Glycemic Research
Institute®
Third-party Certification- Independent Validation of Regulatory and National Standards
Glycemic Research Institute®
Capitol Hill
300 New Jersey Ave. Northwest Suite 900
Washington, D.C., 20001
GRI Sectors & Research Specialties
The Glycemic Research Institute® (GRI) is one of the leading global authorities in research and development in the fields of Glycemic Index and the metabolic impact of foods and beverages in humans.
Glycemic Research Institute®
Clinical Trial Clients
For over 35 years, we are proud to have worked with some of the most prominent companies in the food and beverage industry. Our research, development and clinical trials have made us a trusted partner worldwide.
Glycemic Research Institute® has conducted IRB Board Approved Human In Vivo Clinical Trials for the following companies for claim substantiation and labeling claims:
Proctor & Gamble
State of Florida Dept. of Citrus
QVC
Glycemic Research Institute®
U.S. Regulatory Guidelines
Why is third-party certification important?
Third-party certification is validation and proof that the “product” has met the standards as set forth by the certifier and said product is in compliance with the applicable code and law.
Third Party Certification demonstrates independent validation of regulatory and national standards as set forth by the said government regulations, such as the U.S. FDA (product labeling-CFR 21 Guidelines), U.S. FTC (claims), and/or NSF Approval and Certification), ISO Certification for quality management or organic certification for food products.
National Science Foundation (NSF) Certification
One of the most important and significant certification organizations in the world is NSF.
NSF International's Certified for Sport® program tests and certifies nutritional supplements used by athletes in Major League Baseball (MLB), the National Football League (NFL), the Professional Golf Association (PGA), the Ladies Professional Golf Association (LPGA) and the Canadian Centre for Ethics in Sport (CCES).
U.S. Anti-Doping Agency & NSF
Certified for SPORT®
The USADA currently recognized the NSF Certified for SPORT® as the program best suited for athletes to reduce the risk from supplements. For more information, see USADA Athlete Advisory and NSF FAQ.
FDA Regulatory The Food and Drug Administration
The FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.
The Glycemic Research Institute® & Legal Certification Marks
The Glycemic Research Institute® Certifications, Human In Vivo Clinical Trials, and Sports Certifications comply with FDA Regulatory guidelines and has submitted their R & D Sports Drinks to NSF for Independent Certifications for NSF CERTIFIED FOR SPORT, which were awarded the NSF for Sport Certification.
LEGAL Certification Marks: The Glycemic Research Institute® Certifications are registered in the category of “Product-Specific” as duly recognized by the U.S. Government (USPTO.gov). The Glycemic Research Institute® registered Certification Mark has been extended from 2020 to 2033 by the U.S. Government.
Glycemic Research Institute
IIRB Board Approved Human in Vivo Clinical Trials
Diabetes Research & Clinical Trials
Diabetes & Obesity Risk Factors
Adipose Tissue Fat-Storage
Metabolic Response in Humans to foods, beverages, and sugars/sweeteners
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.”
Investigation and Trials Clinical Assessment Independent
Claim Substantiation
FOOD & DRUG ADMINISTRATION (FDA)
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 19 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”
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)
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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:
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â–ª Swift action for Phase I research
â–ª Comprehensive centralized review of Phase II, III and IV clinical investigations
â–ª Review of Device Studies
â–ª DHHS/OPRR compliance for FEDERALLY-FUNDED studies
â–ª Review of hospital-based studies
â–ª Cooperative research review
â–ª 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 the Glycemic 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
Board Approved Human In Vivo Clinical Trials
VALIDATION OF GLYCEMIC CLAIMS PER FDA GUIDELINES
The Glycemic Research Institute®, represents 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, to conduct Glycemic Research, Diabetic Research, Obesity Research, and FDA Claim substantiation for foods, beverages, Nutraceuticals, and Pharmaceuticals.
" In GOD we trust; all others must show data."
BURGER KING RECEIVES 2008-2009 KID FRIENDLY “PRODUCT OF THE YEAR”
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