NCT02455934已完成不适用
The Dose-response Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level in Healthy Volunteers and Volunteers With Impaired Fasting Glucose
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
研究概览
简要总结
Randomized, double-blind, crossover-trial, 30 subjects in each groups, either males or females, normal fasting glucose or pre-diabetes, aged > 18 years old to perform oral sucrose tolerance with either one of the 5 study products
- Sucrose 50 g
- Sucrose 50 g + D-allulose (psicose) 2.5 g
- Sucrose 50 g + D-allulose (psicose) 5 g
- Sucrose 50 g + D-allulose (psicose) 7.5 g
- Sucrose 50 g + D-allulose (psicose) 10 g
Primary endpoints:
- To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on glucose tolerance
- To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on insulin levels
详细描述
Objectives Primary objectives
- To investigate the dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
- To investigate the dose-response effects of D-allulose (psicose) with sucrose beverage on insulin levels
Subjects and methods Study product A. Sucrose 50 g B. Sucrose 50 g + D-allulose (psicose) 2.5 g C. Sucrose 50 g + D-allulose (psicose) 5 g D. Sucrose 50 g + D-allulose (psicose) 7.5 g E. Sucrose 50 g + D-allulose (psicose) 10 g
Study plan Screening (visit 0)
- Obtain inform consent
- History taking for medical problems, smoking, alcoholic drinking, concurrent medication, contraception or menopausal status, weight history
- Measure body weight, height and calculated BMI
- Measure waist and hip circumference
- Body composition measurement by bioelectrical impedance analysis (BIA)
- Complete physical examination
- Urine pregnancy test in all female of childbearing potential
- Provide 24-hour food record
- Ask to come back within 1 week
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age > 18 years and legal age of consent.
- •If female, the participant is either post-menopausal or surgically sterilized, or has a negative urine kit pregnancy test within 7 days prior to enrollment and will use adequate contraception during the study.
- •The participant has provided written informed consent prior to admission to the study.
- •Participant is able to join the entire study with 8 weeks.
- •Participant is able to keep 24-hour dietary record a day prior to each visit.
排除标准
- •Pregnancy or lactation
- •Diagnosed with diabetes mellitus
- •Those who take any medication that might be able to increase plasma glucose 1 month prior to the study or during in the study
- •Acute illness within 1 weeks prior to the study
- •Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation
- •Immunocompromised status, including a debilitated state or malignancy
- •Active liver, renal, thyroid diseases
- •Lack of ability or willingness to give informed consent
- •Enrolled in any other clinical study within 3 months before enrolment
- •Any people whose life style is irregular, for example, person works at night shifts.
结局指标
主要结局
The dose-response effects of D-allulose (psicose) with sucrose beverage on glucose tolerance
时间窗: 2 hours
oral sucrose tolerance test with sucrose +/- allulose
次要结局
- Time to peak plasma glucose concentration(2 hours)
研究者
Supawan Buranapin
Assisstant Professor Supawan Buranapin, MD
Chiang Mai University
研究点 (2)
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