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| Name | Class |
|---|---|
| CES University | OTHER |
| Compañia Nacional de Chocolates | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | <100 mg cocoa flavanols/day for 12 weeks |
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| Intervention | Experimental | 500 mg cocoa flavanols/day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jelver Sierra, PhD | Vidarium, Nutrition, Health and Wellness Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vidarium, Nutrition, Health and Wellness Research Center | Medellín | Antioquia | 050023 | Colombia |
The data will be available when the results are published. The data can be obtained by downloading from the cloud (ex: Sequence Read Archive data at National center for biotechnology information (NCBI-SRA) or GitHub)
Data will be available when the results are published.
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| 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. |
|
| 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) |