Brain Health Clinical Trials: 5 Mistakes to Avoid



Mon, Oct 24, 2022 12:00 PM EDT Brain Health is on everyone’s mind! Beat the competition by avoiding these 5 mistakes when designing a study for your next ingredient!

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Event Overview:

Brain health is a complex end goal that is defined by attention, mood, anxiety, stress and age-related cognitive decline. The functional ingredient space already has innovative brands approaching the problem with diverse approaches, including the gut-brain axis, whilst generating unique health claims.
How do you differentiate your ingredient? Support with clinical trials for marketing clout is critical but
designing a clinical trial for cognition can be tricky; the population may vary, the tools used are vast and the time taken to show effect may be difficult to estimate.
A well designed and executed clinical trial demands:

  • Extensive planning
  • Awareness of the regulatory constraints
  • Generation of meaningful and supported marketing claims
  • A keen awareness of the needs of product formulators and consumers.

How will you select the most competitive health claim for your product and how will you substantiate this using a clinical study?
From the start one must consider the end-use, including how you are going to market the study, conveying results to B2B customers and consumers.

  • Define the advantages of supporting your product or ingredient with clinical trials
  • Upon completion, what next? How to get it published in a peer reviewed journal?
  • Marketing the study: what are your options and approach?

Before you proceed with the next brain health study, here are 5 mistakes you can avoid and convert them into your USPs while designing and executing the trial!

Key Learning Objectives:

  • To better understand how to design clinical trials to enhance your branding efforts
  • What is hot in cognitive health and what kind of health claims are made globally
  • Define a strategy for next steps after completing a successful clinical trial
  • Understanding how scientific validation is a strategic business development activity
  • Process of an ideal clinical trial and the 4 step design of any clinical trial (Preparation, Documentation, Operations, Statistical Reporting)

Who Should Attend:

  • Suppliers focusing on making health claims like attention, mood, gut health, with respect to cognitive health support, cognitive impairment and cognitive decline
  • C-suite executives and board members of branded ingredient companies that have sponsored,
  • or are contemplating the sponsorship of, clinical trials
  • Product developers that need validated marketing claims for reduced regulatory risk and marketing optimization
  • Ingredient companies that need to establish a competitive advantage
  • Healthcare providers that need to understand the clinical trial process and how it affects them


Mark JS Miller
President at Kaiviti Consulting LLC

Dr. Mark Miller has made significant contributions as both researcher, entrepreneur and marketer in the fields of health & medicine. During his three decades as an elite biomedical researcher & Medical School Professor he made major discoveries that has changed how we approach health & disease. Dr. Miller has been instrumental in advising Vedic Lifesciences and several functional ingredient and finished good companies in matters such as study design, new product formulation and concept development.
Just as he has done in academic medicine, Dr. Miller has led a path of transformative disruption in the business world. Dr. Miller has been a successful entrepreneur, product developer, marketer, key opinion & business development leader, and C-Suite executive to the Private Equity Community
Dr. Miller is a self-described historical futurist, a possibility aficionado, an unrepentant coddiwompler, avid smirker & story-teller. Currently, Dr. Miller is a Consultant with Kaiviti Consulting, serving the global nutrition & wellness industry.

Jayesh Chaudhary
CEO, Founder
Vedic Lifesciences

Jayesh Chaudhary has been one of the interesting contributors to the health and nutraceutical industry for 20+ years – he is the Founder of Enovate Biolife that develops ingredients, one of which won the Nutraingredient Award for USA and Asia in 2019, as well as Vedic Lifesciences, that engages in Preclinical and Clinical trials of health ingredients and branded dietary supplements. Every claim is a lie until you prove it, is his theory. Health claim substantiation is extremely essential for supplementing good body function with a healthy diet so as to govern the disorder-associated / Lifestyle-associated symptoms. He has leveraged this very component, combining it with India’s low-price factor, India’s supplement-naïve population, in crafting the company to deliver top-notch clinical study operations with globally-accepted quality standards of ICH-GCP.
Jayesh has been pivotal in taking the Indian Clinical Contract Research Organization segment on a global platform – breaking the ceiling of quality and IP management misconceptions in India. He has collaborated with several regulatory associations and leading ingredient companies in North America, Europe and APAC region for consultations, clinical trials and knowledge transfer. You can usually find him fermenting beetroots and living an extremely ‘Vedic’ life.

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