Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630312
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Glycemic Response of Whole Beans and Bean Products
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Glycemic Response of Whole Beans and Bean Products
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BH-GLY
Brief Summary:
The main goal of this clinical trial is to learn if alpha-galactosidase tradename Beano changes in post-prandial after-meal blood glucose after eating whole cooked whole pulses or pulse-based pasta products in comparison to the same foods without alpha-galactosidase Comparison of postprandial blood insulin and triglyceride levels appetite and gastrointestinal symptoms of flatulence bloating and stool changes will be evaluated by comparisons of the alpha-galactosidase and the pulse form whole vs pasta In addition to blood glucose such as flatulence and bloating postprandial glucose insulin and appetite of individuals
The study design is a 4x4 crossover and the population is healthy volunteers aged 21-34 with normal glucose response and body weight
The primary hypothesis is that alpha-galactosidase will cause increased postprandial blood glucose for both whole and pasta pulse foods The secondary hypothesis is that gastrointestinal symptoms will be less for both meals with the alpha-galactosidase Other comparisons are exploratory
Participants will come in fasting for one morning per week and receive the food treatments in randomized order Test measurements will be taken over a four hour period
The study design is a 4x4 crossover and the population is healthy volunteers aged 21-34 with normal glucose response and body weight
The primary hypothesis is that alpha-galactosidase will cause increased postprandial blood glucose for both whole and pasta pulse foods The secondary hypothesis is that gastrointestinal symptoms will be less for both meals with the alpha-galactosidase Other comparisons are exploratory
Participants will come in fasting for one morning per week and receive the food treatments in randomized order Test measurements will be taken over a four hour period
Detailed Description:
The 4 test treatments yellow whole bean yellow whole bean and alpha-galactosidase AGS yellow bean flour pasta yellow bean flour pasta and AGS will be administered in semi-randomized order once every four weeks Participants will be randomized to whole beans or bean pasta and within the meal group randomized again to receive the AGS treatment or not Pulses will be served with a standardized amount of spaghetti sauce The treatment intervention consisted of 16 gm of pasta sauce with either no AGS or 600 GALU of AGS
The test participants were required to consume the entire test meal in 7-9 minutes while being observed Venous blood samples were collected for blood glucose and insulin levels at time 0 fasting and at 30 60 90 120 and 180 minutes post treatment timing of the post-treatment draws started at time 0 post-treatment which is when the participant finishes consuming the treatment meal Triglycerides were measured at time 0 60 120 180 minutes post-treatment
Blood samples were processed according to laboratory instructions and sent out for analysis by Quest Diagnostics Breath hydrogen samples were collected at times 0 fasting 15 30 45 60 75 90 105 120 135 150 165 and 180 minutes post treatment Samples were measured at the end of the 4-hour test period in sequential order on the same calibrated instrument
Anthropometric measures of weight height waist circumference and blood pressure were collected at screening and weight waist circumference and blood pressure will be collected at the start of each test day Thirteen hours before testing participants will consume a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes This control meal was selected by each participant before the start of the study Each participant was provided the same frozen meal every time since the subjects serve as their own controls The day before test day participants completed a 24-hour food recall satiety and gastrointestinal questionnaires
During each test day participants completed satiety questionnaires sensory questionnaires and a gastrointestinal questionnaire Satiety questionnaires were completed every 45 minutes after the first bite The sensory questionnaire was completed immediately following the entire test meal being eaten The gastrointestinal questionnaire was completed the evening before the test day at 165 minutes following the first bite of the test meal the evening of testing and the following evening
The test participants were required to consume the entire test meal in 7-9 minutes while being observed Venous blood samples were collected for blood glucose and insulin levels at time 0 fasting and at 30 60 90 120 and 180 minutes post treatment timing of the post-treatment draws started at time 0 post-treatment which is when the participant finishes consuming the treatment meal Triglycerides were measured at time 0 60 120 180 minutes post-treatment
Blood samples were processed according to laboratory instructions and sent out for analysis by Quest Diagnostics Breath hydrogen samples were collected at times 0 fasting 15 30 45 60 75 90 105 120 135 150 165 and 180 minutes post treatment Samples were measured at the end of the 4-hour test period in sequential order on the same calibrated instrument
Anthropometric measures of weight height waist circumference and blood pressure were collected at screening and weight waist circumference and blood pressure will be collected at the start of each test day Thirteen hours before testing participants will consume a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes This control meal was selected by each participant before the start of the study Each participant was provided the same frozen meal every time since the subjects serve as their own controls The day before test day participants completed a 24-hour food recall satiety and gastrointestinal questionnaires
During each test day participants completed satiety questionnaires sensory questionnaires and a gastrointestinal questionnaire Satiety questionnaires were completed every 45 minutes after the first bite The sensory questionnaire was completed immediately following the entire test meal being eaten The gastrointestinal questionnaire was completed the evening before the test day at 165 minutes following the first bite of the test meal the evening of testing and the following evening
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None