Understanding the Gold Standard in Clinical Trials for Dietary Supplements

As the CEO and co-founder of Citruslabs, I often reflect on the rigorous standards applied to clinical trials for supplements. Traditionally, many professionals and consumers view randomized controlled trials (RCTs), particularly double-blind, randomized control trials, as the pinnacle of scientific research. This methodology is the gold standard in the pharmaceutical industry, but when it comes to dietary supplements, which are not permitted to make treat, cure, or prevent disease claims like drugs, I ask myself: should clinical trials for supplements be held to the same stringent standards?

RCTs: The Traditional Benchmark

RCTs are highly regarded for their ability to minimize bias, providing a clear distinction between the effects of a supplement and a placebo. This format is crucial in the drug approval process, where the potential risks of a new drug are rigorously assessed against its benefits. However, dietary supplements, which support general health rather than addressing specific medical conditions, require a different set of considerations. And here is a provocative thought:

Supplements often thrive on the placebo effect.

Sometimes, this is all that is needed because the primary goal of supplements is not to treat or cure diseases but to help healthy individuals feel better. In this context, whether the benefits stem from an active component of the supplement or from the placebo effect may be less critical. What matters most is the subjective improvement in wellbeing experienced by the user, underscoring a distinct approach to evaluating the efficacy of supplements compared to pharmaceuticals.

The Need for Tailored Standards

While the design of a study is crucial, the methodologies employed to gather data are equally important. The Federal Trade Commission (FTC) has defined what constitutes a reliable scientific study primarily by its design rather than the methods used to measure outcomes. However, in my view, incorporating objective biomarkers like bloodwork or microbiome testing should also be integral to the gold standard for clinical trials for supplements.

Going Beyond Questionnaires: The Role of Biomarkers

From my perspective, a trial that utilizes objective markers such as blood, stool, or skin collection can provide a more definitive understanding of a supplement's impact than a questionnaire-based RCT. These biomarkers offer quantifiable data that can objectively measure the physiological effects of the supplement, providing a clearer picture of its efficacy.

Emphasizing Methodology in Supplement Trials

It's intriguing that while the study design is strictly defined, less emphasis is placed on the methodologies that I consider crucial for establishing a gold standard in clinical trials for supplements. Objective measurements like those obtained from blood tests or microbiome analyses offer concrete, verifiable results that can enhance the credibility and relevance of the findings. These methods can detect subtle changes and improvements in health markers directly influenced by dietary supplements.

For dietary supplements, redefining the gold standard of clinical trials for supplements to include rigorous methodologies alongside traditional RCT designs could lead to more precise and meaningful insights into how these products can benefit health. But, it could also lead to disappointment because the placebo effect is real. As the industry evolves, it may be time to consider these broader criteria, which encompass both innovative study designs and advanced scientific techniques, to truly gauge the effectiveness of supplements. This approach not only aligns with scientific rigor but also adapts to the unique nature of dietary supplements, ensuring that consumers receive reliable and actionable health information.

Lucky you that Citruslabs doesn't follow a one-size-fits-all approach but customizes each study to its client's goals, needs, and budgets. Ready to move forward? Contact us here.