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Glycemic Research Institute

Clinical Trials    

Substantiations

Certifications

A Professional Clinical Research Organization Specializing In Glycemic Index Testing with over 30 Years of Glycemic Expertise. Specializing in: FDA & FTC Legal Glycemic Index Claims (Since 1983)

 

  • Foods   

  • Meals    

  • Prepared Foods Nutraceuticals    

  • Pharmaceuticals and Products in Development​​

Serving the largest food and research companies in the world​ for

over 30 years.

Official clinical testing facility for the Glycemic Research Institute 
Board approved Human In-Vivo Clinical Trials
​​Low Glycemic Index product substantiation
​​Metabolic Identity of sugars and sweeteners substantiation

Metabolic Impact of Foods and Beverages in Humans

Low glycemic index, Diabetic response, Product substantiation, and

Clinical Trial Claims for Food & Nutraceutical Companies

The Largest Database in the world of the metabolic effect in humans

of 400+ Sugars and Sweeteners

Claim Substantiation For:

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Glycemic Research Institute

Accreditation

Certifications

Compliance

U.S. Government Accredited Certification Organization

Canada Government Accredited Certification

United Kingdom Accredited Certification

World Health Organization Compliant Guidelines

CLINICAL TRIALS LABORATORY Government Compliant Certification

Programs: FDA Claim Substantiation Clinical Trials Per FDA CFR 21 Guidelines

AWARD & CERTIFICATION PROGRAMS 

  • Low Glycemic - Diabetic Friendly

  • Diet Friendly - Blood Sugar Claims

  • Glycemic Response - Kid Friendly

Glycemic Identity Marks (GIM)

A Symbol Of Quality, Commitment, and Integrity.

The Glycemic Identity Mark (GIM) is a symbol of quality and integrity for consumable products. It is valued by manufactures, retailers, and consumers. Having a GIM symbol on a product validates its claim and that the product has been independently evaluated and inspected by the industry's most trusted Scientific Advisory Board with over 30 years of Glycemic Index and Science Of Sweetness expertise - that products conform to the strict quality certification standards of Glycemic Research Institute.   

Glycemic Research Institute

Conducting clinical trials for over 3 decades for the largest food and beverage
companies in the world. We are the leader and revered worldwide in clinical trial evaluations for dairy and ice cream manufactures. 

Our Clinical Trial Clients Include: 

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Proctor & Gamble

State Of Florida Deprtment Of Citrus

QVC

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Glycemic Research Institute

Raising Clinical Research Standards

Diabetes Research & Clinical Trials

Diabetes & Obesity Risk Factors

Adipose Tissue Fat-Storage

Metabolic Response in Humans to foods, beverages, and sugars/sweeteners

Investigation and Trials Clinical Assessment Independent

Claim Substantiation 

ACRP - Association Of Clinical Research Professionals

Global Headquarters

Washington, D.C.

ACRPnet.ORG

 

Being part of the ACRP community means you are the gold

standard in clinical research, and you have the qualifications to prove it.

ACRP: Gold Standard Clinical Researchers

ACRP promotes excellence in clinical research

 

Raising Clinical Research Standards

 

Our members agree to adhere to a professional code of ethics defining essential ethical behaviors for clinical research professionals.

 

Founded in 1976, ACRP is a Washington, DC-based organization with more than 13,000 members who work in clinical research in more than 70 countries.

 

ACRP AFFILIATES

• Academy of Physicians in Clinical Research (APCR)

• Academy of Clinical Research Professionals

 

ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS

Dr. Ann de Wees Allen®

Chief of Biomedical Research

Glycemic Research Institute®

Board Approved Human In Vivo

Clinical Trials

ACRP MEMBER for 17 Years

From 2005 to Current

GLYCEMIC INDEX & LOAD CLINICAL TRIALS IN HUMANS

BOARD APPROVED HUMAN IN VIVO CLINICAL TRIALS: OVERVIEW AND IIRD BOARD APPROVALS

Glycemic Research Institute® (GRI) GRI CLINICAL PROTOCOLS PROVED ACCURATE IN AJCN: AMERICAN JOURNAL OF CLINICAL NUTRITION - 2008

CLINICAL TRIALS CONDUCTED: ALL GLYCEMIC CLINICAL TRIALS UTILIZED BY THE GLYCEMIC RESEARCH INSTITUTE® are: Conducted in accordance with the Food and Drug Administration regulations (FDA), and the Department of Health & Human Services.

UNDER GUIDANCE OF UNIVERSITY PHYSICIAN/M.D.

