Flavanol-rich Cocoa on Digestive and Cerebrovascular Health in the Colombian Adults

October 2, 2024 updated by: Vidarium, Nutrition, Health and Wellness Research Center

Effect of Consuming Flavanol-rich Cocoa on Biomarkers Associated with Digestive and Cerebrovascular Health in the Colombian Adult Population

The purpose of this study is to investigate the effects of consuming flavanol-rich cocoa on biomarkers associated with digestive and cerebrovascular health in a group of adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study seeks 40 adults aged 20-50 with normal or slightly overweight (by BMI) who regularly consume cocoa/chocolate. After recruitment, participants will receive a detailed explanation of the objectives and conditions of the study and will sign the informed consent and will be randomly assigned to randomly divided into two groups: Control Group that consumes a daily beverage with low-flavanol cocoa or the intervention group that consumes a daily beverage with high-flavanol cocoa. Participants in each intervention arm will be matched by BMI category (normal weight or overweight), sex (female or male), and age (plus or minus 5 years). Both groups will consume a single daily serving (8 grams) of their assigned cocoa (packaged individually) dissolved in low-fat and lactose-free milk (200 ml) before or with their breakfast. At baseline (time 0) and at the end of the intervention (12 weeks), each participant will be assessed for biological indicators gastrointestinal health, the composition of the gut microbiota and cerebrovascular health, markers associated with neuroinflammation, oxidative stress, and barrier function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050023
        • Vidarium, Nutrition, Health and Wellness Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women between 20 and 50 years.
  • Participants should be regular consumers of either table chocolate or cocoa powder
  • Participants should have a BMI within the normal range, which is typically between 18.5 and 24.9 kg/m2. Overweight individuals with a BMI between 25 and 27 kg/m2 may also be eligible. (have a BMI within the normal or slightly overweight range)

Exclusion Criteria:

  • Individuals who experience intolerance or adverse effects to the study products during the intervention period will be withdrawn from the trial
  • Participants who become pregnant during the study will be excluded.
  • Individuals who are diagnosed with Gastrointestinal diseases: This includes liver disorders, duodenal ulcers, gastritis, malabsorption disorders, short bowel syndrome, diverticulosis, Crohn's disease, ulcerative colitis, irritable bowel syndrome, and celiac disease. Central nervous system diseases: This includes vascular dementia and other neurodegenerative diseases. Inflammatory diseases, Malignant neoplasms, Diabetes mellitus, Cardiovascular diseases and Recent fractures.
  • Significant alcohol consumption: Participants who consume more than 1 alcoholic drink per day for women or 2 alcoholic drinks per day for men.
  • High coffee consumption: Participants who consume more than 2 cups of coffee per day will be excluded.
  • Regular use of certain medications: Participants who regularly consume (within the past 3 months) any of the following medications: Metformin, Steroid anti-inflammatory drugs (NSAIDs) like dexamethasone, prednisone, triamcinolone, prednisolone, betamethasone, hydrocortisone, deflazacort, paramethasone, and fludrocortisone. Proton pump inhibitors (PPIs) like omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, and dexlansoprazole. Hypnotic medications: These include drugs like zolpidem, zaleplon, alprazolam, diazepam, lorazepam, midazolam, and flurazepam. Antibiotics, antiparasitics, or laxatives. Medications containing acetylsalicylic acid (aspirin) or 5-alpha reductase inhibitors (finasteride, dutasteride).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
<100 mg cocoa flavanols/day for 12 weeks
Other: Commercial cocoa
daily intake of a beverage made with 8 grams of commercial cocoa low in flavanols, dissolved in 200 mL of low-fat, lactose-free milk
Experimental: Intervention
500 mg cocoa flavanols/day for 12 weeks
Other: High flavonols Cocoa
Daily intake of a beverage made with 8 grams of cocoa high in flavanols, dissolved in 200 mL of low-fat, lactose-free milk.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal health
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in Gastrointestinal Symptom Assessment Scale (GSRS) scores. The GSRS is a 7-point scale ranging from 1 (no discomfort at all) to 7 (severe discomfort), with higher scores indicating worse gastrointestinal symptoms.
At baseline (time 0) and at the end of the intervention (12 weeks)
Gut microbiota composition
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in the Abundance of the beneficial bacteria Bifidobacterium and Lactobacillus, as well as opportunistic pathogens belonging to the Enterobacteriaceae family.
At baseline (time 0) and at the end of the intervention (12 weeks)
Vascular function
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma levels of Endothelin-1 in pg/ml
At baseline (time 0) and at the end of the intervention (12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in systolic and diastolic blood pressure in mm Hg
At baseline (time 0) and at the end of the intervention (12 weeks)
Blood lipid profile
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in serum levels of total cholesterol in mg/dL, LDL cholesterol in mg/dL, HDL cholesterol in mg/dL and triglycerides in mg/dL.
At baseline (time 0) and at the end of the intervention (12 weeks)
Glucose metabolism
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in fasting blood glucose levels in mg/dL
At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with neuroinflammation
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma levels of interleukin 6 (IL-6) in pg/mL, and tumor necrosis factor alpha (TNF-α) in pg/mL
At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with systemic inflammation
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma levels of high sensitivity C reactive protein (hsCRP) in mg/L
At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with oxidative stress
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)

Changes in urine levels of 8-isoprostane corrected for creatinine clearance (ng/mg creatinine).

Corrected urine 8-isoprostane levels will be calculated by dividing urine 8-isoprostane levels in ng/ml by urine creatinine levels in mg/ml.
At baseline (time 0) and at the end of the intervention (12 weeks)
Other markers associated with oxidative stress
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma oxysterol levels in µg/ml
At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with Barrier function
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Plasma levels of Lipopolysaccharide-binding protein (LBP) in ng/ml, neuron-specific enolase (NSE) in ng/ml and neuregulin-1β in ng/ml.
At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with angiogenesis
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma levels of Vascular Endothelial Growth Factor (VEGF) in pg/ml
At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with endothelial function
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma levels of endocan in ng/ml, and endostatin in ng/ml
At baseline (time 0) and at the end of the intervention (12 weeks)
Other markers associated with endothelial function
Time Frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma levels of nitric oxide (NO) in micromol per liter (µM)
At baseline (time 0) and at the end of the intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vidarium, Nutrition, Health and Wellness Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CES University
Compañia Nacional de Chocolates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jelver Sierra, PhD, Vidarium, Nutrition, Health and Wellness Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CF-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available when the results are published. The data can be obtained by downloading from the cloud (ex: Sequence Read Archive data at National center for biotechnology information (NCBI-SRA) or GitHub)

IPD Sharing Time Frame

Data will be available when the results are published.

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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