Clinical trial NCT04820322: Comparison of the Postprandial Glycemic and Insulinemic Response After a Fibersym Containing Cookie With a Control
Official title: Comparison of Postprandial Glycemic and Insulinemic Response to a Cookie With or Without Added Fibersym After Three Days of Pre-feeding: An Acute Double-blind, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Lead sponsor: MGP Ingredients, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Glycemic Index Laboratories, Inc
First posted: 2021-03-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double blind, controlled, cross-over clinical trial
Primary purpose: OTHER

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.

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 and be given a copy of the consent form which they may either sign then, take away to sign at a later date, or decline to participate. Participants were encouraged to ask any questions they may have and not to sign the consent form until all of their questions have been answered to their satisfaction. Those who consented to participate came to the research centre for a pre-selection visit when subject eligibility will be determined. A number of parameters were assessed including blood pressure, weight, height, BMI, and brief medical history.

Visit 2-3: Each eligible subject received one of the treatments at visit 2 and the other at visit 3. The order of the 2 treatments was randomized using an online randomization calculator. The interval between visits was no less than 6 days and no more than 4 weeks. Prior to each visit there was a 3-day pre-feeding period during which subjects consumed either 108.9g Control Cookies (approx. 3.5 cookies) per day or 136.2 g of Fibersym Cookies (approx. 4 cookies) per day (delivering 29 g fiber from Fibersym/day) according to the randomized order. Cookies were consumed with each main meal (breakfast, lunch and dinner).

Subjects were provided with a calorie appropriate, standard frozen dinner to be consumed on the evening before each visit. On the day of each visit, participants came to GI Labs in the morning after a 10-12 h overnight fast (except for water). Two (2) fasting fingerprick blood samples were collected at -5 min and 0 min. Each sample consisted of 2 vials, one for glucose analysis and one for insulin analysis (4-8 drops of blood each). Questionnaires to record satiety and GI symptoms were administered. Participants were then a 40g available carbohydrate protion of the same type of cookie (Control or Fibersym) they had been consuming over the past 3 days containing together with 250 ml of water and instructed to consume them over 15 minutes. Additional blood samples were collected 15, 30, 45, 60, 90 and 120 min after the start of the test meal. Satiety questionnaires were administered at the same time intervals. GI symptom questionnaires were filled out at 2 h in addition to fasting.

Test Foods:

The sugar snap cookie formula (Control) was obtained from the American Institute of Baking (AIB) International (Manhattan, KS). Fibersym RW (Appendix 1) was added as an extra portion to the Control Cookie recipe, amounts were adjusted so that both the control and Fibersym cookie portions contained the same amount of available carbohydrate (ingredients are listed in appendix 1). Both cookies were baked at the facilities of AIB. The macronutrient composition of baked cookies was determined by an independent laboratory and the final weights of the cookies fed were adjusted accordingly.

To maintain blinding, the cookies were 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 (if needed). Study Product Intake Logs were completed upon dispensation of study product to each subject. After the data had been entered, checked for errors and the database locked, the code was broken.

Participants were asked to maintain stable dietary and activity habits throughout their participation and to refrain from drinking alcohol and from unusual levels of food intake or physical activity for 24 h before each test. Subjects were asked to complete a 3- day record of supplement consumption and whether they consumed the standard evening meal, in addition to a 3-day symptom diary before each test visit. If any subject was not feeling well or had not complied with the preceding experimental conditions, the test was not carried out and was rescheduled for another day.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: 2-hour Postprandial Glucose Incremental Area Under the Curve (IAUC)
timeFrame: 2 hours
Secondary outcomes:
measure: 2-hour Postprandial Insulin Incremental Area Under the Curve (IAUC)
timeFrame: 2 hours
measure: Abdominal Bloating
timeFrame: 4 days
measure: Belching
timeFrame: 4 days
measure: Nausea
timeFrame: 4 days
measure: Diarrhea
timeFrame: 4 days
measure: Flatulence
timeFrame: 4 days
measure: Satiety Scores
timeFrame: 2 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc
state: Ontario
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas MS Wolever, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.