Clinical trial · Interventional
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
NCT02129946CI-TRIAL-00032829completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Type 2 Diabetes Mellitus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resistant Starch | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Resistant Starch Bagels
- description
- Bagels made from high-resistant starch flour (provides 24g resistant starch per day)
- interventionNames
- Other: Resistant Starch
- type
- PLACEBO_COMPARATOR
- label
- Control Bagels
- description
- Bagels made from wheat flour
- interventionNames
- Other: Resistant Starch
Primary outcomes (2)
- measure
- Fasting and postprandial blood glucose
- timeFrame
- up to day 57 of both treatment periods
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDainty 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 27733521