In anticipation of his presentation as part of the Preventative Health and Immunity session at Vitafoods Europe in May, Biothera’s Don Cox, Ph.D., senior vice president, Healthcare Group R&D, Biothera, offers 10 tips for evaluating immune health ingredients. For more information on the program visit http://www.vitafoods.eu.com/conference.
Dietary interventions to support immune health are bringing new excitement to the food and beverage industry. Here are 10 factors to consider when evaluating immune health ingredients:
- Ingredient safety: Ensure that the ingredient has safety data published in a peer-reviewed toxicology journal and reviewed by EFSA (EU), the US FDA and/or other leading regulatory agencies. Request and review the government’s regulatory letters.
- Mechanism of action: Studies should be conducted in a manner that demonstrates the mechanism of action as measured by its effect on the innate or acquired immune system. Independent, peer-reviewed, published research is best.
- Method of boosting: Some immune boosters provide temporary stimulation and create an artificial and unnatural state that may damage the body if taken too long. Others safely boost the body’s natural immune mechanisms to respond to a challenge, maintain immune system balance and can be taken year-round.
- Quality and quantity of the clinical research: Look for multiple peer-reviewed, published, high quality studies with consistent outcomes. Peer-reviewed, double-blinded, placebo-controlled clinical studies are the gold standard.
- Research source: Examine whether the research was conducted with the specific ingredient or borrowed from other products. Borrowed science is junk science. The specific biological strain or chemical structure matters.
- Study design: Design is important to eliminate unintentional bias. Understand and weigh the merits of single blind, open label, double blind, and crossover study designs. While all are valid designs, double-blind studies and crossover design eliminate data variations owing to the physical make up of each treatment group.
- Outcomes employed: The major forms of outcomes of scientific and regulatory interest are biomarker outcomes and physical health outcomes. Many outcomes can be misinterpreted or are surrogates for the clinical endpoint. Outcomes in human clinical studies must have a demonstrable positive benefit for humans. Outcome selection is not always clear cut.
- Ingredient characterization: The health benefit activity must be attributed to known component(s) with well defined molecular structure. Characterization allows for measurement and standardization required for establishing serving recommendations, consistency in manufacturing and stability and shelf-life testing. Identifying the active component is necessary for determining the desired health effect; it also provides confidence that the efficacy or stability is the same from batch to batch.
- Serving size determination: Ensure that the ingredient’s dose-response data supports the recommended daily serving. A demonstration of dose response is the best indicator of optimum or effective serving.
- Formulation characteristics: No matter how safe or effective the ingredient, it is essential that it can be formulated into foods and beverages so that the ingredient doesn’t break down and lose its potency if exposed to heat, pH or pressure required in the manufacturing process. It is critical that appropriate analytical methods be available to quantify the amount of the ingredient present in the food or beverage after processing and at the end of the projected shelf life of the product.