Vidarium, Nutrition, Health and Wellness Research Center
Medellín, Antioquia, 050023, Colombia
NCT Number: NCT06513052
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.
This study is active but is not currently recruiting participants.
18 year–70 year
All sexes
Interventional
Not applicable
Medellín, Antioquia, 050023, Colombia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Daily intake of a beverage made with 8 grams of cocoa high in flavanols, dissolved in 200 mL of low-fat, lactose-free milk.
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.
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.
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
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
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.
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in fasting blood glucose levels in mg/dL
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
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
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.
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma oxysterol levels in µg/ml
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.
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
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
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)
Vidarium, Nutrition, Health and Wellness Research Center
Other
Effect of Consuming Flavanol-rich Cocoa on Biomarkers Associated with Digestive and Cerebrovascular Health in the Colombian Adult Population
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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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