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Glycemic Research Institute

At GRI, we are proud to be a professional clinical research and development organization specializing in glycemic index testing for over 30 years. Our expertise lies in FDA and FTC legal glycemic index claims. We work closely with manufacturers to clearly identify these claims on labels.

Claim Substantiation For:

Foods

Meals

Prepared Foods Nutraceuticals

Pharmaceuticals and Products in Development

We are proud to be

Serving the largest food & research companies in the world

Board Approved Human In-Vivo Clinical Trials

Low Glycemic Index product substantiation

Metabolic identity of sugars and sweeteners substantiation

"Having a well controlled clinical trial is like having money in the bank"

July 2008 Diabetes Forecast
American Diabetes Association

Avoid FDA Action Against Illegal Glycemic Label Claims.

For information on Glycemic Index and
Glycemic Load Defined, click View More:

Federal Government Guidelines

Glycemic Research Institute

Federal Government Guidelines for

Authorized Certification Marks

Safety Guidelines for Test(s)

Glycemic Research Institute

Client Responsibility
Safety Guidelines for Test Food(s) Being Submitted for Clinical Trails

More About Who We Are

More About Who We Are

Glycemic Research Institute

Glycemic Research Institute conducts human In Vivo clinical studies, which is the only legal product claim substantiation accepted by the United States government, including the FDA & FTC.

Laws in the United States dictate that all glycemic index claims made by food or dietary supplement products require substantiation via human clinical trials (In Vivo). Documentation demonstrating the validity of clinical evidence for said claims is required by the Federal government.

Glycemic Research Institute clinical trials are approved by the appropriate Review Boards, and include diabetics, non-diabetics, overweight, and obese subjects.

Glycemic Research Institute conducts clinical glycemic index testing for clients in the United States, and worldwide.

Glycemic Research Institute has the highest rate of accuracy available, with specific in-real-time analytical testing methods. The typical accuracy of GI testing has a variable of 80 percent. GRI accuracy has a variable of < 2 percent.

Glycemic Research Institute clinical studies include various glycemic index protocols suited to the clients needs, including studies utilizing diabetics, non-diabetics, obese, and overweight subjects. GRI can determine clinically if the product submitted:

Is shunted into and/or stored in adipose tissue fat cells (is fattening)
Exacerbates hypoglycemia, diabetes, and insulin resistant disorders
Is acceptable for diabetics to consume
Over-elevates blood glucose or insulin levels
Affects sports performance in athlete

CLIENT LISTING
Glycemic Research Institute

The following products have been submitted to the Glycemic Research Institute for Human In-Vivo Clinical Trials. This is a short list of products submitted to Glycemic Research Institute for Board Approved Human In Vivo Clinical Trials.

Glycemic Research Institute

Internationally Accredited Testing
&

Certification Organization

Glycemic Research Institute

Human Nutrition & Biochemistry Division

Glycemic Index & Load Clinical Trials
Obesity Research & Clinical Trials
Diabetes Research & Clinical Trials
Adipose Fat Storage Investigations & Trials
Human In Vivo Clinical Trials Laboratory
Department of Dietary Supplements
Department of Foods & Beverages
Department of Pharmaceuticals
Childhood Obesity UnitClinical Investigations &Trials Laboratory

Sports Physiology Laboratory
Department of Biological Circuitry
Department of Sports Performance
Sports Supplements & Sports Drinks
Clinical Investigations & Trials Laboratory

Food Addictions Laboratory
Department of Neuroscience
Cephalic Research Unit
Department of Brain Glycemic Indexing
Metabolic Identity of Sugars and Sweeteners

Certification
Programs

The Glycemic Research Institute is an Internationally Accredited Testing & Certification Organization approved by International Governments, including the United States government.

The Glycemic Research Institute Certification Program and Certification Programs are Registered, Authorized, and Licensed by the United States, Canada, and United Kingdom governments, and accepted Worldwide per World Health Organization (WHO) Guidelines.

The Glycemic Research Institute government-issued Certification Marks represent 25-years of Clinical Research in the fields of the Glycemic Index, Diabetes, Cephalic Response, Obesity, Adipose Tissue Fat-Storage, and Childhood Obesity.

