The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer
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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Jan 2014
Shorter than P25 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMay 8, 2018
May 1, 2018
9 months
April 29, 2014
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
HbA1c
Day 1 and 57 of both treatment periods
Calculated insulin sensitivity and beta-cell function
Days 1 and 57 of both treatment periods
Satiety-producing effect
Day 2,3 or 4 of both treatment periods
Other Outcomes (5)
Sensory response to study bagels
Days 15, 29, 43 and 57 of both treatment periods
Resistant starch bagel tolerance
Days 15, 29, 43 and 57 of both treatment periods
Body weight
Days 1, 15, 29, 43 and 57 of both treatment periods
- +2 more other outcomes
Study Arms (2)
Resistant Starch Bagels
ACTIVE COMPARATORBagels made from high-resistant starch flour (provides 24g resistant starch per day)
Control Bagels
PLACEBO COMPARATORBagels made from wheat flour
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Guelphlead
- Ontario Ministry of Agriculture, Food and Rural Affairscollaborator
- Maple Leaf Foods, Canada Breadcollaborator
Study Sites (1)
Human Nutraceutical Research Unit
Guelph, Ontario, N1G 2W1, Canada
Related Publications (1)
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.
PMID: 27733521DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alison M Duncan, Ph.D., R.D.
University of Guelph, Human Nutraceutical Research Unit
- PRINCIPAL INVESTIGATOR
Alison M Duncan, Ph.D., R.D.
University of Guelph, Human Nutraceutical Research Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Alison Duncan, Ph.D., R.D., Professor
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 2, 2014
Study Start
January 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
May 8, 2018
Record last verified: 2018-05