Barley β-Glucan for Glucose Control

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Boniface Hospital

Must not be taking: Corticosteroids, Stomach acid-lowering, Laxatives, others

Disqualifiers: Diabetes, Cardiovascular disease, Liver disease, others

Compensation: Varies

Number of Visits: 5

Duration: 5 visits over 3-14 days each

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Heather Blewett, PhD

Principal Investigator

Agriculture and Agri-Food Canada

Eligibility Criteria

This trial is for generally healthy men and women aged 18-40 with a BMI of 18.5-30 who regularly eat three meals a day. Participants must be willing to give informed consent and follow the study's requirements.

Inclusion Criteria

Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively;

Willing to provide informed consent;

Body mass index (BMI) 18.5-30.0 kg/m2

Exclusion Criteria

I have a history of heart disease.

I have not had major surgery in the last 3 months.

My fasting HDL cholesterol is below 0.9 mmol/L.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 5 clinic visits in a fasted state to consume waffles with varying doses of barley β-glucan and undergo blood tests and questionnaires

5 visits over 3-14 days each

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Barley β-glucan

Trial Overview The trial is testing how different doses of barley β-glucan (0g, 2g, 4g, and 6g) in waffles affect blood sugar levels after eating. It's designed as a cross-over study where participants will try each dose to see which one works best at controlling glucose and insulin response.

Participant Groups

Group I: medium barley β-glucan Experimental Treatment 1 Intervention

Intervention: 4g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.

Group II: low barley β-glucan Experimental Treatment 1 Intervention

Intervention: 2g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.

Group III: high barley β-glucan Experimental Treatment 1 Intervention

Intervention: 6g barley β-glucan Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.

Group IV: control with fibre Placebo Group 1 Intervention

Intervention: 0g barley β-glucan with fibre Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.

Group V: Control without fibre Placebo Group 1 Intervention

Intervention: 0g barley β-glucan no fibre. Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.

Who Is Running the Clinical Trial?

St. Boniface Hospital

Lead Sponsor

Trials

55

Recruited

15,000+

Agriculture and Agri-Food Canada

Collaborator

Trials

35

Recruited

2,300+