Clinical trial NCT06513052: Flavanol-rich Cocoa on Digestive and Cerebrovascular Health in the Colombian Adults
Official title: Effect of Consuming Flavanol-rich Cocoa on Biomarkers Associated with Digestive and Cerebrovascular Health in the Colombian Adult Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Keywords: Cocoa flavanols
Gut-brain axis
Gut microbiota
Vascular function
Gastrointestinal health
Lead sponsor: Vidarium, Nutrition, Health and Wellness Research Center
Sponsor class: OTHER
Collaborators: name: CES University
name: Compañia Nacional de Chocolates
First posted: 2024-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Gastrointestinal health
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Gut microbiota composition
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Vascular function
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
Secondary outcomes:
measure: Blood pressure
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Blood lipid profile
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Glucose metabolism
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Markers associated with neuroinflammation
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Markers associated with systemic inflammation
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Markers associated with oxidative stress
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Other markers associated with oxidative stress
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Markers associated with Barrier function
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Markers associated with angiogenesis
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Markers associated with endothelial function
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
measure: Other markers associated with endothelial function
timeFrame: At baseline (time 0) and at the end of the intervention (12 weeks)
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Vidarium, Nutrition, Health and Wellness Research Center
state: Antioquia
Study officials:
affiliation: Vidarium, Nutrition, Health and Wellness Research Center
name: Jelver Sierra, PhD
role: PRINCIPAL_INVESTIGATOR
References: