Type 2 Diabetes MellitusNCT02129946
The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer
A study testing Resistant Starch in people with Type 2 Diabetes Mellitus, run by University of Guelph at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Resistant Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Resistant Starch
- Keywords
- Type 2 Diabetes, Resistant Starch, Postprandial Glucose, Postprandial Insulin, Satiety
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant StarchOther
Also called RS bagels
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistant Starch Bagels | Active comparator | Bagels made from high-resistant starch flour (provides 24g resistant starch per day) Receives: Other: Resistant Starch |
| Control Bagels | Placebo comparator | Bagels made from wheat flour Receives: Other: Resistant Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to day 57 of both treatment periods
Secondary outcomes (3)
HbA1c
HbA1c (glycated haemoglobin) will be measured from fasting blood drawn on days 1 and 57 of both treatment periods.
Measured: Day 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.
Measured: 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.
Measured: Day 2,3 or 4 of both treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs, Maple Leaf Foods, Canada Bread
- Responsible party
- Principal investigator, Alison Duncan, University of Guelph
- Investigators
- Alison M Duncan, Ph.D., R.D., Study director, University of Guelph, Human Nutraceutical Research UnitAlison M Duncan, Ph.D., R.D., Principal investigator, University of Guelph, Human Nutraceutical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129946
- Sponsor's protocol ID
- 13MY041
- Status last verified
- May 2018
- First submitted
- 29 Apr 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27733521
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02129946
- Acronym / sponsor ID
- 13MY041
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes, Resistant Starch, Postprandial Glucose, Postprandial Insulin, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs, Maple Leaf Foods, Canada Bread
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant Starch Bagels | Active comparator | Other: Resistant StarchBagels made from high-resistant starch flour (provides 24g resistant starch per day) |
| Control Bagels | Placebo comparator | Other: Resistant StarchBagels made from wheat flour |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant StarchAlso: RS bagelsIn 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 | Control Bagels, Resistant Starch Bagels |
Primary outcome
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.
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.
3 secondary outcomes
HbA1c
Time frame: 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
Satiety-producing effect
Time frame: Day 2,3 or 4 of both treatment periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 27733521Dainty 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison M Duncan, Ph.D., R.D. study director
University of Guelph, Human Nutraceutical Research Unit
Alison M Duncan, Ph.D., R.D. principal investigator
University of Guelph, Human Nutraceutical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Starch in people with Type 2 Diabetes Mellitus, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting and postprandial blood glucose (time frame: up to day 57 of both treatment periods). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.