The Effects of a Fiber-enriched Bakery Product on Glucose, Insulin Values and Appetite. A Pilot Randomized Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in circulating concentrations of glucose
研究概览
简要总结
The aim of the present pilot randomized controlled trial is to compare the effects of the following: 1)-panettone enriched with arabinoxylans (p-rich), 2)-panettone not enriched (p-standard) on blood glucose and insulin values, and appetite scores in 10 healthy volunteers.
详细描述
This is a crossover, randomized double-blind trial. A product enriched with arabinoxylan extracted from threshing (panettone, p-rich, a sweet baked product with a high glycemic index) was developed to assess the impact on metabolic responses and satiety when compared to the standard product (p-standard) .
Ten Caucasian non-smoker healthy adult volunteers were enrolled starting from January 2023.
Participants were randomized to receive either the p-rich or p-standard. The order of administration of each product was randomized using a computer-generated sequence. The day of each test, fasting individuals underwent a blood sample collection, and weight and height measurements. Then, participants consumed 100 grams of the product within 20 minutes, while sitting. Blood samples were collected at 15, 30, 45, 60, 90, 120 minutes after the consumption of each food.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Neither the participant nor the investigators were aware of the composition of the administered food. The two types of foods were identical for packages, color, flavor, smell, and appearance. Furthermore, the researchers who analyzed data and the laboratory personnel who performed the biochemical analyses were blinded to the group assigned.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-smokers healthy adults;
- •age 20-65 years;
- •ability to provide informed written consent
排除标准
- •chronic diseases or pharmacological therapies;
- •dietary restrictions;
- •allergy or intolerance to the tested food
结局指标
主要结局
Changes in circulating concentrations of glucose
时间窗: 15, 30, 45, 60, 90, 120 minutes after the consumption of each food
To evaluate changes in glucose responses after the consumption of p-rich when compared to p-standard
次要结局
- Changes in circulating concentrations of insulin(15, 30, 45, 60, 90, 120 minutes after the consumption of each food)
- Changes in subjective appetite score (VAS)(60, 120, 180, and 240 minutes after the consumption of each food)
研究者
Simona Bo
Associate Professor
University of Turin, Italy