跳至主要内容
临床试验/NCT04599738
NCT04599738已完成不适用

The Effect of Millet-based Muffins on Glycaemic, Insulinemic Response and Gastric Emptying in Pre-diabetic Adults

Oxford Brookes University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年3月6日最近更新:
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
Change in glycaemic response from baseline for 180 minutes

研究概览

简要总结

Millet is a functional grain that has attracted the attention of scientists for many years due to its significant benefits to human health. Research has shown that millets have a high antioxidant capacity and polyphenol content which can contribute to a reduced risk of some chronic diseases such as type 2 diabetes and its complications. This study aimed to assess the glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) after the consumption of millet-based muffins in pre-diabetic and healthy participants.

This was a single-blind, randomized controlled crossover study in which participants consumed one control muffin (wheat) and one test muffin (millet). During each session, participants were required to consume either the test or the control muffin, consuming the alternative on the next visit. Then, 10 finger-prick blood samples were taken for the determination of glucose and insulin over 4 hours. 13Carbon (13C) sodium acetate was added to the muffins (control and test) in order to measure gastric emptying from the breath samples collected.

详细描述

This study aimed to assess the glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) after the consumption of millet-based muffins in pre-diabetic and healthy participants. This was a single-blind, randomized controlled crossover study in which participants consumed one control muffin (wheat) and one test muffin (millet).This study investigated the effect of polyphenol-rich millet-based muffin on glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) in healthy and pre-diabetic participants (people with prediabetes have blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes - the normal fasting blood glucose level is below 6.1 mmol/l or 108 mg/dl).

After potential participants have read the Participant Information Sheet (PIS) and signed the consent form, they were screened during the first visit to measure fasting blood glucose (FBG; fasting blood glucose should be between 6.1 to 6.9 mmol/l for pre-diabetic participants and < 6.1 mmol/l for healthy participants ).If eligible for the study, body weight and height and blood pressure were taken in the Functional Food Centre (currently known as Oxford Brookes Centre for Nutrition and Health). If the fasting blood glucose test was less than 6.1mmol/l (participants were informed of their fasting blood glucose result and given the choice either to do Oral glucose tolerance test (OGTT) to check for Impaired Glucose Tolerance (IGT), participate in the healthy group or to be excluded). If the participant agreed to continue and had one or more of the pre-diabetes inclusion criteria, they could complete an oral glucose tolerance test (OGTT) over 2 hours.( An oral glucose tolerance test involves taking a fasting sample of blood and then taking a very sweet drink containing 75g of glucose. After having this drink participants had to stay at rest until a further blood sample is taken after 2 hours.) If their 2 h blood glucose result was between 7.9 to 11.0 mmol/l, they were considered eligible to participate in the study as a prediabetic participant, and were asked to come for a subsequent visit in order to begin the study. If the participant does not have IGT, they had the option to take part in the study as a healthy participant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for healthy participants
  • Aged 18-65 years
  • Body mass index (BMI) ≤ 30kg/m2
  • Fasting blood glucose < 6.1 mmol/l
  • Non-pregnant and non-lactating
  • No known diabetes or impaired glucose tolerance
  • No medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients
  • No major medical or surgical event requiring hospitalisation within the preceding three months
  • No use of steroids, protease inhibitors or antipsychotics
  • No food allergy to millet, wheat, egg and milk.
  • At least one of the following for pre-diabetes participants Fasting blood glucose 6.1-6.9 mmol/l (108-125 mg/ dI) - (WHO, 2006) or/and an Oral glucose tolerance test (OGTT) at 2 hours 7.9 to 11.0 mmol/l

排除标准

  • • Pregnant and lactating
  • Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients
  • Medical or surgical event requiring hospitalisation within the preceding three months
  • Use of steroids, protease inhibitors or antipsychotics (because of their effects on glucose regulation of appetite or influence digestion and absorption of nutrients).
  • Food allergy to study products (millet. wheat, egg, milk, butter, sugar).

结局指标

主要结局

Change in glycaemic response from baseline for 180 minutes

时间窗: 180 minutes

Capillary blood glucose was measured for 180 minutes at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes

Change in insulin response from baseline for 180 minutes

时间窗: 180 minutes

Capillary plasma insulin was measured for 180 minutes at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes

次要结局

  • Satiety by visual analogue scale for 4 hours(4hours)
  • Gastric emptying for 4 hours(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sangeetha Thondre

Senior Lecturer

Oxford Brookes University

研究点 (2)

Loading locations...

相似试验