Status:
COMPLETED
Comparison of the Postprandial Glycemic and Insulinemic Response After a Fibersym Containing Cookie With a Control
Lead Sponsor:
MGP Ingredients, Inc.
Collaborating Sponsors:
Glycemic Index Laboratories, Inc
Conditions:
Postprandial Hyperglycemia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Fibersym® is a RS4-type resistant modified wheat starch in which over 85% of the total starch is resistant starch as measured by AOAC method 991.43. It is meant to be consumed on a regular basis and d...
Detailed Description
The study used a double-blind, randomized, cross-over design. Visit 1: Participants willing to be considered were invited to come to the research centre to have the study procedures explained to them...
Eligibility Criteria
Inclusion
- Male or non-pregnant females, 18-75 years of age, inclusive
- Body mass index (BMI) between 18.5 and 35 kg/m² inclusive at screening.
- Systolic blood pressure \<130 mm Hg; Diastolic blood pressure \<90 mm Hg.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to abstain from strenuous exercise, or consume alcoholic drinks 24 hours before study days.
- Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study Investigator.
- Female subjects; willing to use a contraceptive method to avoid pregnancy during the study period.
Exclusion
- Failure to meet any one of the inclusion criteria
- Smokers
- Known history of diabetes, gastrointestinal, liver, kidney, or cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), and pulmonary disease
- Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Use of antibiotics within 4 weeks of start of study
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- Known intolerance, sensitivity or allergy to any ingredients in the study products.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.)
- Change in body weight of \>3.5 kg within 4 weeks of the screening visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Exposure to any non-registered drug product within 30 d prior to screening.
- Pregnancy or breastfeeding
- Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional
Key Trial Info
Start Date :
August 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04820322
Start Date
August 24 2018
End Date
October 19 2018
Last Update
January 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Glycemic Index Laboratories, Inc
Toronto, Ontario, Canada, M5C 2N8