Effects of Acute Consumption of Ice Cream Enriched With Cimarron Bean Extruded on Metabolic Responses in Adults: A Non-Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Postprandial Glucose Concentration
研究概览
简要总结
The goal of this non-randomized clinical trial is to evaluate the acute postprandial metabolic effects of a functional ice cream enriched with Cimarrón bean (Phaseolus vulgaris L. local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.
The main questions it aims to answer are:
- Does the functional ice cream reduce postprandial glucose and insulin levels?
- Does it affect postprandial lipid concentrations?
Researchers will compare participants receiving a single dose of the functional ice cream containing 10 g of extrudate per 100 g to placebo version without extrudate, both ice creams are identical in appearance and taste.
Participants will:
- Attend a clinical visit in fasting conditions (10-12 hours).
- Provide baseline blood samples for glucose, insulin, and lipid profile.
- Consume a single 100 g portion of functional or placebo ice cream.
- Provide postprandial blood samples at defined time points.
详细描述
This Study trial is to evaluate the acute postprandial metabolic effects of a functional ice cream with Cimarrón bean (Phaseolus vulgaris L. local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.
It is a non-randomized, single-blind, parallel-group clinical trial with two arms: intervention (functional ice cream) and control (placebo ice cream). Both products are matched for texture, flavor, and appearance to maintain participant blinding.
Participants arrive at the clinic after a 10-12 hour fast. Baseline blood samples are collected for glucose, insulin, and lipid profile. They then consume one 100 g portion of the assigned ice cream. Blood samples are collected postprandially at 120 minutes to assess changes in glucose, insulin and lipid profile.
The study aims to determine whether the functional ice cream modifies postprandial glycemic and lipemic responses, providing insight into its potential use as a dietary strategy to reduce cardiometabolic risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants were blinded to the intervention type (placebo vs. functional ice cream) by providing both ice creams with identical appearance, texture, and flavor.
The investigators were not blinded due to the need to manage logistics and sample handling. However, participants were unaware of their group assignment to minimize bias in self-reported adherence and perception of effects.
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 informed consent
排除标准
- •Documented food allergies, especially to legumes or beans
- •Diagnosed liver, kidney, autoimmune 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
结局指标
主要结局
Change in Postprandial Glucose Concentration
时间窗: Baseline and 120 minutes after consumption
Blood glucose levels will be measured at fasting (baseline) and at 120 minutes following the intake of either functional or placebo ice cream. Outcome will be expressed in mg/dL.
Change in Postprandial Insulin Concentration
时间窗: Baseline and 120 minutes after consumption
Blood insulin levels will be assessed at fasting and at 120 minutes post-consumption. Outcome will be expressed in µIU/mL.
Change in Postprandial Glucose Concentration
时间窗: Baseline and 120 minutes after consumption
Blood glucose levels will be measured at fasting (baseline) and at 120 minutes following the intake of either functional or placebo ice cream. Outcome will be expressed in mg/dL.
Change in Postprandial Insulin Concentration
时间窗: Baseline and 120 minutes after consumption
Blood insulin levels will be assessed at fasting and at 120 minutes post-consumption. Outcome will be expressed in µIU/mL.
次要结局
- Change in Postprandial Lipid Profile(Baseline and 120 minutes after consumption.)
- Change in Postprandial Lipid Profile(Baseline and 120 minutes after consumption.)
研究者
Iván Palomo González
Principal Investigator
University of Talca