CLINICAL PROTOCOL

Clinical research was conducted by Glycemic Solutions at the University In Vivo Testing Facility to determine the metabolic response of Popcorn Marketing’s Blue Agave Nectar, (herein the “Test Food”), in human diabetics. The Test Food was prepared and fed to the subjects, and cross analyzed against other brands of similar products. Bread Average Area Under the Curve (AUC) and Test Food AUC were analyzed from serum readings and converted to the Glucose Scale.

OBJECTIVE

To determine the glycemic index and glycemic load associated with human ingestion of the Test Food.

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BOARD APPROVAL

This research was performed under the direction of medical physicians utilizing Glycemic Research Institute Standardized Protocols, submitted to the U.S. Government by GRI and approved by the Independent Institutional Review Board of Florida, University of Florida.

GRI Board Approved In Vivo clinical protocols were utilized in order to determine the glycemic index, glycemic load, and acceptability of the product tested.

Clinical testing was conducted under the direction of the GRI’s Medical Advisory Board, M.D.’s, and statisticians. Testing methods were approved by Independent Institutional Review Boards for the State of Florida. Specific analytical testing methods are the property of GRI.

TEST FOOD SERVING SIZE

Legal use of the term “Low Glycemic” in the United States, as dictated by the Federal government, requires “appropriate serving size” amounts used in clinical tests. Appropriate serving sizes were utilized during this clinical study.

TEST FOOD

The Test Foods analyzed during this clinical trial are as follows:

(1)     Popcorn Marketing’s Blue Agave Nectar

ANALYSIS DIRECTIVE

The glycemic index, glycemic load, and overall glycemic response in humans were analyzed during this clinical study. The Test Food was fed to human subjects comprised of diabetics.

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METHODS

Ten human subjects are typically used in each product tested. White bread (with standardized GI) is used as the standard. Each subject is fed a minimum of three bread standards for comparison to the products tested. Calculations are made using the area under the curve (AUC) as compared to bread standards (converted to the glucose scale). AUC is calculated by GRI statisticians using standard GRI protocols.

GLYCEMIC INDEX

The glycemic index (GI) is determined In Vivo utilizing GRI standardized clinical protocols. The glycemic potential of each carbohydrate (including sugar alcohols) corresponds to the measure of the triangular surface of the hyperglycemic curve induced by carbohydrate ingestion. Glucose, given an index of 100, represents the triangular surface of the corresponding hyperglycemic curve. The GI of other carbohydrates, therefore, is calculated by the following formula:

Triangular surface of tested carbohydrate

--------------------------------------------------     x  100

Triangular surface of glucose

The GI rises according to the level of hyperglycemia. The higher the GI, the higher the hyperglycemia induced by the carbohydrate.

LOW-CARBOHYDRATE and NON-CARBOHYDRATE FOODS

Utilizing standardized GRI Board-Approved clinical protocols, accommodations are made for low-end carbohydrate products. Test foods that contain little-or-zero carbohydrates (including pure protein) are analyzed according to their glycemic and fat-storing properties. Statistical analysis based on blood drawn differs from that of carbohydrate-rich test foods.

High protein foods with little or no carbohydrate typically elicit a higher glycemic response in humans.

www.GlycemicIndexTesting.com

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CLINICAL RESULTS

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SUBJECTS:                                     10 DIABETIC HUMANS

Test Food:                                       (1) Blue Agave Nectar

Delivery:                                           Test Food consumed orally

Test Food Preparation:                     Served alone; room temperature

Servings Per Subject:                One serving of (1) teaspoon (5 ml)

                                                One serving of (2) teaspoons (10 ml)

                                                One serving of (3) teaspoons (15 ml)                            

Carbohydrates Per Feeding:       One serving (6.0 grams) 
                                                 Two servings (12.0 grams)

                                                 Three servings (18.0 grams)

GLYCEMIC INDEX                    LOW GLYCEMIC

27.0 on glucose scale                    per 1, 2, and 3 servings

GLYCEMIC LOAD                     LOW GLYCEMIC LOAD

1.6                                               per 1, 2, and 3 servings

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CLINICAL ASSESSMENT

STUDY CONDUCTED FOR:        Popcorn Marketing

             Blue Agave Nectar (1)

GLYCEMIC STATUS

In human diabetic subjects, at the Test Doses, the Blue Agave Nectar (the Test Food) was determined to be Low Glycemic with a Low Glycemic Load.

GASTROINTESTINAL PROFILE

No reports of gastrointestinal distress were noted after consumption of the Test Food.

LOW GLYCEMIC GUIDELINES

The Blue Agave Nectar Test Food passed the clinical protocols for “Low Glycemic” foods  as required by FDA and FTC guidelines, and as specified by Standardized Clinical Testing Protocols accepted in the United States and worldwide. 

GLYCEMIC INDEX QUALIFICATIONS

·        Per Accepted World Health Organization

·        Both the GI and the GL must be low to qualify as Low Glycemic

Low GI                 55 or less

High GI                70 +

Low GL                10 or less

High GL               20 +

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