Effects of Barley on Glucose Control

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.

Inclusion criteria

• Generally healthy male or female, between the age of 18-40 years;
• Body mass index (BMI) 18.5-30.0 kg/m2;
• Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively;
• Willing to provide informed consent;
• Willing/able to comply with the requirements of the study.

Exclusion criteria

• Pregnant or lactating;
• Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L, HbA1c ≥6.0%, or use of insulin or oral medication to control blood sugar;
• Medical history of cardiovascular disease;
• Systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg;
• Fasting plasma total cholesterol >7.8 mmol/L;
• Fasting plasma HDL <0.9 mmol/L;
• Fasting plasma LDL >5.0 mmol/L;
• Fasting plasma triglycerides >2.3 mmol/L;
• Major surgery within the last 3 months;
• Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
• Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
• Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
• Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use with the past 6 weeks;
• Active treatment for any type of cancer within 1 year prior to study start;
• Other medical, psychiatric, or behavioral factors that in the judgment of the principal Investigator may interfere with study participation or the ability to follow the intervention protocol;
• Shift worker (a system of employment where an individual's normal hours of work are in part, outside the period of normal working day; 6am and 8pm);
• Smoking, use of tobacco or a nicotine replacement product (within the last 3 months);
• Allergies to barley or wheat flour;
• Aversion or unwillingness to eat study foods;
• Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycemia;
• Participation in another clinical trial, current or in the past 4 weeks;
• Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.