Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes, Resistant Starch, Postprandial Glucose, Postprandial Insulin, Satiety
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.
Interventions
OTHERResistant Starch
In a randomized crossover fashion, participants will consume bagels that are made with either high-resistant starch or standard wheat flour, daily for a period of 8 weeks, with a 4 week washout period.
Sponsors
Ontario Ministry of Agriculture, Food and Rural Affairs
Maple Leaf Foods, Canada Bread
University of Guelph
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensory response to study bagels | Days 15, 29, 43 and 57 of both treatment periods | Questionnaires will be used to measure the participants' responses to the aroma, appearance, taste and texture of the study bagels. |
| Body weight | Days 1, 15, 29, 43 and 57 of both treatment periods | Body weight will be measures at every study visit. |
| Resistant starch bagel tolerance | Days 15, 29, 43 and 57 of both treatment periods | Questionnaires about bagel tolerance, including subjective ratings of tolerance and any adverse events will be completed every 2 weeks throughout both treatment periods (adverse events will be recorded as often as needed). |
| Fasting serum lipids | On days 1 and 57 of both treatment periods | Total-cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides will be measured from fasted blood samples on days 1 and 57 of both treatment periods. |
| 3-Day food records | Over 3 days during the week before the study start date, and the week before study day 29 of both treatment periods. | Participants will complete 3-day food records a total of 3 times throughout the study to provide information about their background nutrient intake and dietary habits. |
Countries
Canada
Outcome results
None listed