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Trial record 33 of 318 for:    colon cancer | ( Map: Canada )

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

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ClinicalTrials.gov Identifier: NCT02129946
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Ontario Ministry of Agriculture, Food and Rural Affairs
Maple Leaf Foods, Canada Bread
Information provided by (Responsible Party):
Alison Duncan, University of Guelph

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Resistant Starch Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

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 Name: 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 Name: RS bagels




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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).

  3. Body weight [ Time Frame: Days 1, 15, 29, 43 and 57 of both treatment periods ]
    Body weight will be measures at every study visit.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129946


Locations
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Canada, Ontario
Human Nutraceutical Research Unit
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
Ontario Ministry of Agriculture, Food and Rural Affairs
Maple Leaf Foods, Canada Bread
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alison Duncan, Alison Duncan, Ph.D., R.D., Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT02129946     History of Changes
Other Study ID Numbers: 13MY041
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by Alison Duncan, University of Guelph:
Type 2 Diabetes
Resistant Starch
Postprandial Glucose
Postprandial Insulin
Satiety
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases