Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02367989
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2015-02-04
Brief Title:
Effects of Barley on Glucose Control
Sponsor:
St Boniface Hospital
Organization:
St Boniface Hospital
Study Overview
Official Title:
A Dose-response Double-blind Randomized Controlled Cross-over Trial Examining the Effect of Barley Beta-glucan on Post-prandial Glucose Response in Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes CDA 2013 In this context the presence of soluble dietary fibre in carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose response PPGR Among these oat and barley derived β-glucan have received tremendous attention for their biological effects including their ability to reduce PPGR in a wide variety of food matrices Poppitt et al 2007 A health claim for PPGR would increase market demand for food grade barley and help those who want to limit the rise in blood sugar after a meal choose products to meet their goals but there are several gaps in the literature that need to be filled before a submission to Health Canada can be successful 1 test foods in appropriate serving sizes 2 test both the glucose and insulin response 3 include a reference product that matches in total fibre macronutrient and energy profile 4 perform dose response The proposed study design will address all of these gaps in the current literature and take into consideration Health Canadas guidance document for health claims related to the reduction in PPGR which sets out the criteria by which the validity of such claims will be assessed
Hypothesis
Barley β-glucan will reduce the PPGR in healthy participants in a dose dependent manner
Specific objectives
1 To determine the minimum and most effective dose of barley β-glucan in waffles on PPGR and insulin response in a cross-over randomized controlled clinical trial
2 To assess the effect of barley β-glucan in waffles on appetite-related sensations using visual analog scales
3 To demonstrate whether the test and reference products were liked or disliked similarly by participants
4 To assess any gastrointestinal side effects from eating the test products
Hypothesis
Barley β-glucan will reduce the PPGR in healthy participants in a dose dependent manner
Specific objectives
1 To determine the minimum and most effective dose of barley β-glucan in waffles on PPGR and insulin response in a cross-over randomized controlled clinical trial
2 To assess the effect of barley β-glucan in waffles on appetite-related sensations using visual analog scales
3 To demonstrate whether the test and reference products were liked or disliked similarly by participants
4 To assess any gastrointestinal side effects from eating the test products
Detailed Description:
A double-blind randomized controlled cross-over study designed to examine the PPGR to barley β-glucan will be conducted at the IH Asper Clinical Research Institute in Winnipeg Manitoba A total of 24 healthy volunteers will participate in the trial Eligible participants who have provided consent will be asked to attend 5 clinic visits in a fasted state At each visit hey will be given 1 set of waffles to eat that contains either 0g 2g 4g or 6g of barley β-glucan 7 finger pokes to collect capillary blood 5 questionnaires about their appetite and a questionnaire about the acceptability of the quick bread Each visit will last approximately 25h and be separated by 3-14 days
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