Member of the Drug Information Association and

the Association of Clinical Research Professionals

THE GLYCEMIC INDEX ACCORDING TO HARVARD MEDICAL SCHOOL: “NEUROPHYSIOLOGIC FINDINGS PROVE THAT LOW GLYCEMIC CARBOHYDRATES & SUGARS reduce overeating and facilitate maintaining healthy weight in overweight and obese individuals”

GLYCEMIC RESEARCH INSTITUTE® (GRI) GRI Human In Vivo Clinical Trials have been reviewed by the IIRB (2004/LCF-002). The IIRB Committee has conducted a Risk-Benefit Assessment on GRL’s clinical protocols and has received “Approval for Ongoing Research.”

FOOD & DRUG ADMINISTRATION (FDA)

DEPARTMENT OF HEALTH & HUMAN SERVICES

Board Approved In Human In Vivo Clinical Trials: Overview and IIRD Board Approvals

“IIRB APPROVAL: GLYCEMIC CLINICAL TRIALS APPROVED FOR ONGOING RESEARCH”

IIRB APPROVAL 

Board Approval for Trials

Investigational Review Board

INDEPENDENT

INVESTIGATIONAL REVIEW

BOARD, INC (IIRB)

The primary function of the Independent Investigational Review Board, Inc. [IIRB] is to protect the rights and welfare of human subjects involved in clinical investigations.

 

IIRB activities are conducted in accordance with the Food and Drug Administration regulations (FDA), and the Department of

Health & Human Services.

 

IIRB RESPONSIBILITIES include:

▪ Swift action for Phase I research

▪ Comprehensive centralized review of Phase II, III and IV clinical investigations

▪ Review of Device Studies

▪ DHHS/OPRR compliance for FEDERALLY-FUNDED studies

▪ Review of hospital-based studies

▪ Cooperative research review

▪ Blood/tissue (minimal risk) research review (in-service and education as needed)

 

IIRB fulfills its responsibilities through deliberate

consideration of all aspects of the research, including the assessment of the research setting, and the evaluation of the vulnerability of the research study participant.

 

The IIRB is an institutional review committee structured in compliance with both the regulations of the FDA contained in the Code of Federal Regulations (21 CFR 50 and 56) and in accordance with regulations described in 45 CFR 46 (DHHS).

 

The IIRB provides Assurance of Compliance with human subjects regulations as required by the DHHS when the research involves human subjects and is conducted by DHHS or supported in whole or in part by DHHS. In addition, the IIRB is in compliance with the regulations outlined in the

ICH/GCP guidelines.

 

IIRB was last inspected by the FDA December 2002 and was found to be in compliance with all regulations: 2022

 

In addition, the policies and procedures have been updated to be in compliance with 45CFR Parts 160 and 164, the Privacy Rule, implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

LEGAL GLYCEMIC

 

CLAIMS PER FOOD & DRUG ADMINISTRATION (FDA)

 

THE FOLLOWING REGULATORY COMPLIANCE GUIDELINES APPLY:

 

U.S. FDA REGULATORY GUIDELINES REGARDING GLYCEMIC CLAIMS

 

FOOD & DRUG ADMINISTRATION FDA REGULATORY COMPLIANCE

 

“Glycemic Statement or Claims regarding the Glycemic Status of a product is only allowed on supplements, nutrients, or products if theGlycemic Index is based on a Clinical Trial of that specific product” FDA Regulatory Compliance

 

Further, the content and formula of the sweeteners and/or carbohydrates referenced is not required to be revealed by the inventor/formulator or its manufacturer, and can remain proprietary, as the FDA has determined that “Nutrient Content is not defined for said carbohydrates, although the: Glycemic Clinical Trials are still mandatory for any claim or statement on said label. Labels must also still contain mandatory content.

 

FDA Regulatory Compliance: GUIDELINES

Glycemic Research Institute®

Glycemic.com

Board Approved Human In Vivo Clinical Trials

 

VALIDATION OF GLYCEMIC CLAIMS PER FDA GUIDELINES

 

As Chief of Biomedical Research at the GLYCEMIC RESEARCH INSTITUTE®, Dr. Allen heads the only Glycemic Research U.S.

government Certification program in the Nation, conducting 30 years of Human In Vivo Clinical Trials for the largest food companies in the world (Glycemic.com). The Glycemic Research Institute® is certified by the United States government, the Canadian government, and the United Kingdom governments to conduct Glycemic Research, Diabetic Research, Obesity

Research, and FDA Claim substantiation for foods, beverages, Nutraceuticals, and Pharmaceuticals.

 

Glycemic Research Institute®

Glycemic.com

Glycemic Research Institute

Breaking News and Research Projects
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BURGER KING RECEIVES 2008-2009 KID FRIENDLY “PRODUCT OF THE YEAR”

 

 

 

 

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