The Glycemic Research Institute Certification Marks are legally authorized to make a clinical statement, such as “LOW GLYCEMIC” or ‘DIABETIC FRIENDLY” or “LOW CEPHALIC INDEX” or “KID FRIENDLY” or “NATURAL BEVERAGE” on an FDA label for a commercial food, Nutraceutical, beverage, or Pharmaceutical product.

Any Certification Mark statement representing a clinical claim must be backed by Human In Vivo Clinical Trials per FDA CFR 21 guidelines and per the Clinical Trials Guidelines submitted by the organization licensed to use said Certification Mark.

A Certification Mark on a commercial product legally enables bounding (being under legal obligation) under the following guidelines:

The existence of a Legal Product Certification Agreement between the manufacturer of a product and the organization that possesses accreditation by a national government for both testing and product certification.
Legal evidence that the product was successfully tested in accordance with a nationally accredited standards.
Legal assurance the accredited certification organization has ensured that the item that was successfully tested, and is identical to that which is being offered for sale.
Legal assurance that the successful test has resulted in a certification listing, which is considered public information, which sets out the tolerances and conditions of use for the certified product, to enable bounding, and thus compliance with the law.
Legal assurance that the manufacturer is being regularly audited by the Certification Organization, at unannounced intervals, to ensure the maintenance of the original process standard that was employed in the manufacture of the test specimen that passed the test, and that if the manufacturer should fail an audit, all product certification, including labels of stock on hand, on construction sites, with end-user customers and on distributor store shelves, shall be immediately removed, and all stakeholders will be informed that the de-listed product certification is no longer eligible for use in bounding.

Quality Assurance

The Legal

Relationship Between

Certifier & Client

Product certification and product qualification is the cornerstone of all bounding for Certification Marks, and the process of certifying that a specific product has passed performance and quality assurance tests or qualification requirements stipulated in regulations and Nationally Accredited Test Standards, and that a product complies with a set of regulations governing quality and/or minimum performance requirements.

On the part of the certifier, in this case, the Glycemic Research Institute® (GRI), is certifying that a product has passed all Clinical Protocols established to use the Glycemic Research Institute® Certification Marks on a label and/or product marketing materials, including websites.

For products that pass the strict Clinical Protocol, the Glycemic Research Institute® allows the use the GRI Mark on the product label, thus indicating legal eligibility of the product for use in bounding, and certifies the origin, material, mode of manufacture of products, mode of performance of services, quality, and accuracy of other characteristics of the product.

Products, once certified, may be endorsed with the Authorized Certification Mark and may be eligible to display said Certification Mark, under the direction and guidelines of the Glycemic Research Institute®.

Trademarks vs
Certification Marks

Trademarks are vastly different from Certification Marks. Trademarks are issued to individuals and companies and represent a word (s) or logo used by that entity.

Certification Marks are difficult to register, and are only issued by the government to companies that are Nationally Accredited Testing and Certification Organizations.

It is difficult, lengthy, and expensive to obtain a Certification Mark from the government, as the organization applying for said Mark must prove worthiness on many different levels of competence, expertise, and good standing in the community.

Companies that are legally issued a Certification Mark must follow strict government guidelines in order to obtain, maintain and continue to use said Marks.

Example of Valid Certification Marks

The main purpose of government Certification Mark regulations is to protect consumers against misleading practices.

Some of the more commonly seen Certification Marks are:

Underwriters Laboratories holds a service mark on the phrase "UL Listed," and allows manufacturers of electrical and other safety equipment to use the UL mark only if they are under follow-up agreement by UL. This lets consumers identify products that meet quality criteria set by a company other than the manufacturer.

The Bureau Veritas Certification Mark, used to indicate

the Sea-Worthiness of Ships.

(U in a full circle), the hechsher of the Orthodox Union.

Glycemic Research Institute has been conducting Human Clinical In Vivo Trials in the field of diabetes for the past 23 years. This picture represents Nanotechnology in diabetes research.

December 2007
Research Stands Up To Intense Scrutiny

UNITED STATES
DEPARTMENT
OF DEFENSE

2008 Department of Defense BUYERS GUIDE
Authorized 2008 Supplier/Vendor:
Listing ID: 2223582873