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Active, Not Recruiting

NCT Number: NCT06513052

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vidarium, Nutrition, Health and Wellness Research Center

Medellín, Antioquia, 050023, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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.

Primary outcomes

  1. Gastrointestinal health

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

    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.

  2. Gut microbiota composition

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

    Changes in the Abundance of the beneficial bacteria Bifidobacterium and Lactobacillus, as well as opportunistic pathogens belonging to the Enterobacteriaceae family.

  3. Vascular function

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

    Changes in plasma levels of Endothelin-1 in pg/ml

Secondary outcomes

  1. Blood pressure

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

    Changes in systolic and diastolic blood pressure in mm Hg

  2. Blood lipid profile

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

    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.

  3. Glucose metabolism

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

    Changes in fasting blood glucose levels in mg/dL

  4. Markers associated with neuroinflammation

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

    Changes in plasma levels of interleukin 6 (IL-6) in pg/mL, and tumor necrosis factor alpha (TNF-α) in pg/mL

  5. Markers associated with systemic inflammation

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

    Changes in plasma levels of high sensitivity C reactive protein (hsCRP) in mg/L

  6. Markers associated with oxidative stress

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

    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.

  7. Other markers associated with oxidative stress

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

    Changes in plasma oxysterol levels in µg/ml

  8. Markers associated with Barrier function

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

    Plasma levels of Lipopolysaccharide-binding protein (LBP) in ng/ml, neuron-specific enolase (NSE) in ng/ml and neuregulin-1β in ng/ml.

  9. Markers associated with angiogenesis

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

    Changes in plasma levels of Vascular Endothelial Growth Factor (VEGF) in pg/ml

  10. Markers associated with endothelial function

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

    Changes in plasma levels of endocan in ng/ml, and endostatin in ng/ml

  11. Other markers associated with endothelial function

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

    Changes in plasma levels of nitric oxide (NO) in micromol per liter (µM)

Sponsors and collaborators

Lead sponsor

Vidarium, Nutrition, Health and Wellness Research Center

Other

Collaborators

  • CES University
  • Compañia Nacional de Chocolates

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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