The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Other: Resistant Starch
- Registration Number
- NCT02129946
- Lead Sponsor
- University of Guelph
- Brief Summary
The purpose of this study is to determine if consumption of bagels made with resistant starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.
- Detailed Description
Using a randomized, double-blind crossover study design, we will determine the effect of consuming bagels made with resistant starch daily for 8-weeks can reduce the risk of type 2 diabetes and colon cancer in an adults who are at an increased risk for type 2 diabetes. Additionally, we will compare the satiating effect of these bagels to that of a standard bagel.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Males and postmenopausal females at least 40 year old
- BMI ≥25 and <40 kg/m2
- Waist circumference ≥ 102 cm for men, ≥88cm for women
- CANRISK score ≥21 which indicates an elevated risk for type 2 diabetes
- Diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L)
- Restrained eating habits
- Gastrointestinal conditions (Celiac's disease, Crohn's disease, Ulcerative Colitis, Inflammatory Bowel Disease)
- Renal Conditions
- Hepatic Conditions
- Surgery or major medical event within 3 months of study start date
- Select medication use (Glycemia medications, cholesterol-lowering agents, antibiotics within 6 months of the study, other medications known to influence blood glucose insulin, cholesterol, triglycerides, incretin hormones of the digestive tract microbiome)
- Select natural health product (NHP) use (Phytosterols or phytosterol functional foods, other NHPs intended for glycemic or cholesterol control)
- Gluten allergy or intolerance
- Alcohol consumption >15 drinks/week for men and >10 drinks/week for women
- Significant international travel within 6 months of the starting the study, or plans to travel internationally during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control Bagels Resistant Starch Bagels made from wheat flour Resistant Starch Bagels Resistant Starch Bagels made from high-resistant starch flour (provides 24g resistant starch per day)
- Primary Outcome Measures
Name Time Method Fasting and postprandial blood glucose up to day 57 of both treatment periods Blood glucose will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods.
Fasting and postprandial insulin up to day 57 of both treatment periods Circulating insulin will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods.
- Secondary Outcome Measures
Name Time Method HbA1c Day 1 and 57 of both treatment periods HbA1c (glycated haemoglobin) will be measured from fasting blood drawn on days 1 and 57 of both treatment periods.
Calculated insulin sensitivity and beta-cell function Days 1 and 57 of both treatment periods Data will be used from 3-hour oral glucose tolerance tests performed on days 1 and 57 of both treatment periods.
Satiety-producing effect Day 2,3 or 4 of both treatment periods After study bagel consumption as part of a standard breakfast, questionnaires will be used to quantify subjective measures of satiety, and weighted food records will be used to objectively measure food intake for the rest of the day.
Trial Locations
- Locations (1)
Human Nutraceutical Research Unit
🇨🇦Guelph, Ontario, Canada