01 · What is established
The signal that has earned confidence.
- People vary in postprandial responses, preferences, behaviors, and metabolic risk.
- Wearables and at-home testing can create dense longitudinal data outside traditional clinical settings.
- The current U.S. framework was not designed for services that combine foods, devices, algorithms, and health recommendations.
02 · What remains unsettled
The uncertainty is part of the answer.
- Which response phenotypes reproduce across time and meaningfully improve decisions.
- How algorithms should be validated when both the model and the user behavior change.
- Where wellness guidance ends and regulated medical or diagnostic functionality begins.
03 · What this changes
From scientific landscape to decision architecture.
Berkwood evaluates the full evidence chain behind personalized systems, identifies the validation burden for the intended claim, and helps teams create frameworks that protect users while enabling responsible innovation.
Selected work
Read into the evidence.
Perspective · 2025
Challenges for Personalized Nutrition in the Current United States Regulatory Framework and Future Opportunities (PubMed, opens in new tab)
Donovan SM, Abrahams M, Anthony JC, Bergia R, et al.. Advances in Nutrition 16(3):100382.Randomized controlled trial · 2023
Differential Responders to a Mixed-Meal Tolerance Test Associated with Type 2 Diabetes Risk Factors and Gut Microbiota: MEDGI-Carb (PubMed, opens in new tab)
Skantze V, Hjorth T, Wallman M, … Bergia RE, et al.. Nutrients 15(20):4369.Randomized controlled trial · 2022