Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04515277
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2020-08-07
Brief Title:
Study to Evaluate the Effect of Gum Acacia FibregumTM on Post-prandial Glucose Insulin Levels and Food Intake
Sponsor:
Nexira
Organization:
Nexira
Study Overview
Official Title:
Double-blind Randomized Controlled Three-way Cross-over Study to Evaluate the Effect of Gum Acacia FibregumTM on Post-prandial Glucose and Insulin Levels and Food Intake
Status:
COMPLETED
Status Verified Date:
2020-08
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:
Study to evaluate the effect of gum acacia FibregumTM on post-prandial glucose and insulin levels and food intake in normal-weight and overweight subjects during a 2-7 weeks intervention period In addition tolerability and safety of gum acacia FibregumTM will be assessed
Detailed Description:
Gum arabic is a heteropolysaccharide molecular weight 350-850 kDa harvested from Acacia seyal or Acacia senegal It is highly soluble and broadly used in numerous solid and liquid food matrices
For the assessment of non-digestible carbohydrates as dietary fiber it is eminent to demonstrate that its consumption is related to a specific beneficial physiological effect shown in an appropriate clinical study The aim of the present trial was to expand the clinical evidence with respect to beneficial effects of gum acacia on post-prandial blood glucose levels post-prandial insulin levels and prospective ad libitum food intake in normal-weight and overweight subjects
The present double-blind randomized controlled three-way cross-over study was to evaluate the effect of gum acacia versus no treatment on post-prandial glucose PPG levels in normal-weight and overweight subjects during a 2-7 weeks intervention period
Additionally post-prandial insulin PPI levels prospective ad libitum food intake as well as the safety and tolerability of gum acacia were assessed
For the assessment of non-digestible carbohydrates as dietary fiber it is eminent to demonstrate that its consumption is related to a specific beneficial physiological effect shown in an appropriate clinical study The aim of the present trial was to expand the clinical evidence with respect to beneficial effects of gum acacia on post-prandial blood glucose levels post-prandial insulin levels and prospective ad libitum food intake in normal-weight and overweight subjects
The present double-blind randomized controlled three-way cross-over study was to evaluate the effect of gum acacia versus no treatment on post-prandial glucose PPG levels in normal-weight and overweight subjects during a 2-7 weeks intervention period
Additionally post-prandial insulin PPI levels prospective ad libitum food intake as well as the safety and tolerability of gum acacia were assessed
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