Glucosidase Inhibitors and Glucose Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Post-prandial glucose response
研究概览
简要总结
The purpose of this study is to determine whether continuous glucose monitoring is sensitive to quantifying the glucose response related to consumption of a starchy vegetable (potato) in combination with or separate from consumption of herbs and spices at the same meal.
详细描述
This is a pilot study which will enroll a maximum of 10 participants. There will be 3 different food entree preparations that participants will consume (1 entree per day within the 10 day period). The order in which participants eat the different entrees will be randomized. The 3 different food entree preparations are as follows: 1) prepared potato entree with no herbs and spices, 2) prepared potato entree paired with herbs and spices, 3) prepared potato entree with herbs and spices consumed at a subsequent meal.
Following enrollment, participants will be randomized to the order of entree preparation types and provided all of the entrees with the instructions for food preparation and order of consumption noted when they arrive at the scheduled study visit. The entrees will be standardized for caloric content, composition, and preparation method. Post-consumption glucose responses will be recorded by continuous glucose monitors, which will be provided to participants at the first study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index (BMI): 20-35
- •no dietary restriction or food allergies to study items
- •weight stable
- •access to a smart phone
- •willingness to wear a continuous glucose monitor for the duration of the study (at minimum 10 days)
排除标准
- •pregnancy or anticipating pregnancy or lactation
- •food allergy to study items
- •diagnosed diabetes (type 1 or 2) or taking diabetes medications
- •history of bariatric surgery
- •consumed >1 serving of potatoes daily before enrollment
- •5% weight loss or gain within the past 6 months
- •medical conditions or medication that would prevent the ability to comply with the treatment assignment and/or affect blood glucose or energy balance
- •condition which would prevent the ability to wear a continuous glucose monitor on the upper arm for the study duration
研究组 & 干预措施
Potato entree with no herbs or spices
consumption of a standardized potato entree, matched for macronutrient, calorie and preparation method across arms
干预措施: Potato entree (Other)
Potato entree with herbs or spices
consumption of a standardized potato entree including a mix of five herbs and spices at a fixed amount, matched for macronutrient, calorie and preparation method across arms
干预措施: Mix of five herbs and spices (Other)
Potato entree with herbs or spices
consumption of a standardized potato entree including a mix of five herbs and spices at a fixed amount, matched for macronutrient, calorie and preparation method across arms
干预措施: Potato entree (Other)
Potato entree with no herbs or spices, with herbs and spices mix at a subsequent meal
consumption of a standardized potato entree, matched for macronutrient, calorie and preparation method across arms - with a provision including a mix of five herbs and spices at a fixed amount to be consumed at a subsequent meal within the same day (>2 hours following the potato entree consumption)
干预措施: Mix of five herbs and spices (Other)
Potato entree with no herbs or spices, with herbs and spices mix at a subsequent meal
consumption of a standardized potato entree, matched for macronutrient, calorie and preparation method across arms - with a provision including a mix of five herbs and spices at a fixed amount to be consumed at a subsequent meal within the same day (>2 hours following the potato entree consumption)
干预措施: Potato entree (Other)
结局指标
主要结局
Post-prandial glucose response
时间窗: 0, 1, and 2 hours post-meal, as well as 24 hour continuous
Glucose response will be measured using continuous glucose monitors. These devices will capture changes in glucose response from the start of the meal to about 2 hours postprandial.
次要结局
- Acceptance assessment(0-10 days)
- Acceptance assessment(0-10 days)
研究者
Daniel L. Smith, Jr.
Associate Professor
University of Alabama at Birmingham