What Is Clinical Trial?
A research study conducted with human participants to evaluate the safety, efficacy, or optimal dosage of a treatment, intervention, or supplement ingredient under controlled conditions.
Why It Matters for Supplement Brands
Clinical trials provide the strongest category of evidence for supplement claim substantiation. FDA and FTC both recognise well-designed clinical trials as the gold standard for supporting health-related claims. The number and quality of clinical trials available for an ingredient directly impacts the strength of your substantiation file.
How It Works
Clinical trials for supplements typically follow these phases:
1. **Phase I (Safety)**: Small group (10-50 people), primarily assessing safety and dosage 2. **Phase II (Efficacy)**: Larger group (50-300), evaluating whether the ingredient produces the claimed effect 3. **Phase III (Confirmation)**: Large-scale (300-3,000+), confirming efficacy and monitoring side effects
Key design elements that strengthen a trial's evidence value: - **Randomisation**: Participants randomly assigned to treatment or control - **Double-blinding**: Neither participants nor researchers know who receives the active ingredient - **Placebo-controlled**: Control group receives an inactive substance - **Adequate sample size**: Large enough to detect meaningful differences statistically
Common Mistakes to Avoid
- ✗Citing pilot studies (small, preliminary trials) as definitive evidence of efficacy
- ✗Not distinguishing between Phase I safety studies and Phase II/III efficacy studies
- ✗Relying on open-label (unblinded) trials where placebo effect can't be ruled out
Related Terms
See It in Action
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