NCT06513052

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Vidarium, Nutrition, Health and Wellness Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2024-08-05
• Primary completion: 2024-12-26
• Completion: 2025-01-26
• First posted: 2024-07-22
• Last updated: 2024-10-04

Locations

1 site across 1 country: Colombia