跳至主要内容
临床试验/NCT05957224
NCT05957224尚未招募不适用

An Intervention Comparing Changes in the Plasma Glucose Profile Over a Three-hour Timespan in Persons With T2DM Following Caribbean Shake vs Glucerna Intake: A Double Blinded, Cross-over Design

The University of The West Indies0 个研究点目标入组 25 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
主要终点
Change in plasma glucose concentration post oral intake of shake

研究概览

简要总结

Following a meal, in nondiabetic individuals, blood glucose rises to peak at 1hr and returns to baseline in 2 - 3 hours. In T2DM, this peak is higher and prolonged. Meal plans for persons with T2DM should comprise evenly spaced, complex carbohydrate portions in order to avoid post-prandial glucose spikes. Researchers have developed an expanded line of Caribbean-flavoured, low-calorie meal-replacement shakes which have been formulated to match the macronutrient and caloric content of a commercially available brand. In this trial investigators aim to (1) examine the change in glucose levels post intake of Caribbean vs the commercially available brand and (2) to conduct a comparative sensory analysis of the two shakes.

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
Double (Participant, Outcomes Assessor)

盲法说明

The participants will be blinded to the intervention as the shakes will be given in unmarked containers - however as the flavours are very different it is likely that participants will be able to tell them apart. Data analysts will be blinded.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of T2DM for any length of time,
  • last HbA1C (within the last 6 months) of < / = 8%

排除标准

  • On insulin for any length of time

结局指标

主要结局

Change in plasma glucose concentration post oral intake of shake

时间窗: 30 minutes, 60 minutes and 120 minutes post oral intake of shake

次要结局

  • Sensory analysis of taste, texture, smell and appearance of shakes(within 1hour post oral intake of shake)

研究者

申办方类型
Other
责任方
Sponsor

相似试验