Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04599738
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2020-10-11
Brief Title:
Millet-based Muffins Glycaemic Response Insulinemic Response and Gastric Emptying
Sponsor:
Oxford Brookes University
Organization:
Oxford Brookes University
Study Overview
Official Title:
The Effect of Millet-based Muffins on Glycaemic Insulinemic Response and Gastric Emptying in Pre-diabetic Adults
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 milletThis 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 61 mmoll or 108 mgdl
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 61 to 69 mmoll for pre-diabetic participants and 61 mmoll 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 61mmoll 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 79 to 110 mmoll 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
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 61 to 69 mmoll for pre-diabetic participants and 61 mmoll 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 61mmoll 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 79 to 110 mmoll 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None