Skip to main content
OpenTrials
Completed

NCT Number: NCT02129946

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistant starch

Other

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 names: RS bagels

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Maple Leaf Foods, Canada Bread
  • Ontario Ministry of Agriculture, Food and Rural Affairs

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 2, 2014
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.