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. 2025 Jul 29;14(15):2675. doi: 10.3390/foods14152675

Table 1.

Differences between pharmaceutical and functional food clinical trials.

Feature Pharmaceutical Trials Functional Food Trials References
Primary goal Efficacy and safety Health promotion and prevention [16]
Study design complexity High (controlled, standardized) High (dietary habits vary) [15]
Regulatory oversight Strict (FDA, EMA) Emerging, diverse globally [17]
Confounding variables Minimally present Highly present (diet, lifestyle) [17]