Formulación de Productos de panificación Suplementados Con Harina de Porotos Nativos Chilenos Para Disminuir Respuestas glicémicas Postprandiales y agregación Plaquetaria en Personas Mayores: Un Estudio Piloto
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in the postprandial levels of methylglyoxal in plasma
研究概览
简要总结
The goal of this trial is to assess in healthy subjects between 60 and 70 years the effect of glycemic and glycoxidative postprandial responses and platelet aggregation after intake of bread supplemented with Chilean beans flour when compared with a non supplemented control. The main questions to answer are:
- It is possible to decrease postprandial glycemic and glycoxidative responses by means of the intake of bread supplemented with Chilean beans flour when compared to the intake of a control bread non supplemented in healthy elderly persons?
- How is affected the platelet aggregation process during postprandial state after intake of bread supplemented with Chilean beans flour, when compared to the intake of a control bread non supplemented in healthy elderly persons?
Participants will:
- Be characterized by means of: 1) evaluation of body composition, using anthropometric techniques, bioimpedance and 2) biochemical analyses: biochemical profile, lipid profile, serum ferritin, fasting glycemia, HbA1c and insulin.
- Arrive at fast to the laboratory and eat randomly control bread, 30% Chilean beans supplemented bread or glucose. Venous blood samples will be taken from the cubital fossa of the dominant arm at: 0, 30, 60 and 120 min postprandial, only after intake of bread control and supplemented bread. In addition, capillary blood will be taken at 0, 15, 30, 60, 90 and 120 min postprandial after intake of glucose, bread control or supplemented bread.
详细描述
Screening and initial characterization:
Initial screening: General health status will be consulted, and glycemia will be measured at any time, using a hemoglucotest. If eligible (glycemia at any time less than 140 mg/dL), the subjects will be invited to participate in the initial characterization and postprandial study.
Initial characterization:
A medical and nutritional evaluation will be carried out. A medical doctor will ask the volunteers for general information about their state of health and medication consumption.
The nutritional evaluation (weight, height, waist circumference and body composition) will be carried out in the Nutritional Status Evaluation Laboratory of the School of Nutrition and Dietetics of the University of Talca.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Blood samples will be codified, and the keys will be saved by Felipe Ávila. The personal in charge of the blood analyses (quantification of methylglyoxal and 3-deoxyglucosone) will register their results using the codes and therefore will not know the type of sample analyzing or the volunteer that provided the sample.
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons between 60-70 years old.
- •Persons autonomous.
- •Persons who are willing to participate in this study and who have agreed and signed the informed consent.
排除标准
- •Clinical diagnosis of diabetes
- •Persons with levels of glycosylated hemoglobin (HbA1c) lhigher than 6.5
- •Clinical diagnosis and uncontrolled chronic diseases.
- •Anemia, dtermined by ferritin levels less than 15 µg/ L.
- •Oropharyngeal disorders (self-reported).
- •Persons with gastric bypass surgery.
- •Celiac disease (self-reported).
- •Coagulation disorders (self-reported).
- •Use of medications that modify the glycemic response or lipid profile (acarbose, thiazolinediones, metformin, insulin, orlistat, among others).
- •Clinical diagnosis of Alzheimer's disease or sinile dementia.
- •People with pacemakers or metal subcutaneous implants.
结局指标
主要结局
Change in the postprandial levels of methylglyoxal in plasma
时间窗: 0, 30, 60 and 120 min postprandial
Determiantion of the change in the levels of methylglyoxal in plasma by means of pre-column derivatization and posterior separation, detection and quantification by means of high performance liquid chromatography and detection by fluorescence
次要结局
未报告次要终点
研究者
Felipe Ávila Concha
Asociate Professor
University of Talca