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

Study Overview
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Brief Summary
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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
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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: Eligible subjects were randomized using an online randomization calculator. Eligible subjects were studied on 2 separate days over a period of 6 weeks or less. Prior to each test meal, they were provided with enough cookies to consume 3 times/day over 3 days and instructed to start consuming the cookies 3 days before their visit. They were also provided with a calorie appropriate, standard frozen dinner to be consumed on the evening before their test meal. The interval between successive tests was no less than 6 days and no more than 4 weeks. On each test day, participants came to GI Labs in the morning after a 10-12 h overnight fast (except for water). 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. Before the start of the test meal, subjects were asked whether they consumed the provided cookies over the last 3 days as instructed and the standard dinner the evening before. 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. On each test day, two 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 given the test food 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. For the test breakfasts during the postprandial visit, the subject consumed approximately 3 cookies containing 40 g available carbohydrates, the weight of Control Cookies per meal was 78.1g whereas the weight of Fibersym Cookies per meal was 97.8 g (delivering 21 g of fiber from Fibersym and 2.1g from the flour) (Table 1). Both test meals were consumed with 250 ml of water. During the 3-day pre-feeding period, subjects consumed 108.9g cookies (approx. 3.5) of Control Cookies per day and 136.2 g of Fibersym Cookies (approx. 4) per day (delivering 29 g fiber from Fibersym/day). The cookies were consumed during the 3 meals (breakfast, lunch and dinner). Both the control and Fibersym cookies contributed 50g available carbohydrate per day. 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 (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, #149 corresponded to the control cookie while 394 corresponded to the Fibersym cookie. All subjects were asked to consume a standard evening meal provided by GI Labs and consisted of a frozen dinner.

Official Title
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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

Conditions
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Postprandial Hyperglycemia

Intervention / Treatment
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* Other: Fibersym
* Other: Control cookie


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: double blind, controlled, cross-over clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control cookie<br>a sugarsnap cookie baked specifically for this trial | Other: Control cookie<br>* control cookie<br>|
| Active Comparator: Fibersym cookie<br>a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added | Other: Fibersym<br>* RS4-type resistant modified wheat starch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hour postprandial glucose incremental area under the curve (IAUC) | 2-hour postprandial glucose incremental area under the curve (IAUC) after the Fibersym-containing carbohydrate load with the control meal | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hour postprandial insulin incremental area under the curve (IAUC) | compare the 2-hour postprandial insulin incremental area under the curve (IAUC) after the Fibersym-containing carbohydrate load with the control meal | 2 hours | 
| Blood glucose concentration at each time point | To compare the individual blood glucose concentrations at each time point after the Fibersym-containing carbohydrate load with those after the control meal | 2 hours | 
| Blood glucose increment at each time point | To compare the individual blood glucose increments at each time point after the Fibersym-containing carbohydrate load with those after the control meal | 2 hours | 
| Serum insulin concentration at each time point | To compare the individual serum insulin concentrations at each time point after the Fibersym-containing carbohydrate load with those after the control meal | 2 hours | 
| Serum insulin increment at each time point | To compare the individual serum insulin increments at each time point after the Fibersym-containing carbohydrate load with those after the control meal | 2 hours | 
| Abdominal bloating | To compare the occurrence of abdominal bloating (none, mild, moderate or severe) after the three days of pre-feeding of Fibersym cookies with the control meal | 2 hours | 
| Belching | To compare the occurrence of belching (none, mild, moderate or severe) after the three days of pre-feeding of Fibersym cookies with the control meal | 2 hours | 
| Nausea | To compare the occurrence of nausea (none, mild, moderate or severe) after the three days of pre-feeding of Fibersym cookies with the control meal | 2 hours | 
| Diarrhea | To compare the occurrence of diarrhea (none, mild, moderate or severe) after the three days of pre-feeding of Fibersym cookies with the control meal | 2 hours | 
| Flatulence | To compare the occurrence of flatulence (none, mild, moderate or severe) after the three days of pre-feeding of Fibersym cookies with the control meal | 2 hours | 
| Satiety scores | To compare the satiety scores after the Fibersym-containing carbohydrate load with the control meal. Satiety is the mean of 4 measures, hunger, fullness, desire to eat and prospective consumption (how much do you think you can eat) each measured using visual analogue scales (VAS) at intervals over the postprandial period. A VAS is a 100mm line anchored at the left end with phrase indicating a high in tensity of the feeling (eg. as hungry as I have ever felt) and at the other end with a phrase indicating a low intensity of feeling (eg. not hungry at all). A lower score means that the subject is more satiated. | 2 hours |