NCT02367989

Effects of Barley on Glucose Control

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: St. Boniface Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed description

A double-blind, randomized, controlled, cross-over study designed to examine the PPGR to barley β-glucan will be conducted at the I.H. 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 2.5h and be separated by 3-14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	0g barley β-glucan no fibre	Food containing no barley β-glucan and no additional fibre
DIETARY_SUPPLEMENT	2g barley β-glucan	Food containing low amounts of barley β-glucan
DIETARY_SUPPLEMENT	4g barley β-glucan	Food containing medium amounts of barley β-glucan
DIETARY_SUPPLEMENT	6g barley β-glucan	Food containing high amounts of barley β-glucan
DIETARY_SUPPLEMENT	0g barley β-glucan with fibre	Food containing no barley β-glucan, but matches fibre content in β-glucan treatments

Timeline

• Start date: 2017-11-08
• Primary completion: 2018-08-29
• Completion: 2025-01-01
• First posted: 2015-02-20
• Last updated: 2024-11-29

Locations

1 site across 1 country: Canada