Glycemic Research Institute
METABOLIC IMPACT OF FOODS & BEVERAGES IN HUMANS
International Government Accredited Certification Organization
Board Certified Human In-Vivo Clinical Trials
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)
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Foods
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Meals
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Prepared Foods Nutraceuticals
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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:
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
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Low Glycemic - Diabetic Friendly
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Diet Friendly - Blood Sugar Claims
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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:
Proctor & Gamble
State Of Florida Deprtment Of Citrus
QVC
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
BURGER KING RECEIVES 2008-2009 KID FRIENDLY “PRODUCT OF THE YEAR”
