Flavanol-rich Cocoa on Digestive and Cerebrovascular Health in the Colombian Adults
NCT Number: NCT06513052
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Volunteers
Interventions: OTHER: Commercial cocoa|OTHER: High flavonols Cocoa
Sponsor: Vidarium, Nutrition, Health and Wellness Research Center
Collaborators: CES University|Compañia Nacional de Chocolates
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-12
Completion Date: 2025-01-26
Locations: Vidarium, Nutrition, Health and Wellness Research Center, Medellin, Antioquia, 050023, Colombia

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.

Primary Outcome Measures: 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: 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)