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

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: Active, not recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Commercial cocoa; Other: High flavonols Cocoa

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Gastrointestinal health	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	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	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

Outcome Measure	Measure Description	Time Frame
Blood pressure	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Vidarium, Nutrition, Health and Wellness Research Center
• Collaborators: CES University; Compañia Nacional de Chocolates
• Investigators: Principal Investigator: Jelver Sierra, PhD, Vidarium, Nutrition, Health and Wellness Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Estimated): December 26, 2024
• Study Completion (Estimated): January 26, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Gut microbiota; Vascular function; Gastrointestinal health; Gut-brain axis; Cocoa flavanols
• Other Study ID 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