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

May 2, 2018 updated by: Alison Duncan, University of Guelph

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Guelph, Ontario, Canada, N1G 2W1
        • Human Nutraceutical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Resistant Starch Bagels
Bagels made from high-resistant starch flour (provides 24g resistant starch per day)
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.
Other Names:
  • RS bagels
PLACEBO_COMPARATOR: Control Bagels
Bagels made from wheat flour
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.
Other Names:
  • RS bagels

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 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.
Day 1 and 57 of both treatment periods
Calculated insulin sensitivity and beta-cell function
Time Frame: 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.
Days 1 and 57 of both treatment periods
Satiety-producing effect
Time Frame: 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.
Day 2,3 or 4 of both treatment periods

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory response to study bagels
Time Frame: 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.
Days 15, 29, 43 and 57 of both treatment periods
Resistant starch bagel tolerance
Time Frame: 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).
Days 15, 29, 43 and 57 of both treatment periods
Body weight
Time Frame: Days 1, 15, 29, 43 and 57 of both treatment periods
Body weight will be measures at every study visit.
Days 1, 15, 29, 43 and 57 of both treatment periods
Fasting serum lipids
Time Frame: 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.
On days 1 and 57 of both treatment periods
3-Day food records
Time Frame: 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.
Over 3 days during the week before the study start date, and the week before study day 29 of both treatment periods.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guelph

Collaborators

Ontario Ministry of Agriculture, Food and Rural Affairs
Maple Leaf Foods, Canada Bread

Investigators

  • Principal Investigator: Alison M Duncan, Ph.D., R.D., University of Guelph, Human Nutraceutical Research Unit
  • Study Director: Alison M Duncan, Ph.D., R.D., University of Guelph, Human Nutraceutical Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (ESTIMATE)

May 2, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13MY041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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