Ignite Creation Date:
2024-05-06 @ 8:14 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02692144
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2016-02-17
Brief Title:
Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals
Sponsor:
PepsiCo Global RD
Organization:
PepsiCo Global RD
Study Overview
Official Title:
Effect of an Optimized Savory Cluster on Glycemic and Insulinemic Responses in Healthy Individuals A Randomized Cross-over Study
Status:
COMPLETED
Status Verified Date:
2018-01
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:
This study was to test the hypothesis that an optimized savory cluster Test-cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber will elicit lower postprandial blood glucose and insulin responses than a Control-cluster made from general processing procedure and with typical ingredients commonly used in commercially available snacks or bars oats peanuts and corn syrup However since the Test-cluster contains 30 less available-carbohydrate 24g than the Control 33g the postprandial responses elicited by the Test-cluster was also compared with those after a portion of White-bread matched for available-carbohydrate content On 3 separate days 25 healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kgm² with fasting serum glucose 70mmolL 126 mgdL were asked to consume 1 serving 56g of the Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at intervals over the next 4 hr Each serving of Test-cluster and Control-cluster contained similar amounts of total carbohydrates protein fat and energy content Each serving of Test-cluster and White-bread had equivalent amount of 24g available carbohydrate
On each test occasion after subjects were weighed 2 fasting blood samples were obtained by finger-prick 5min apart and after the 2nd sample the subject started to consume a test meal Subjects were asked to consume the entire test meal within 10 min At the first bite a timer was started and blood samples for were taken for glucose analysis at 10 20 30 40 50 60 90 120 180 and 240 min after starting to eat Additional blood was taken into a separate vial at -5 0 20 40 60 90 120 180 and 240 min for insulin analysis Blood samples were obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample During the 4hr of the test participants remained seated quietly After the last blood sample participants were offered a snack and then allowed to leave
On each test occasion after subjects were weighed 2 fasting blood samples were obtained by finger-prick 5min apart and after the 2nd sample the subject started to consume a test meal Subjects were asked to consume the entire test meal within 10 min At the first bite a timer was started and blood samples for were taken for glucose analysis at 10 20 30 40 50 60 90 120 180 and 240 min after starting to eat Additional blood was taken into a separate vial at -5 0 20 40 60 90 120 180 and 240 min for insulin analysis Blood samples were obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample During the 4hr of the test participants remained seated quietly After the last blood sample participants were offered a snack and then allowed to leave
Detailed Description:
None
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