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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Resistant Starch
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes, Resistant Starch, Postprandial Glucose, Postprandial Insulin, Satiety

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Human Nutraceutical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Resistant Starch Bagels

Control Bagels

Arm Description

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

Bagels made from wheat flour

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

HbA1c
HbA1c (glycated haemoglobin) will be measured from fasting blood drawn on days 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.
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.

Full Information

First Posted
April 29, 2014
Last Updated
May 2, 2018
Sponsor
University of Guelph
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs, Maple Leaf Foods, Canada Bread
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1. Study Identification

Unique Protocol Identification Number
NCT02129946
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs, Maple Leaf Foods, Canada Bread

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes, Resistant Starch, Postprandial Glucose, Postprandial Insulin, Satiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistant Starch Bagels
Arm Type
Active Comparator
Arm Description
Bagels made from high-resistant starch flour (provides 24g resistant starch per day)
Arm Title
Control Bagels
Arm Type
Placebo Comparator
Arm Description
Bagels made from wheat flour
Intervention Type
Other
Intervention Name(s)
Resistant Starch
Other Intervention Name(s)
RS bagels
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fasting and postprandial blood glucose
Description
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.
Time Frame
up to day 57 of both treatment periods
Title
Fasting and postprandial insulin
Description
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.
Time Frame
up to day 57 of both treatment periods
Secondary Outcome Measure Information:
Title
HbA1c
Description
HbA1c (glycated haemoglobin) will be measured from fasting blood drawn on days 1 and 57 of both treatment periods.
Time Frame
Day 1 and 57 of both treatment periods
Title
Calculated insulin sensitivity and beta-cell function
Description
Data will be used from 3-hour oral glucose tolerance tests performed on days 1 and 57 of both treatment periods.
Time Frame
Days 1 and 57 of both treatment periods
Title
Satiety-producing effect
Description
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.
Time Frame
Day 2,3 or 4 of both treatment periods
Other Pre-specified Outcome Measures:
Title
Sensory response to study bagels
Description
Questionnaires will be used to measure the participants' responses to the aroma, appearance, taste and texture of the study bagels.
Time Frame
Days 15, 29, 43 and 57 of both treatment periods
Title
Resistant starch bagel tolerance
Description
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).
Time Frame
Days 15, 29, 43 and 57 of both treatment periods
Title
Body weight
Description
Body weight will be measures at every study visit.
Time Frame
Days 1, 15, 29, 43 and 57 of both treatment periods
Title
Fasting serum lipids
Description
Total-cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides will be measured from fasted blood samples on days 1 and 57 of both treatment periods.
Time Frame
On days 1 and 57 of both treatment periods
Title
3-Day food records
Description
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.
Time Frame
Over 3 days during the week before the study start date, and the week before study day 29 of both treatment periods.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison M Duncan, Ph.D., R.D.
Organizational Affiliation
University of Guelph, Human Nutraceutical Research Unit
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alison M Duncan, Ph.D., R.D.
Organizational Affiliation
University of Guelph, Human Nutraceutical Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutraceutical Research Unit
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27733521
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.
Results Reference
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The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer

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