Clinical trials are a crucial part of verifying the safety and effectiveness of functional foods (FFs). However, many people misunderstand this process, leading to common misconceptions. In this article, the Academy of Medical Sciences explains five widespread misconceptions about clinical trials of functional foods to help you gain a clearer perspective.

1. "Functional foods don’t need clinical trials, production alone is sufficient"

Common misconceptionMany believe that FFs are merely health-supporting foods, not drugs, so they don’t need rigorous trials. They assume that once a product is manufactured, it is automatically deemed safe.

The truthWhile FFs are not classified as drugs, they still require clinical trials to ensure their safety and effectiveness. This is critical because FFs directly affect consumers' health, from providing nutritional support and improving body functions to reducing disease risks.

Clinical trials evaluate:

• Optimal dosage.
• Suitable target users.
• Potential side effects.

Without clinical trials, consumers risk using ineffective or even harmful products. Therefore, these trials are essential for transparency and product credibility.

2. "Clinical trials are just marketing gimmicks by companies"

Common misconceptionSome people are skeptical, believing that clinical trials are merely for commercialization, intended to attract customers without genuinely ensuring product quality.

The truthClinical trials are scientific processes conducted under strict standards set by regulatory health authorities, such as the U.S. Food and Drug Administration (FDA) or equivalent agencies.

The basic steps in clinical trials include:

1. Preclinical stage: Research on animal models or cells.
2. Clinical trial phases: Divided into three phases focusing on evaluating safety, effectiveness, and human tolerance.

Data collected during these trials undergo thorough analysis and are often reviewed independently before publication. Companies engaging in fraud face severe legal consequences and lose consumer trust.

3. "Testing on a small group is enough to represent the population"

Common misconceptionSome believe that testing FFs on a small group of participants is sufficient to assess the product's safety and effectiveness.

The truthThe scale of a clinical trial is crucial for ensuring objectivity and reliability of the results. A small sample group cannot fully reflect the diversity in physiology, age, gender, or health conditions of the consumer population.

Reliable trials usually require:

• Large sample sizes: Hundreds to thousands of participants, depending on the research goal.
• Diverse representation: Ensuring inclusion of different demographic groups.
• Double-blind, placebo-controlled design: Minimizing bias from both participants and researchers.

Testing on a small group could lead to inaccurate conclusions, potentially endangering consumers when the product is released.

4. "Clinical trial results are always 100% accurate"

Common misconceptionSome people have absolute faith that clinical trials always provide precise results with no margin for error.

The truthAlthough clinical trials are designed to uphold scientific rigor, they are not infallible. Several factors can affect outcomes:

• Design flaws: Poorly designed trials can lead to skewed results.
• Insufficient sample size: May not represent all consumer groups.
• Environmental and individual differences: People react differently to the same product.

Therefore, results from one clinical trial often need validation through multiple independent studies before a final conclusion is drawn.

5. "Clinical trials carry no risks and only bring benefits"

Common misconceptionMany assume that clinical trials solely benefit both manufacturers and participants, posing no risks at all.

The truthClinical trials, especially in early stages, can entail risks:

• Adverse reactions: Some participants may experience unforeseen side effects.
• Unanticipated risks: Rare but serious complications can arise.

For this reason, organizations conducting trials must adhere to strict ethical guidelines, including:

• Full disclosure: Participants must be informed clearly about the purpose, process, and potential risks.
• Informed consent: Trials are conducted only on voluntary participants.
• Close monitoring: Medical teams supervise the process to intervene promptly in case of issues.

Conclusion

Clinical trials are not only mandatory but also foundational in ensuring the safety and effectiveness of functional foods. The Academy of Medical Sciences hopes this article helps clarify common misconceptions about these trials.

As consumers, always choose products that have undergone thorough testing and are certified by reputable health organizations. Stay informed to make smart and safe decisions for your health.