Effect of Consuming a Cimarrón Bean Extrudate Solution on Platelet Function and Postprandial Biochemical Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Platelet Reactivity After Acute Consumption of SPVCE
研究概览
简要总结
This non-randomized acute clinical trial evaluates the effect of consuming a water-based solution of Cimarrón bean extrudate on platelet function and postprandial glycemia in adults.
Participants will consume a single 10-gram dose of Cimarrón bean extrudate dissolved in water. Blood samples will be collected before and after the intervention to assess platelet reactivity using flow cytometry and to measure glucose levels through colorimetric spectrophotometry. The total intervention period will last approximately 8 hours. This study aims to explore whether the acute consumption of this legume-based functional product can influence hemostatic and glycemic responses in the postprandial state.
详细描述
This clinical trial aims to evaluate the acute effects of consuming a beverage made from Cimarrón bean extrudate on platelet function and postprandial blood glucose levels in adult participants. The study involves a single-arm, non-randomized, open-label design in which each participant will consume a single oral dose of 10 grams of Cimarrón bean extrudate dissolved in water (SPVCE: Solution Phaseolus vulgaris L var. Cimarrón extrudate)
The trial includes baseline and post-intervention assessments of platelet reactivity using flow cytometry, employing specific agonists (CRP, TRAP, ADP) and labeled antibodies (anti-fibrinogen FITC, PE-CD61/CD62). Blood glucose levels will also be measured at multiple time points using colorimetric spectrophotometry to evaluate postprandial metabolic response.
The total study duration per participant is approximately 8 hours, including fasting baseline measurements, administration of the intervention, and postprandial monitoring. This study seeks to provide preliminary data on the potential hemostatic and glycemic effects of a legume-derived functional food ingredient in a controlled, acute setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary participant
- •Men and women aged 20-59 years
- •Willingness to participate and provide written informend consent
排除标准
- •Documented food allergies, especially ti legumes or beans
- •Diagnosed liver, kidney, , autoinmune diseases or severe illnesses such as cancer.
- •Diagnosed gastrointestinal diseases including inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease, or any condition causing chronic gastrointestinal symptoms such as malabsorption, persistent diarrhea, or gastrointestinal bleeding
- •Use medication known to alter platelet funtion like, antiplatelet agents (aspirin, clopidogrel); Non-steroidal anti-inflamatory drugs (NSAID-Ibuprofen, naproxen); Anticoagulants (Warfarin, heparin, direct oral anticoagulant like rivaroxaban or apixaban); Selective serotonin reuptake inhibitors (SSRIs) and other drugs known to impact platelet aggregation or hemostasis.
研究组 & 干预措施
SPVCE Intervention
Participants will receive a single oral dose of 10 grams of SPVCE. Platelet function (Reactivity and blood risk), postprandial glycemia and Polyphenol concentration will be measured before and after the intervention.
干预措施: SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water) (Dietary Supplement)
结局指标
主要结局
Change in Platelet Reactivity After Acute Consumption of SPVCE
时间窗: Baseline (0 hours) and 6 hours post-intervention
The platelet reactivity was assessed in response to three agonists: ADP, CRP, and TRAP-6. The expression changes of P-selectin and the binding of Fibrinogen to the platelet were measured at baseline (0 hours) and 6 hours. The data were analyzed using dose-response curves and derived metrics of these curves, including basal activity (minimum), maximal response (maximum), EC50, and Capacity of response as the difference between the maximal response and the basal state.
次要结局
- Change in Postprandial Blood Glucose Levels After Consumption of SPVCE(Baseline and up to 2 hours post-intervention)
- Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE(0 minutes (baseline) 2 hour and 6 hours postprandial.)
- Change in Postprandial Platelet Function (Closure Time) After Consumption of SPVCE(Baseline (0 hours) and 6 hour post-intervention.)
研究者
Iván Palomo González
Principal Investigator
University of Talca