Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05556837
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-09-22
Brief Title:
Effect of Extruded Cereals Enriched With β-glucan on Postprandial Plasma Glucose and Serum Insulin Responses
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
Study Overview
Official Title:
Effect of Extruded Cereals Enriched With β-glucan From Oats or Barley on Postprandial Plasma Glucose and Serum Insulin Responses in Generally Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
β-glucan BG is a viscous dietary fiber present in barley and oats that when added to carbohydrate containing foods reduces the postprandial glycemic response PPGR which is considered to be beneficial to health In 2011 the European Food Safety Authority EFSA concluded that 4g of either oat BG OBG or barley BG BBG per 30g available carbohydrate avCHO is required to obtain a reduction in PPGR however this is an impractically large amount of BG to incorporate into palatable foods A recent systematic review and meta-analysis found that doses of OBG well below 4g30g avCHO can significantly reduce PPGR
It is therefore hypothesized that 25g avCHO portions of cereal containing 14-15g of either OBG or BBG will elicit a statistically significantly lower PPGR compared to a control cereal containing no BG
It is therefore hypothesized that 25g avCHO portions of cereal containing 14-15g of either OBG or BBG will elicit a statistically significantly lower PPGR compared to a control cereal containing no BG
Detailed Description:
Statistical Analysis
Analysis populations The intention-to-treat ITT population includes all subjects who consumed at least 1 of the 3 test meals in that phase The per-protocol PP population for each phase includes all subjects who completed all 3 tests in that phase with no serious protocol violations There may also be a group termed PPDO dropouts defined as the PP population plus subjects who competed 1 or 2 of the 3 tests with no serious protocol violations
Conclusions will be based on the glucose and insulin endpoints for the PP population To assess the potential impact of excluding those subjects who dropped out after completing 1 or 2 tests a secondary analysis will be performed for the PPDO population where the missing values are imputed using methods described by Snedecor and Cochran
Distribution of data the methods of analyzing continuous data assume that the data are normally distributed Normality of distribution will be tested by comparing the actual distribution of the Z scores to the expected distribution using the chi-square test with the data taken to be normally distributed if p005 Non-normally distributed data will be transformed by in order of preference log-transformation square-root-transformation some other method until the transformed data are normally distributed
Primary endpoint the primary endpoint will be assessed as follows serum glucose concentrations will be subjected to repeated-measures analysis of variance ANOVA using the linear model analyzing for the main effects of time and treatment and the timetreatment interaction After demonstrating a significant timetreatment interaction indicating that the pattern of glucose response differs significantly among treatments the values for iAUC 0-2h will be analyzed by ANOVA for the main effect of treatment after demonstrating significant heterogeneity the mean for each of the 2 test cereals will be compared only to that of each respective control cereal using Dunnetts Test to adjust for multiple comparisons The 2 test cereals will not be compared to each other The criterion for significance will be two-tailed p005
Secondary endpoints the results for insulin iAUC will be assessed as described for the primary endpoint Serum glucose and insulin concentrations and increments at each time point will be subjected to repeated-measures ANOVA Upon demonstration of significant heterogeneity individual means of the test and matched control cereals will be compared using Dunnetts Test to adjust for multiple comparisons The 2 test cereals will not be compared to each other The criterion for significance will be two-tailed p005
Statistical Power
The average within-individual CV of glucose iAUC elicited by repeated tests of oral glucose is within the range of 22-25 in our previous studies in healthy individuals To demonstrate that both test cereals differ significantly from the control each comparison must have 90 power to detect a significant difference in order to obtain 80 power to detect both significant differences since 0902 081 Assuming a SD of 25 and using the normal distribution n40 subjects provide 95 power to detect a significant difference of 20 between test and control cereals
Analysis populations The intention-to-treat ITT population includes all subjects who consumed at least 1 of the 3 test meals in that phase The per-protocol PP population for each phase includes all subjects who completed all 3 tests in that phase with no serious protocol violations There may also be a group termed PPDO dropouts defined as the PP population plus subjects who competed 1 or 2 of the 3 tests with no serious protocol violations
Conclusions will be based on the glucose and insulin endpoints for the PP population To assess the potential impact of excluding those subjects who dropped out after completing 1 or 2 tests a secondary analysis will be performed for the PPDO population where the missing values are imputed using methods described by Snedecor and Cochran
Distribution of data the methods of analyzing continuous data assume that the data are normally distributed Normality of distribution will be tested by comparing the actual distribution of the Z scores to the expected distribution using the chi-square test with the data taken to be normally distributed if p005 Non-normally distributed data will be transformed by in order of preference log-transformation square-root-transformation some other method until the transformed data are normally distributed
Primary endpoint the primary endpoint will be assessed as follows serum glucose concentrations will be subjected to repeated-measures analysis of variance ANOVA using the linear model analyzing for the main effects of time and treatment and the timetreatment interaction After demonstrating a significant timetreatment interaction indicating that the pattern of glucose response differs significantly among treatments the values for iAUC 0-2h will be analyzed by ANOVA for the main effect of treatment after demonstrating significant heterogeneity the mean for each of the 2 test cereals will be compared only to that of each respective control cereal using Dunnetts Test to adjust for multiple comparisons The 2 test cereals will not be compared to each other The criterion for significance will be two-tailed p005
Secondary endpoints the results for insulin iAUC will be assessed as described for the primary endpoint Serum glucose and insulin concentrations and increments at each time point will be subjected to repeated-measures ANOVA Upon demonstration of significant heterogeneity individual means of the test and matched control cereals will be compared using Dunnetts Test to adjust for multiple comparisons The 2 test cereals will not be compared to each other The criterion for significance will be two-tailed p005
Statistical Power
The average within-individual CV of glucose iAUC elicited by repeated tests of oral glucose is within the range of 22-25 in our previous studies in healthy individuals To demonstrate that both test cereals differ significantly from the control each comparison must have 90 power to detect a significant difference in order to obtain 80 power to detect both significant differences since 0902 081 Assuming a SD of 25 and using the normal distribution n40 subjects provide 95 power to detect a significant difference of 20 between test and control cereals
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