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

Vidarium, Nutrition, Health and Wellness Research Center

Status: Active, not recruiting

Conditions: Healthy Volunteers

Treatments: Other: Commercial cocoa; Other: High flavonols Cocoa

Study type: Interventional

Funder types: Other

Identifiers

NCT06513052

CF-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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Individuals who experience intolerance or adverse effects to the study products during the intervention period will be withdrawn from the trial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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

\<100 mg cocoa flavanols/day for 12 weeks

Treatment:

Other: Commercial cocoa

Intervention

Experimental group

Description:

500 mg cocoa flavanols/day for 12 weeks

Treatment:

Other: High flavonols Cocoa