Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03994276
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2019-06-20
Brief Title:
The Postprandial Effects of Chick-Pea Consumption on Glucose Insulin and Gut Hormone Responses PEA-POD
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
The Postprandial Effects After Consumption of Chick-Pea Oral Doses on Glucose Insulin and Gut Hormone Responses The PEA-POD Study
Status:
COMPLETED
Status Verified Date:
2019-06
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:
Pulses have a high fibre content contribute to lowering fasting blood cholesterol levels and improving glycaemic control and have shown also considerable promise in supporting the dietary management of cardiovascular disease CVD type-2 diabetes mellitus T2DM and obesity It is now established that cellular integrity maintenance of cell wall structure is a key factor responsible for the low glycaemic index GI of pulses The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut Thus cell damage results in a loss of such properties and also the potential health benefits to consumers
This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients We have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility 60 resistant starch This chickpea powder CPP was found to be stable under long-term storage has a neutral taste and aroma and showed promise as a low GI flour-substitute
This study will investigate blood sugar insulin and gut hormone levels post-prandial glycaemic insulinaemic and hormone responses following the consumption of CPP consumed at breakfast as a drink and incorporated into a food matrix bread
This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients We have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility 60 resistant starch This chickpea powder CPP was found to be stable under long-term storage has a neutral taste and aroma and showed promise as a low GI flour-substitute
This study will investigate blood sugar insulin and gut hormone levels post-prandial glycaemic insulinaemic and hormone responses following the consumption of CPP consumed at breakfast as a drink and incorporated into a food matrix bread
Detailed Description:
The nutritional and potential long-term health benefits of consuming pulses have been well documented Pulses have a high fibre content contribute to lowering fasting blood cholesterol levels and improving glycaemic control and have shown also considerable promise in supporting the dietary management of cardiovascular disease CVD type-2 diabetes mellitus T2DM and obesity They are gluten-free and are also an affordable and accessible source of starch protein and dietary fibre It is now established that cellular integrity maintenance of cell wall structure is a key factor responsible for the low glycaemic index GI of pulses The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut Thus cell damage ie as occurs extensively during milling of pulses into flour results in a loss of such properties and also the potential health benefits to consumers
This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients that preserve the desirable low GI of whole pulses Incorporation of such ingredients has the potential to lower the glycaemic and insulinaemic responses to staple food products andor may promote satiety thereby ameliorating the dietary management of T2D and obesity and reducing the risk factors associated with these diseases Building on new understanding of the conditions required to preserve cellular integrity we have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility 60 resistant starch This chickpea powder CPP was found to be stable under long-term storage has a neutral taste and aroma and showed promise as a low GI flour-substitute
This study will investigate blood sugar insulin and gut hormone levels post-prandial glycaemic insulinaemic and hormone responses following the consumption of CPP consumed as a drink and incorporated into a food matrix bread It is hypothesised that the structure of the CCP will result in a reduced post-prandial glycaemic response while maintaining or improving the insulinaemic and gut hormone responses This regulation of blood sugar levels following a meal would be beneficial for people with impaired glucose metabolism such as T2DM This study will consist of two phases both utilising a three-arm random crossover design
Phase 1 aims to test the glucose response to unmodified CPP ie has not been cooked This will involve the consumption of the following test drinks containing 50g of available carbohydrate ie starch andor sugars 1 Glucose an oral glucose tolerance test OGTT 2 Control chickpea product no cellular integrity and 3 the CPP These test drinks will be consumed in random order on three separate visits In order to ensure the test carbohydrates remains in solution all test drinks will be made up in an equivalent volume of 330 ml bottled water containing chocolate flavouring Participants will be required to fast overnight a capillary blood glucose measurement will be taken at t0 followed by consumption of the test drink within 5 min Further capillary blood glucose measurements will be taken at t10 20 30 45 60 90 and 120 min Additionally participants will be provided with a Constant Glucose Monitor CGM that will be applied to the upper arm 24hrs prior to the first study day All three study visits will be completed in 12 days The length of CGM activity It is hypothesised that the cell wall integrity in the CPP drink will result in a reduced post-prandial glycaemic response compared to the control chickpea product and the OGTT standard
Outcome measures The primary outcome of Phase 1 will be the glycaemic response to the consumption of CPP drink compared to both the OGTT and control chickpea product In vitro studies suggest that maintenance of cellular integrity will reduce the early phase of post-prandial glycaemia as assessed by the incremental area under the curve iAUC iAUC0-60min and maximum blood glucose concentration Cmax Secondary measures such as the time to reach maximum blood glucose concentration Tmax iAUC0-120min and iAUC60-120min will also be assessed
