An interventional study of 0g barley β-glucan no fibre and 2g barley β-glucan in Healthy, sponsored by St. Boniface Hospital. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by St. Boniface Hospital · Not applicable, Interventional, and Prevention
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:
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.
St. Boniface Hospital is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention: 0g barley β-glucan no fibre. Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary Supplement: 0g barley β-glucan no fibre
Intervention: 2g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary Supplement: 2g barley β-glucan
Intervention: 4g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary Supplement: 4g barley β-glucan
Intervention: 6g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary Supplement: 6g barley β-glucan
Intervention: 0g barley β-glucan with fibre Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary Supplement: 0g barley β-glucan with fibre
Food containing no barley β-glucan and no additional fibre
Food containing low amounts of barley β-glucan
Food containing medium amounts of barley β-glucan
Food containing high amounts of barley β-glucan
Food containing no barley β-glucan, but matches fibre content in β-glucan treatments
Post-prandial glucose response
Incremental area under the curve for glucose (mmol\*min/L)
Time frame: 120 minutes
Post-prandial insulin response
Incremental area under the curve for insulin (uIU\*min/mL)
Time frame: 120 min
hunger
total area under the curve (AUC) using visual analog scales
Time frame: 120 min
fullness
total area under the curve (AUC) using visual analog scales
Time frame: 120 min
desire to eat
total area under the curve (AUC) using visual analog scales
Time frame: 120 min
prospective consumption
total area under the curve (AUC) using visual analog scales
Time frame: 120 min
Acceptability of waffle color
Ratings on a scale of 1-9
Time frame: 15 min
Acceptability of waffle aroma
Ratings on a scale of 1-9
Time frame: 15 min
Acceptability of waffle flavor
Ratings on a scale of 1-9
Time frame: 15 min
Acceptability of waffle texture
Ratings on a scale of 1-9
Time frame: 15 min
Acceptability of waffle frequency of consumption
Ratings on a scale of 1-9
Time frame: 15 min
Gastrointestinal side effects
self reporting incidence of gastrointestinal effects
Time frame: 120 min
Plan to share: No
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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St. Boniface Hospital