Comparison of the Postprandial Glycemic and Insulinemic Response After a Fibersym Containing Cookie With a Control

NCT04820322 | Completed Results

• 1 other identifier: GIL-1852
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 doses up to 33g/day can be tolerated. The effect of a Fibersym-containing meal on postprandial glucose and insulin levels when compared to a control meal, where both meals contain the same amount of available carbohydrate, is not known. This study therefore investigated the acute effect of a Fibersym cookie and a control cookie matched for available carbohydrate after a 3-day habituation period.

Conditions

Postprandial Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 2-hour Postprandial Glucose Incremental Area Under the Curve (IAUC)

  2-hour postprandial glucose incremental area under the curve (IAUC), calculated from blood samples taken 5 min prior to meal, 0, 15, 30, 45, 60, 90 and 120 min after the start of the test meal.

  2 hours

Secondary Outcomes (7)

• 2-hour Postprandial Insulin Incremental Area Under the Curve (IAUC)

  2 hours

• Abdominal Bloating

  4 days

• Belching

  4 days

• Nausea

  4 days

• Diarrhea

  4 days

Study Arms (2)

control cookie

PLACEBO COMPARATOR

a sugarsnap cookie baked specifically for this trial

Other: Control cookie

Fibersym cookie

ACTIVE COMPARATOR

a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added

Other: Fibersym

Interventions

Fibersym OTHER

RS4-type resistant modified wheat starch

Fibersym cookie

Control cookie OTHER

control cookie

control cookie

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MGP Ingredients, Inc.: lead
• Glycemic Index Laboratories, Inc: collaborator

Study Sites (1)

Glycemic Index Laboratories, Inc

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

• Wolever TMS, Maningat CC, Seib PA, Campbell JE, Jenkins AL. Cross-linked phosphorylated RS4 wheat starch reduces glucose and insulin responses after 3 days of pre-feeding in healthy adults: an acute, double-blind, randomized controlled clinical trial. Int J Food Sci Nutr. 2023 Sep;74(5):621-629. doi: 10.1080/09637486.2023.2236809. Epub 2023 Jul 20.

  PMID: 37475127 RESULT

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Principal Scientist
• Organization: INQUIS Clinical Research

twolever@inquis.com

4168619177

Study Officials

• Thomas MS Wolever, MD

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The product was re-packaged by a GI Labs staff member not involved in the clinical trial. Product label displayed the subject number, subject initials, product ID, ingredients statement, GIL repacked date, expiration date, researcher name and telephone number, investigational use statement, and allergy warnings. After the data had been entered, checked for errors and the database locked, the code was broken, #149 corresponded to the control cookie while 394 corresponded to the Fibersym cookie..
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: double blind, controlled, cross-over clinical trial

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 29, 2021
• Study Start: August 24, 2018
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)