Chronic Effects of Ice Cream Enriched With Cimarrón Bean Extrudate on Metabolic and Cardiovascular Risk Markers: A Randomized Crossover Clinical Trial in Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Serum Glucose
研究概览
简要总结
The goal of this clinical trial is to evaluate the chronic effects of consuming a functional ice cream enriched with Cimarrón bean (Phaseolus vulgaris local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.
The main question it aims to answer is:
- Does chronic daily consumption of the functional ice cream with Cimarrón bean extrudate improve fasting glucose, insulin, lipid profile, and other cardiovascular risk markers?
Researchers will compare a functional ice cream containing 10 g of extrudate per100 g to a placebo version without extrudate, using a crossover design in which participants consume both versions for 4 weeks each, separated by a 3-week washout period to determine metabolic responses.
Participants will:
- Attend clinical visits in fasting conditions at the beginning and end of each 4-week intervention to provide blood samples for glucose, insuli, lipid profile, complete blood count plus Erythrocyte sedimentation rate and HbA1c assessment.
- Undergo anthroprometric measurements and blood pressure assessment at the beginning and end of each 4-week intervention.
- Consume 100g/day of the assigned ice cream during each phase (Two phases)
详细描述
This randomized, single-blind, crossover clinical trial assesses the effects of daily consumption of a functional ice cream enriched with Cimarrón bean extrudate (Phaseolus vulgaris L., local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.
Eligible participants are adults (20-59 years) health or present at least one cardiovascular risk factor (e.g., smoking, insulin resistance, overweight/obesity, hypertension) and a BMI between 18.5 and 39.9 kg/m^2.
Participants are randomized into two groups (Alfa and Gamma) to receive either the placebo or functional ice cream first. Each intervention period lasts 4 week during which participants consume 100 g/day of the assigned ice cream (two 50 g portions, ~2 hours after a main meal). Following a 3-week washout period, participants switch to the alternate intervention. At the beginning and end of each intervention period, anthropometric assessments are performed, including body weight, height, body mass index (BMI), waist circumference, and mid-upper arm circumference. Additionally, fasting blood samples are collected to assess glucose, insulin, lipid profile, complete blood count plus erythrocyte sedimentation rate, HbA1c, and blood pressure.
The placebo or functional ice cream are organoleptically identical to ensure blinding. Randomization is stratified by sex, age, and BMI using balanced block randomization with R software (v4.5.0).
The primary outcomes are the within-subject changes in serum glucose and serum insulin concentrations between the intervention and placebo phases.
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 (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
研究组 & 干预措施
Placebo Ice Cream
Participants consume 100 g/day of placebo ice cream for 4 weeks. The placebo ice cream is organoleptically identical to the intervention but does not contain Cimarrón bean extrudate. After a washout period, participants cross over to the intervention arm.
干预措施: Placebo Ice Cream (Dietary Supplement)
Functional Ice Cream Enriched with Cimarrón Bean Extrudate
Participants consume 100 g/day of ice cream enriched with 10 g of Cimarrón bean extrudate for 4 weeks. After a washout period, participants cross over to the placebo arm.
干预措施: Functional Ice Cream with Cimarrón Bean Extrudate (Dietary Supplement)
结局指标
主要结局
Change in Serum Glucose
时间窗: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Venous blood samples will be collected at the beginning and end of each 4-week intervention phase to measure fasting serum glucose levels. The primary outcome is the within-subject difference in glucose concentration between the placebo and intervention periods. Values will be expressed in mg/dL.
Change in Serum Insulin
时间窗: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Venous blood samples will be collected at the beginning and end of each 4-week intervention phase to measure fasting serum insulin levels. The primary outcome is the within-subject difference in insulin concentration between the placebo and intervention periods. Values will be expressed in µIU/mL.
次要结局
- Change in Total Cholesterol(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in Triglycerides(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in HDL Cholesterol (HDL-c)(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in LDL Cholesterol (LDL-c)(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in Total Cholesterol to HDL-c Ratio(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in Waist Circumference(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in Body Mass Index (BMI)(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in Body Weight(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in Blood Pressure (Systolic and Diastolic)(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
- Change in Arm Circumference(Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period))
研究者
Iván Palomo González
Principal Investigator
University of Talca