Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03068039
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2017-02-24
Brief Title:
Millets and Oats MRI
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Gastrointestinal Responses to Millet and Oats Breakfast Interventions Assessed by MRI
Status:
COMPLETED
Status Verified Date:
2017-10
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:
MOM
Brief Summary:
Breakfast porridges made from milled grains are commonly eaten worldwide Traditionally different grains are used in different countries For example oats are more common in the Anglo-Saxon countries whilst millet is very common in parts of India and Africa However the nutritional value of different grains and their potential effects on the body may vary dramatically for example the effect on blood sugar on how fast the stomach empties after eating and how full people may feel
RESEARCH QUESTION The investigators think that a pearl millet breakfast will cause a smaller rise in blood sugar compared with an oat breakfast containing the same number of calories The investigators also think that there will be a difference in how full people feel and how fast their stomach will empty These 2 breakfasts will be fed to each one of 26 healthy volunteers one week apart A safe medical imaging method MRI will be used to look at how quickly the breakfast empty from the stomach and how this affects the small bowel Blood glucose levels will be measured using a finger prick test the same as used by diabetics and some small blood samples will be taken from a vein in the arm to measure the chemicals released by the gut after feeding gut hormones
RESEARCH QUESTION The investigators think that a pearl millet breakfast will cause a smaller rise in blood sugar compared with an oat breakfast containing the same number of calories The investigators also think that there will be a difference in how full people feel and how fast their stomach will empty These 2 breakfasts will be fed to each one of 26 healthy volunteers one week apart A safe medical imaging method MRI will be used to look at how quickly the breakfast empty from the stomach and how this affects the small bowel Blood glucose levels will be measured using a finger prick test the same as used by diabetics and some small blood samples will be taken from a vein in the arm to measure the chemicals released by the gut after feeding gut hormones
Detailed Description:
Background Porridge breakfasts from various grains are a staple source of energy for many populations worldwide The grains used in the porridges differ between regions mostly due to the crops historically grown For example oats are more common in the Anglo-Saxon countries whilst millet is very common in parts of India and Africa Consumption of whole grains has been associated with a variety of health benefits ranging from lower blood glucose levels improved insulin responses reduced cholesterol and increased diversity of the microbiota Of particular interest to this study are recent suggestions that different grains and particularly millet grains may have enhanced health benefits on glucose and insulin metabolism This may be due to different rates of digestion and absorption for example because of grain specific differences in starch digestibility This could affect gastric emptying and in turn post prandial glycaemia and impact on satiety However little is known about possible differences in gastric emptying between breakfast porridges from different grains and possible relationship with glucose insulin and appetite
The research group in Nottingham has world-leading expertise in imaging foods in the body and gastrointestinal function using non-invasive Magnetic Resonance Imaging MRI techniques which are particularly well suited for this kind of investigations study
Aims
1 to collect data on postprandial glucose levels and hormone peptide response of isoenergetic breakfast porridges made from oats and pearl millet
2 to collect data on their gastric emptying and satiety
3 to compare postprandial glucose levels gastric emptying and satiety for the treatments 4 to explore relationships between glucose levels gastric emptying and satiety
Experimental protocol and methods 26 healthy volunteers will participate in this 2-way study They will attend one morning for each study with the studies separated by approximately a week Before the test meal and after that approximately every 15 min for 2 hours the level of sugar glucose in their blood will be measured using the finger prick method as diabetics commonly do to monitor their blood sugars Venous blood samples will also be collected from a cannula placed in the forearm to measure gut hormones such as Peptide YY GIP GLP-1 and insulin The subjects will be scanned on a research dedicated 15T MRI scanner The subjects will be scanned at baseline immediately after the test meal and then every 30 minutes for 2 hours postprandially At baseline and every time the subjects come out of the MRI scanner they will be asaked to rate their feelings of fullness hunger and appetite on 100mm VAS scales Each subject will be fed two isoenergetic breakfast meals -one on each visit Oat and Pearl millet breakfast porridge sourced from supermarkets or food manufacturers These will be cooked in water to avoid confounding factor with milk The test breakfast will have 220 kcal slightly higher than a commonly recommended average portion of 185 kcal After this the subjects will be asked to eat as much of a pasta meal as they wish and note how much they have eaten as an objective measure of food consumption The subjects will also complete a food diary for the rest of the day
