Take it from them; read articles written by experts that run the gamut from product development, to quality assurance and regulatory, to contract manufacturing.
You may have heard the word “efficacy” and wondered exactly what that means as it relates to dietary supplements – beyond, of course, its literal definition which means producing a desired or intended result.
In dietary supplement terminology, showing an ingredient’s efficacy is not simply having a group of people take the product and testing the results. Various types or families of ingredients require specific tests to identify their unique structures that may serve as the active component, which will then be tested to see how it impacts specific structures or functions in the human body.
The key lesson here is that you cannot just go straight to formulation and plan on conducting clinical trials to determine effect. At minimum, the ingredient must meet the FTC demands of support by “good science,” which is not a single, clear standard.
To show the efficacy of an ingredient, the supplier must be willing to invest in necessary research and development of genetic analysis, in vitro testing and human clinical studies. There are some who believe that a single human clinical study is enough, but many suppliers perform multiple clinicals, either to establish new claims or for further validation of previous studies, or to determine how effective the ingredient may be for the same claim but in different population groups (eg, overweight middle-aged women versus overweight middle-aged men).
At Deerland, we first determine the structure of the ingredient. For enzymes, we analyze the amino acid structure. Probiotics necessitate genome sequencing, a laboratory process that determines the DNA sequence of an organism. This sequence reveals the activity of the various genes comprising the genome, how those genes interact, and how the various parts of the genome are coordinated. This is an essential first step in determining safety of the ingredient. For example, Deerland’s DE111® strain of Bacillus subtilis was genetically sequenced in partnership with Cornell University, and was found to contain no plasmids, deleterious genes or antibiotic resistant genes. Sequencing also reveals genes that may offer certain benefits. For example, the sequencing of DE111 showed that the strain contains genes that increase IgG and IgA (antibodies), which support immune health.
Next, we perform in vitro testing to determine how an enzyme or probiotic will function under physiological conditions. Depending on the enzyme or probiotic strain, this will include a variety of testing methods. For example, our ProHydrolase® was tested using gel electrophoresis to determine how quickly and efficiently the product could break down whey protein for fuller absorption of amino acids. The same method was used to determine Glutalytic’s effect on gluten digestion.
Based on the successful results of in vitro testing, we move on to human clinical studies. Our clinical studies are submitted to and approved by an Institutional Review Board (IRB) before they begin. A quality (reliable) study design is one that is double-blind and placebo controlled. (We have conducted human clinical studies on our branded products ProHydrolase®, DE111®, Glutalytic® and PreforPro®.) When the study is complete and the data has been analyzed, the study abstracts are submitted to applicable peer-reviewed journals for publication. Published studies allow the public to access the clinical results of the ingredient (and sometimes, a finished product/formula).
For a reputable, quality supplier, the efficacy investment doesn’t end. There are always more studies to perform and research to do.
An educational enzyme and probiotic resource
Digestible is your go-to resource for learning about enzymes, probiotics and their impact on digestive health. Keep up with the latest trends in dietary supplements, learn why gut health is critical to overall wellness and immunity, and the science behind it all.
Dr. John Deaton is vice president of technology at Deerland Probiotics & Enzymes, with more than 18 years experience working with proteins and enzymes. He holds a PhD in biochemistry from Texas A&M University, with post-graduate studies in microbiology, biophysics and cancer research. He has two papers published in the Proceedings of the National Academy of Sciences (PNAS) and is a six-year member of the Association of Official Analytical Chemists (AOAC), with three years served on the committee of microbiology.