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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
40
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.
Vidarium, Nutrition, Health and Wellness Research Center
Medellín, Antioquia, Colombia
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.
Time frame: 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.
Time frame: 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
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Blood pressure
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)
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.
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Glucose metabolism
Changes in fasting blood glucose levels in mg/dL
Time frame: 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
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Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)