The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Human Clinical Trial to Investigate the Effects of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer in Adults at Risk for Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Resistant Starch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resistant Starch Bagels<br>Bagels made from high-resistant starch flour (provides 24g resistant starch per day) | Other: Resistant Starch<br>* 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.<br>* Other names: RS bagels;|
| Placebo Comparator: Control Bagels<br>Bagels made from wheat flour | Other: Resistant Starch<br>* 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.<br>* Other names: RS bagels;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting and postprandial blood glucose | 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. | up to day 57 of both treatment periods | 
| Fasting and postprandial insulin | 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. | up to day 57 of both treatment periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c (glycated haemoglobin) will be measured from fasting blood drawn on days 1 and 57 of both treatment periods. | Day 1 and 57 of both treatment periods | 
| Calculated insulin sensitivity and beta-cell function | Data will be used from 3-hour oral glucose tolerance tests performed on days 1 and 57 of both treatment periods. | Days 1 and 57 of both treatment periods | 
| Satiety-producing effect | 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. | Day 2,3 or 4 of both treatment periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Satiety, Type 2 Diabetes, Resistant Starch, Postprandial Glucose, Postprandial Insulin