Clinical trials for
dietary supplements

There are many different study designs available for dietary supplement clinical trials. Typically, brands start with pilot studies, which are single group (one study arm) and don’t involve a placebo or a control group. Larger brands that already did in-house research also opt for a randomized-controlled trial (RCT) as their pilot study. Studies like these involve at least two study groups (one intervention group and one control or placebo group). The gold standard is a double-blinded randomized-controlled clinical trial, which involves three or more arms (intervention, placebo, and control arm) and neither the study participant, nor the study team knows which participant received the placebo and who received the actual supplement. Another possibility is a crossover study, which belongs to the RCT family, but only includes one study group that serve as their own control group. A crossover study gives you the advantages of an RCT, while staying on a budget. Lastly, consumer perception studies are also an option to consider for supplement brands. These students are less scientific than clinical trials, but still a good way to create robust product claims.

Generally, vitamins can be found on the FDA GRAS list, which lists substances and chemicals that are Generally Recognized As Safe (GRAS). Chemicals and substances on this list are considered safe by experts under the conditions of their intended use and typically underwent clinical studies that were looking at primarily safety. Vitamins or multivitamins sold as dietary supplements can typically be found on that list. However, dietary supplements don’t have to go through clinical trials before reaching shelves and being sold to consumers. However, some brands choose to go the extra mile and pursue clinical trials when launching new products. Brands use these studies to create science-backed product claims that drive trust as well as business growth.

No, dietary supplements do not require FDA approval before being sold. However, brands are responsible for ensuring product safety and truthful labeling. The FDA can take action if a supplement is found to be unsafe or makes misleading claims. Supplements cannot claim to treat, cure, or prevent diseases without FDA approval.

The duration of a supplement clinical trial depends on the type of outcome being measured. Most trials run for 6 to 12 weeks, especially if the goal is to measure effects like improved sleep, digestion, energy, or skin health. However, longer trials may be needed for outcomes like weight loss or hormonal balance.

Beyond the trial itself, the full process: including study design, ethical review (IRB), participant recruitment, data collection, analysis, and reporting, typically takes 3 to 6 months from start to finish. Planning ahead ensures that your study aligns with product launch timelines or marketing campaigns.

Not necessarily. Placebo-controlled studies offer stronger evidence by showing your supplement’s effects beyond the placebo response, making them ideal for robust claims. However, single-arm trials (with no placebo group) can still deliver meaningful insights, especially for early-stage validation or when working with limited budgets or faster timelines.