Status:
ACTIVE_NOT_RECRUITING
Flavanol-rich Cocoa on Digestive and Cerebrovascular Health in the Colombian Adults
Lead Sponsor:
Vidarium, Nutrition, Health and Wellness Research Center
Collaborating Sponsors:
CES University
Compañia Nacional de Chocolates
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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.
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 objec...
Eligibility Criteria
Inclusion
- 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
- Individuals who experience intolerance or adverse effects to the study products during the intervention period will be withdrawn from the trial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).
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 26 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06513052
Start Date
August 5 2024
End Date
January 26 2025
Last Update
October 4 2024
Active Locations (1)
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1
Vidarium, Nutrition, Health and Wellness Research Center
Medellín, Antioquia, Colombia, 050023