Phase 2 aims to test the glucose insulin and gut hormone response to CPP incorporated into a staple food This will involve the consumption of wheat-based breads containing 50g of available carbohydrate and either 1 wheat bread control 2 wheat bread with 30 CPP substitution of wheat flour and 3 wheat bread with 60 CPP substitution of wheat flour These breads will be consumed as part of a breakfast following an overnight fast on three separate study visits Post-prandial concentrations of plasma glucose insulin glucose-dependent insulinotropic peptide GIP glucagon-like peptide 1 GLP-1 peptide YY PYY and C-peptide will be measured at commencement of meal t0 and following consumption at t15 30 45 60 90 120 180 and 240 min Additionally participants will be provided with a Constant Glucose Monitor CGM that will be applied to the upper arm 24hrs prior to each study day
Outcome measures The primary outcome of Phase 2 will be iAUC0-60min for plasma glucose concentrations and corresponding plasma insulinC-peptide responses demonstrating the ability of cell wall integrity to limit starch digestion and therefore the rate of glucose appearance in the blood in the early phase of post-prandial glycaemia Secondary outcome variables include iAUC0-120min iAUC0-240min 30-90 and 90-240 Cmax Tmax changes from baseline up to 240 min for plasma glucose insulin and C-peptide concentrations For the gut hormones plasma GIP PYY and GLP-1 concentrations will be assessed using the same outcome variables Subjective measures of study meals and ad libitum meal palatability will be collected at t10 min and post lunch respectively Subjective measures of mood satiety and digestive comfort will be collected t0 10 30 60 120 180 210 240 min and post lunch The energy intake from the ad libitum lunch provided following the experimental period will also be compared Subjective measures will be summarised using descriptive statistics
This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients that preserve the desirable low GI of whole pulses Incorporation of such ingredients has the potential to lower the glycaemic and insulinaemic responses to staple food products andor may promote satiety thereby ameliorating the dietary management of T2D and obesity and reducing the risk factors associated with these diseases Building on new understanding of the conditions required to preserve cellular integrity we have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility 60 resistant starch This chickpea powder CPP was found to be stable under long-term storage has a neutral taste and aroma and showed promise as a low GI flour-substitute
This study will investigate blood sugar insulin and gut hormone levels post-prandial glycaemic insulinaemic and hormone responses following the consumption of CPP consumed as a drink and incorporated into a food matrix bread It is hypothesised that the structure of the CCP will result in a reduced post-prandial glycaemic response while maintaining or improving the insulinaemic and gut hormone responses This regulation of blood sugar levels following a meal would be beneficial for people with impaired glucose metabolism such as T2DM This study will consist of two phases both utilising a three-arm random crossover design
Phase 1 aims to test the glucose response to unmodified CPP ie has not been cooked This will involve the consumption of the following test drinks containing 50g of available carbohydrate ie starch andor sugars 1 Glucose an oral glucose tolerance test OGTT 2 Control chickpea product no cellular integrity and 3 the CPP These test drinks will be consumed in random order on three separate visits In order to ensure the test carbohydrates remains in solution all test drinks will be made up in an equivalent volume of 330 ml bottled water containing chocolate flavouring Participants will be required to fast overnight a capillary blood glucose measurement will be taken at t0 followed by consumption of the test drink within 5 min Further capillary blood glucose measurements will be taken at t10 20 30 45 60 90 and 120 min Additionally participants will be provided with a Constant Glucose Monitor CGM that will be applied to the upper arm 24hrs prior to the first study day All three study visits will be completed in 12 days The length of CGM activity It is hypothesised that the cell wall integrity in the CPP drink will result in a reduced post-prandial glycaemic response compared to the control chickpea product and the OGTT standard
Outcome measures The primary outcome of Phase 1 will be the glycaemic response to the consumption of CPP drink compared to both the OGTT and control chickpea product In vitro studies suggest that maintenance of cellular integrity will reduce the early phase of post-prandial glycaemia as assessed by the incremental area under the curve iAUC iAUC0-60min and maximum blood glucose concentration Cmax Secondary measures such as the time to reach maximum blood glucose concentration Tmax iAUC0-120min and iAUC60-120min will also be assessed
Phase 2 aims to test the glucose insulin and gut hormone response to CPP incorporated into a staple food This will involve the consumption of wheat-based breads containing 50g of available carbohydrate and either 1 wheat bread control 2 wheat bread with 30 CPP substitution of wheat flour and 3 wheat bread with 60 CPP substitution of wheat flour These breads will be consumed as part of a breakfast following an overnight fast on three separate study visits Post-prandial concentrations of plasma glucose insulin glucose-dependent insulinotropic peptide GIP glucagon-like peptide 1 GLP-1 peptide YY PYY and C-peptide will be measured at commencement of meal t0 and following consumption at t15 30 45 60 90 120 180 and 240 min Additionally participants will be provided with a Constant Glucose Monitor CGM that will be applied to the upper arm 24hrs prior to each study day
Outcome measures The primary outcome of Phase 2 will be iAUC0-60min for plasma glucose concentrations and corresponding plasma insulinC-peptide responses demonstrating the ability of cell wall integrity to limit starch digestion and therefore the rate of glucose appearance in the blood in the early phase of post-prandial glycaemia Secondary outcome variables include iAUC0-120min iAUC0-240min 30-90 and 90-240 Cmax Tmax changes from baseline up to 240 min for plasma glucose insulin and C-peptide concentrations For the gut hormones plasma GIP PYY and GLP-1 concentrations will be assessed using the same outcome variables Subjective measures of study meals and ad libitum meal palatability will be collected at t10 min and post lunch respectively Subjective measures of mood satiety and digestive comfort will be collected t0 10 30 60 120 180 210 240 min and post lunch The energy intake from the ad libitum lunch provided following the experimental period will also be compared Subjective measures will be summarised using descriptive statistics
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