Effect of Consuming Flavanol-rich Cocoa on Biomarkers Associated with Digestive and Cerebrovascular Health in the Colombian Adult Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Gastrointestinal health
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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)
排除标准
- •Individuals who experience intolerance or adverse effects to the study products during the intervention period will be withdrawn from the trial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).
结局指标
主要结局
Gastrointestinal health
时间窗: 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.
Vascular function
时间窗: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma levels of Endothelin-1 in pg/ml
Gut microbiota composition
时间窗: 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.
次要结局
- Glucose metabolism(At baseline (time 0) and at the end of the intervention (12 weeks))
- Markers associated with oxidative stress(At baseline (time 0) and at the end of the intervention (12 weeks))
- Other markers associated with oxidative stress(At baseline (time 0) and at the end of the intervention (12 weeks))
- Markers associated with Barrier function(At baseline (time 0) and at the end of the intervention (12 weeks))
- Blood pressure(At baseline (time 0) and at the end of the intervention (12 weeks))
- Blood lipid profile(At baseline (time 0) and at the end of the intervention (12 weeks))
- Markers associated with endothelial function(At baseline (time 0) and at the end of the intervention (12 weeks))
- Markers associated with systemic inflammation(At baseline (time 0) and at the end of the intervention (12 weeks))
- Markers associated with neuroinflammation(At baseline (time 0) and at the end of the intervention (12 weeks))
- Markers associated with angiogenesis(At baseline (time 0) and at the end of the intervention (12 weeks))
- Other markers associated with endothelial function(At baseline (time 0) and at the end of the intervention (12 weeks))