Measurable endpoints statistical power Primary endpoint Incremental Area Under the Curve of post prandial blood glucose up to 2h AUC2h Secondary endpoints Area Under the Curve of post prandial gastric volumes up to 2h AUC2h postprandial hormone peptide response insulin and post prandial VAS scores up to 2h
Descriptive and exploratory measurements Time to Peak of blood glucose Area Under the Curve for appetite Fullness Hunger Prospective food consumption up to 2h The amount of pasta meal eaten ad libitum Energy intake for the day from food diaries
Correlations between blood MRI and satiety data Using Satiety data Hunger from our pilot study we can calculate sample size needed using a crossover paired design with alpha005 and a power of 80 using n26 participants
The data will be assessed for normality using the Shapiro-Wilk test and other such methods as appropriate Where normally distributed endpoints will be assessed using parametric methods
T test primary endpoint and AUC2h secondary endpoints T test of Time to Peak Correlation Pearsons or Spearman between blood glucose MRI and satiety data
The research group in Nottingham has world-leading expertise in imaging foods in the body and gastrointestinal function using non-invasive Magnetic Resonance Imaging MRI techniques which are particularly well suited for this kind of investigations study
Aims
1 to collect data on postprandial glucose levels and hormone peptide response of isoenergetic breakfast porridges made from oats and pearl millet
2 to collect data on their gastric emptying and satiety
3 to compare postprandial glucose levels gastric emptying and satiety for the treatments 4 to explore relationships between glucose levels gastric emptying and satiety
Experimental protocol and methods 26 healthy volunteers will participate in this 2-way study They will attend one morning for each study with the studies separated by approximately a week Before the test meal and after that approximately every 15 min for 2 hours the level of sugar glucose in their blood will be measured using the finger prick method as diabetics commonly do to monitor their blood sugars Venous blood samples will also be collected from a cannula placed in the forearm to measure gut hormones such as Peptide YY GIP GLP-1 and insulin The subjects will be scanned on a research dedicated 15T MRI scanner The subjects will be scanned at baseline immediately after the test meal and then every 30 minutes for 2 hours postprandially At baseline and every time the subjects come out of the MRI scanner they will be asaked to rate their feelings of fullness hunger and appetite on 100mm VAS scales Each subject will be fed two isoenergetic breakfast meals -one on each visit Oat and Pearl millet breakfast porridge sourced from supermarkets or food manufacturers These will be cooked in water to avoid confounding factor with milk The test breakfast will have 220 kcal slightly higher than a commonly recommended average portion of 185 kcal After this the subjects will be asked to eat as much of a pasta meal as they wish and note how much they have eaten as an objective measure of food consumption The subjects will also complete a food diary for the rest of the day
Measurable endpoints statistical power Primary endpoint Incremental Area Under the Curve of post prandial blood glucose up to 2h AUC2h Secondary endpoints Area Under the Curve of post prandial gastric volumes up to 2h AUC2h postprandial hormone peptide response insulin and post prandial VAS scores up to 2h
Descriptive and exploratory measurements Time to Peak of blood glucose Area Under the Curve for appetite Fullness Hunger Prospective food consumption up to 2h The amount of pasta meal eaten ad libitum Energy intake for the day from food diaries
Correlations between blood MRI and satiety data Using Satiety data Hunger from our pilot study we can calculate sample size needed using a crossover paired design with alpha005 and a power of 80 using n26 participants
The data will be assessed for normality using the Shapiro-Wilk test and other such methods as appropriate Where normally distributed endpoints will be assessed using parametric methods
T test primary endpoint and AUC2h secondary endpoints T test of Time to Peak Correlation Pearsons or Spearman between blood glucose MRI and satiety data
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