Clinical Trial

Effects of Barley on Glucose Control

Active, Not Recruiting
View on ClinicalTrials.gov →
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 Canada's 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
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2015-02-19; most recent amendment 2024-11-26.
Status change: Recruiting → Active, Not Recruiting 2019-04-02
Status change: Not Yet Recruiting → Recruiting 2017-11-09
Trial Details
NCT Number NCT02367989
Lead Sponsor St. Boniface Hospital
Collaborators: Agriculture and Agri-Food Canada
Conditions Healthy
Enrollment 24 participants
Start Date 2017-11-08
Primary Completion 2018-08-29 (estimated)
Study Completion 2025-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-29