Weight Loss and Maintenance – Putting Weight into Weight Loss Claims
With rising global obesity rates and growing consumer interest in effective weight management solutions, the demand for scientifically substantiated weight loss products has never been greater. This white paper critically examines the complexity of weight loss, highlighting the limitations of popular claims and the need for rigorous clinical evidence. It explores the roles of genetics, gut microbiota, hormones, and molecular biology in body weight regulation and introduces the concept of a Global Index as a more holistic and relevant endpoint for weight loss studies. Featuring insights into regulatory scrutiny, market trends, and innovative clinical trial designs like the Augmented RCT and N-of-1 trials, this is a must-read for companies aiming to develop credible and compliant weight management products.
More Than a Gut Feeling – Using Probiotics to Build a Better Microbiome
Probiotics hold immense potential in optimizing gut health and redefining human wellness. This white paper explores the science behind the human microbiome, the evolving global probiotics market, and the regulatory complexities shaping claims in the U.S., Canada, and Europe. It highlights the critical role of well-designed clinical trials in substantiating probiotic benefits, especially given microbiome variability across populations. With insights on study design, site selection, CRO partnerships, and Canada’s regulatory advantages, this paper is an essential guide for companies seeking to bring effective, evidence-backed probiotic products to market.
Legal Marijuana – A Canadian Case Study in Cannabis Regulation and Market Opportunity
With Canada becoming the first G7 nation to legalize recreational cannabis, this white paper from KGK Science examines the country’s pioneering regulatory journey and its ripple effects on research, commerce, and consumer health. Backed by original survey data and regulatory analysis, the paper explores usage patterns, legislative milestones, clinical research opportunities, and lessons learned from global cannabis policies.
Ideal for policymakers, researchers, and companies entering the cannabis space, this report provides a comprehensive look at how legalization is reshaping health innovation and opening new frontiers in functional cannabis product development.
The KGK Augmented RCT© – Moving the Gold Standard to the Supplement Industry
The randomized controlled trial (RCT) has long been considered the gold standard in clinical research—but is it always the best fit for the complex, multi-targeted nature of dietary supplements? This thought-provoking white paper from KGK Science explores the limitations of traditional RCTs in the context of nutrition science and proposes an innovative solution: the KGK Augmented RCT©.
By integrating methodologies such as N-of-1 trials, open-label phases, global health indices, and broader inclusion criteria, the Augmented RCT© offers a more flexible and holistic framework tailored for the supplement industry. Learn how this adaptive design can enhance claim substantiation, reduce trial failure, and align more closely with real-world consumer outcomes—while maintaining scientific rigor and regulatory compliance.
Ideal for sponsors, product developers, and regulatory strategists, this white paper redefines how evidence can be generated for functional foods and nutraceuticals in a personalized health landscape.
Probiotics & Infant Nutrition – Little Babies, Big Claims
As interest in probiotics surges, their inclusion in infant nutrition products has created both opportunity and controversy. This white paper explores the evolving regulatory landscape and growing scientific evidence surrounding probiotics in infant formulas and supplements. Authored by experts at KGK Science, it highlights the critical importance of well-designed clinical trials, strain-specific substantiation, and ethical marketing practices when targeting the most vulnerable population—infants.
With a focus on global regulations, safety considerations, and research gaps, this paper provides essential insights for manufacturers seeking to develop credible, effective, and compliant probiotic products for infants.
Avoiding a Regulatory Nightmare – Designing Clinical Trials for Dietary Supplements
Clinical trials offer a powerful way to differentiate your dietary supplement—but only if designed with regulatory compliance in mind. This white paper outlines critical strategies for designing trials that align with FDA and FTC guidelines while generating credible, claim-supporting evidence. Learn how to choose the right endpoints, define your target population, and avoid the common pitfalls that can lead to costly enforcement actions. A must-read for companies looking to substantiate structure/function claims and stand out in a crowded market—without inviting regulatory scrutiny.
Use of Patient Reported Outcomes for Substantiation of Structure Function Claims
As the use of consumer surveys and subjective questionnaires grows in the clinical trial space, Patient Reported Outcomes (PROs) are gaining attention as tools for substantiating structure/function claims on food and dietary supplement products. This white paper, authored by Dr. Corey Hilmas and Andrew Charrette of KGK Science, explores how PRO instruments—particularly PROMIS® tools—can be used effectively, their regulatory limitations, and how to balance subjective and objective endpoints for compliant and credible claims.
A must-read for sponsors and product developers looking to leverage PROs in their clinical research strategy.
Letter to the Industry: Clarifying FTC’s Stance on Structure-Function Claim Substantiation
In the wake of recent trade press confusion, KGK Science sets the record straight on FTC’s Health Products Compliance Guidance. This letter critically analyzes misleading interpretations around substantiation standards, including the use of randomized controlled trials (RCTs), the definition of structure-function claims, and the difference between FTC and FDA expectations. With clear insights and regulatory expertise, KGK provides reassurance that while terminology may shift, the evidentiary standard remains the same: competent and reliable scientific evidence.
Regulatory Considerations for Conducting Foreign Clinical Trials
As global interest in clinical research expands, navigating the regulatory landscape for foreign clinical trials is increasingly complex. This white paper provides insights into the key requirements, ethical standards, and submission strategies essential for conducting compliant and effective studies outside the sponsor’s home country. Whether you’re considering trials in Canada, the U.S., or overseas, this guide helps you plan with confidence and avoid costly missteps.
Beyond Exhaustion
We created this eBook to bridge the gap between scientific research and practical solutions, providing individuals affected by cancer with a comprehensive understanding of fatigue and evidence-based strategies to manage it. Our extensive research explores the biological mechanisms behind CRF, conventional and alternative treatment options, and the role of nutrition, exercise, and mind-body therapies in […]