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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129946
• Other study ID #: 13MY041
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2018
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Resistant 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.

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit	Guelph	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Guelph	Maple Leaf Foods, Canada Bread, Ontario Ministry of Agriculture, Food and Rural Affairs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensory response to study bagels	Questionnaires will be used to measure the participants' responses to the aroma, appearance, taste and texture of the study bagels.	Days 15, 29, 43 and 57 of both treatment periods
Other	Resistant starch bagel tolerance	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).	Days 15, 29, 43 and 57 of both treatment periods
Other	Body weight	Body weight will be measures at every study visit.	Days 1, 15, 29, 43 and 57 of both treatment periods
Other	Fasting serum lipids	Total-cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides will be measured from fasted blood samples on days 1 and 57 of both treatment periods.	On days 1 and 57 of both treatment periods
Other	3-Day food records	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.	Over 3 days during the week before the study start date, and the week before study day 29 of both treatment periods.
Primary	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
Primary	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	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
Secondary	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
Secondary	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