Glycemic Response of a Commercial Food Bar

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the glucose and insulin response to a food bar.

Detailed Description
-----------------
Fitjoy is a commercially available food bar marketed as having a low glycemic index and being relatively high in dietary fiber. The fiber contained within this product is isomalto-oligoshaccaride (IMO) which is a food ingredient with a relative sweetness level equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with alpha - (1-6) - linkages. To date, no research has been performed on the glycemic response to ingesting IMO in combination with other constituents. Therefore the purpose of this study is to determine the glycemic index of the Fitjoy bar.

Official Title
-----------------
Pharmacokinetic and Glycemic Response of a Commercially Available Food Bar

Conditions
-----------------
Glucose and Insulin Response

Intervention / Treatment
-----------------
* Dietary Supplement: Commercially Available Food Bar
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is between the ages of 18 and 35 Participant is apparently healthy Participant is moderately active and participants in low intensity recreational activity at lease 3 to 4 days a week Participant has a BMI < 24.9 Exclusion Criteria: Participant has a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmais, cardiovascular disease Participant uses current prescription medication (birth control is allowed) Participant is pregnant or nursing or plans to become pregnant during the next month Participant has an intolerance to caffeine and/or other natural stimulants Participant has a history of smoking Participant drinks excessively (i.e., 12 drinks per week or more)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized, cross-over administration of supplements with approximately 5-10 days between testing sessions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercially Available Food Bar<br>62 g. Fitjoy Bar | Dietary Supplement: Commercially Available Food Bar<br> <br> * Other names: Fitjoy Bar;|
| Placebo Comparator: Placebo<br>25 g. Dextrose | Dietary Supplement: Placebo<br> <br> * Other names: Dextrose Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How a commercially available food bar affects blood glucose levels | Measured in mmol/L | One day | 
| How a commercially available food bar affects blood insulin levels. | Measured in U/mL | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does a commercially available food bar cause hypoglycemia | Subjective questionnaire | One day | 
| Does a commercially available food bar cause dizziness | Subjective questionnaire | One day | 
| Does a commercially available food bar cause headaches | Subjective questionnaire | One day | 
| Does a commercially available food bar cause fatigue | Subjective questionnaire | One day | 
| Does a commercially available food bar cause stomach upset | Subjective questionnaire | One day |