Effects of an Arabinoxylan-enriched Rusk on Postprandial Glucose, Insulin, Glucagon-like Peptide-1 and Appetite Responses: 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
- 1
- 主要终点
- Change in circulating blood glucose concentration (metabolic variables) [mg/dL]
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)-rusk enriched with arabinoxylans (r-rich), 2)-rusk not enriched (r-standard) on blood glucose, insulin values, glucagon like peptide (GLP-1) and appetite scores in 10 healthy volunteers.
详细描述
This is a double-blind, randomized crossover trial. A rusk product enriched with arabinoxylan extracted from threshing residues, hereafter referred to as r-rich, was developed to evaluate its effects on postprandial metabolic responses and satiety compared with the standard product, referred to as r-standard. Ten healthy adult Caucasian non-smoker volunteers were enrolled starting from October 2025. Participants received both products in a computer-generated randomized sequence, with a washout period of at least 72 hours between test sessions. On each test day, after an overnight fast, participants underwent baseline blood sample collection and anthropometric measurements, including body weight and height. They then consumed 100 g of the assigned product within 20 minutes while seated. Blood samples were collected at 20, 60, 90, 120 and 180 minutes after product consumption.
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
- •healthy adults;
- •age 20-65 years;
- •ability to provide informed written consent.
排除标准
- •acute or chronic diseases;
- •pharmacological therapies or supplements potentially influencing glycemic and/or insulinemic responses;
- •dietary restrictions;
- •allergy or intolerance to the tested food
结局指标
主要结局
Change in circulating blood glucose concentration (metabolic variables) [mg/dL]
时间窗: 20, 60, 90, 120, and 180 minutes after the consumption of each food.
Evaluation of changes in glucose responses after the consumption of r-rich when compared to r-standard. The unit of measure for glucose concentration is milligrams per deciliter (mg/dL).
Change in circulating serum insulin levels (metabolic variables) [mIU/ml]
时间窗: 20, 60, 90, 120 and 180 minutes after the consumption of each food.
Evaluation of changes in insulin responses after the consumption of r-rich when compared to r-standard. The unit of measure for insulin is milli-international units per milliliter (mIU/ml).
Change in circulating glucagon-like peptide-1 (GLP-1) concentration [pg/ml]
时间窗: 20, 60, 90, 120 and 180 minutes after consumption of each food.
Evaluation of changes in GLP-1 responses after the consumption of r-rich when compared to r-standard. The unit of measure for GLP-1 is picograms per milliliter (pg/mL).
次要结局
- Postprandial Subjective Satiety Perception(60, 120, 180, and 240 minutes post-consumption.)
- Postprandial Hunger(60, 120, 180, and 240 minutes post-consumption.)
- Postprandial Gastric Fullness(60, 120, 180, and 240 minutes post-consumption.)
- Prospective Food Consumption(60, 120, 180, and 240 minutes post-consumption.)
- Gastrointestinal Symptoms Evaluation(Within 24 hours after rusk intake.)
研究者
Simona Bo
Associate Professor
University of Turin, Italy