Clinical trials are typically designed by drug and medical device manufacturing companies to explore specific product features impacting human health. While they tend to be organized by the companies, many government organizations regulate clinical trials and claims about trial findings globally, including the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC).
While food and beverage consumption often play just as large of a role in regulating human health as drugs and medical devices, food clinical trials are lacking. Clinical trials are the primary way that researchers find out if a new drug or medical device is safe and effective in humans, so why don’t food and beverage products that make specific health claims go through the same process?
Here’s what you need to know about the burgeoning food clinical trial space, including what they are and what purpose they serve.
What are Food Clinical Trials?
Food clinical trials are often designed to evaluate specific marketing claims needing scientific substantiation. They tend to be more pragmatic and exploratory since they document human experiences with specific foods in the context of the human diet. They are generally conducted to evaluate the effect of food and beverage products on the prevention or mitigation of symptoms, rather than the treatment or cure of a condition.
Food trials typically enroll healthy individuals as opposed to patients with a specific disease type potentially needing the research treatment. The food and beverage products involved in trials are complex mixtures of ingredients designed to be appetizing and which may have the general health effect under investigation. They often use measures involving the senses including food taste, texture, and feelings of satiety and bloating.
Like drug and medical device clinical trials, food clinical trials should be conducted using the FDA’s Good Clinical Practices (GCP) with appropriate Human Subject Protections (HSPs). All food and beverage products used in human testing should also be produced under Good Manufacturing Practices (GMP). Food clinical trials must also clearly define the study objectives, inclusion and exclusion criteria, study measurements and statistical analyses.
Unlike drug and medical device clinical trials, food clinical trials do not typically require a safety review by the FDA before the trial can commence. Additionally, they generally have only one phase, take several weeks to months to complete, are conducted at a single study site and have minimal risk of adverse events.
What Purpose do They Serve?
The demand for food and beverage products with proven health effects (functional foods), such as improved intestinal or muscle health, is increasing. Food clinical trials exist in order to provide insight on a food or beverage product’s impact on human health, add to the evidence of a health benefit and/or provide measurable outcomes that meet regulatory requirements.
Companies hoping to market a food health claim on a product’s label must provide supporting data from high-quality, non-biased human clinical studies. Food clinical trials can help substantiate a variety of claims, including:
- Function claims
- Contributes to regular bowel movements
- Promotes gut health
- Nutrient claims
- Reduces spikes in blood sugar
- Therapeutic claims
- Probiotic/prebiotic claims
Effective trials often start with the desired claim in mind and are built around the claim as the rationale for the study. It is crucial to ensure the claim is relevant for human health and the meaning of the claim has been fully supported by the food clinical trial data. They must also ensure that the quantity of food consumption is possible as part of a balanced diet in the target population for the claim.
Most importantly, linking the claimed effect to the consumption of the food or beverage products is essential in food clinical trials. However, clearly defining effects and outcomes can present some challenges, especially when defining subjective measures like cognition, pain or hunger as opposed to objective measures like hemoglobin levels or weight.
While there are many factors and variables to consider, when done properly, food clinical trials can produce valuable outcomes for food and beverage companies. Being able to scientifically substantiate health claims can increase trust among consumers as well as market value.