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

NCT06513052 | Active Not Recruiting

• 1 other identifier: CF-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Cocoa flavanols; Gut-brain axis; Gut microbiota; Vascular function; Gastrointestinal health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Blood pressure

  At baseline (time 0) and at the end of the intervention (12 weeks)

• Blood lipid profile

  At baseline (time 0) and at the end of the intervention (12 weeks)

• Glucose metabolism

  At baseline (time 0) and at the end of the intervention (12 weeks)

• Markers associated with neuroinflammation

  At baseline (time 0) and at the end of the intervention (12 weeks)

• Markers associated with systemic inflammation

  At baseline (time 0) and at the end of the intervention (12 weeks)

Study Arms (2)

Control

PLACEBO COMPARATOR

\<100 mg cocoa flavanols/day for 12 weeks

Other: Commercial cocoa

Intervention

EXPERIMENTAL

500 mg cocoa flavanols/day for 12 weeks

Other: High flavonols Cocoa

Interventions

Commercial cocoa OTHER

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

Control

High flavonols Cocoa OTHER

Daily intake of a beverage made with 8 grams of cocoa high in flavanols, dissolved in 200 mL of low-fat, lactose-free milk.

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vidarium, Nutrition, Health and Wellness Research Center: lead
• CES University: collaborator
• Compañia Nacional de Chocolates: collaborator

Study Sites (1)

Vidarium, Nutrition, Health and Wellness Research Center

Medellín, Antioquia, 050023, Colombia

Location

Study Officials

• Jelver Sierra, PhD

  Vidarium, Nutrition, Health and Wellness Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 22, 2024
• Study Start: August 5, 2024
• Primary Completion: December 26, 2024
• Study Completion: January 26, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available when the results are published.
• Access Criteria: Public

Locations

CO (1)