Clinical trial NCT02129946: The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes
Resistant Starch
Postprandial Glucose
Postprandial Insulin
Satiety
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Agriculture, Food and Rural Affairs
name: Maple Leaf Foods, Canada Bread
First posted: 2014-05-02
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting and postprandial blood glucose
timeFrame: up to day 57 of both treatment periods
measure: Fasting and postprandial insulin
timeFrame: up to day 57 of both treatment periods
Secondary outcomes:
measure: HbA1c
timeFrame: Day 1 and 57 of both treatment periods
measure: Calculated insulin sensitivity and beta-cell function
timeFrame: Days 1 and 57 of both treatment periods
measure: Satiety-producing effect
timeFrame: Day 2,3 or 4 of both treatment periods
Other outcomes:
measure: Sensory response to study bagels
timeFrame: Days 15, 29, 43 and 57 of both treatment periods
measure: Resistant starch bagel tolerance
timeFrame: Days 15, 29, 43 and 57 of both treatment periods
measure: Body weight
timeFrame: Days 1, 15, 29, 43 and 57 of both treatment periods
measure: Fasting serum lipids
timeFrame: On days 1 and 57 of both treatment periods
measure: 3-Day food records
timeFrame: Over 3 days during the week before the study start date, and the week before study day 29 of both treatment periods.
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit
state: Ontario
Study officials:
affiliation: University of Guelph, Human Nutraceutical Research Unit
name: Alison M Duncan, Ph.D., R.D.
role: STUDY_DIRECTOR
affiliation: University of Guelph, Human Nutraceutical Research Unit
name: Alison M Duncan, Ph.D., R.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dainty SA, Klingel SL, Pilkey SE, McDonald E, McKeown B, Emes MJ, Duncan AM. Resistant Starch Bagels Reduce Fasting and Postprandial Insulin in Adults at Risk of Type 2 Diabetes. J Nutr. 2016 Nov;146(11):2252-2259. doi: 10.3945/jn.116.239418. Epub 2016 Oct 12.