-Agudelo

Specialty:

Dietitian Nutritionist Master in Nutrition and Metabolism, Master in Basic Biomedical Sciences

Affiliation:

Vidarium, Nutrition, Health and Wellness Research Center

Postal Address:

Calle 67 #52-20 Vidarium laboratory. Tower B, 3th floor

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+574 2856600 ext 44566

Email :

vcorrales@serviciosnutresa.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Katalina

Last Name:

Munnoz-Durango

Specialty:

Pharmaceutical Chemist Ph.D Chemical Sciences

Affiliation:

Vidarium, Nutrition, Health and Wellness Research Center

Postal Address:

Calle 67 #52-20 Vidarium. Tower B, 3th floor

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+57-2856600 ext. 44565

Email :

kmunoz@serviciosnutresa.com

kmunos@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Bioethics Committee. University Research Headquarters

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

05/05/2021

Postal address of Ethic Committee :

Building SIU: Street 62 52-59

Telephone:

+57-2196402

Email:

cbioeticasiu@udea.edu.co

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/09/2021

Date of available results:

01/06/2022

Date of first publication:

22/12/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000389

Date of Registration in Primary Registry:

31/08/2021

Record Verification Date:

2021/11/01

Next update date:

2022/11/01

Link to the spanish version:

Click here

Registered Trials

Registration process

Cocoa catabolites

About the RPCEC

Useful resources