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

University of Guelph

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Resistant Starch

Study type: Interventional

Funder types: Other

Identifiers

NCT02129946

13MY041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 2 patient groups, including a placebo group

Resistant Starch Bagels

Active Comparator group

Description:

Bagels made from high-resistant starch flour (provides 24g resistant starch per day)

Treatment:

Other: Resistant Starch

Control Bagels

Placebo Comparator group

Description:

Bagels made from wheat flour

Treatment:

Other: Resistant Starch