The LILACS Study: Paving the Way Forward
For decades, PCOS patients have been given the same frustrating advice—lose weight, take birth control, or try metformin if needed. But what if there was a validated, science-backed lifestyle approach that could effectively treat PCOS without medications?
That’s exactly what the LILACS Study (Lilli App Clinical Study) is designed to prove. This isn’t just another nutrition study—it’s a randomized, waitlist-controlled trial designed to evaluate the real-world impact of this lifestyle on insulin resistance and PCOS symptoms. This study takes a real-world approach by comparing it to what usually happens in clinical practice—patients being told to lose weight and come back in a few months. That’s why the waitlist control design is so important. It reflects the typical standard of care, making it a strong comparison for understanding the true impact our unique approach.
Why This Study Matters
PCOS research has long focused on weight loss as the primary goal for improving symptoms, but this study shifts the focus to insulin levels—which are the real driver of PCOS. It builds on previous research showing that lowering insulin levels can lead to weight loss and improve fertility, metabolic health, and PCOS symptoms without calorie restriction or excessive exercise.
This study is important because:
- It’s real-world applicable. Instead of comparing the Low Insulin Lifestyle to medications or extreme interventions, it compares it to the reality that many PCOS patients face—being told to “just lose weight” with no clear guidance.
- It strengthens the case for insulin testing. PCOS patients are rarely tested for insulin resistance, despite overwhelming evidence that it plays a major role in their symptoms. If this study shows significant improvements, it could further push for routine insulin testing.
- It helps validate prior research. Previous studies, including a randomized controlled trial, a retrospective case series, and metabolic studies, have all pointed to the benefits of lowering insulin. This study is another step in replicating and expanding that research.
Study Design
- Participants: Patients diagnosed with PCOS and insulin resistance
- Groups:
- Intervention Group: Immediately start the Low Insulin Lifestyle
- Waitlist Control Group: Continue with standard care for the first part of the study, then start the intervention
- Duration: 8 weeks of lifestyle intervention
Because this is a waitlist-controlled study, both groups will eventually receive the intervention. This makes it ethically sound while still allowing for a meaningful comparison between the intervention and typical care.
What This Study Will Measure
The LILACS Study will track multiple key health markers to evaluate the effectiveness of the Low Insulin Lifestyle. Some of the main outcomes include:
- Weight loss and body composition improvements
- Changes in insulin resistance (measured by fasting insulin, C-peptide, and other metabolic markers)
- Menstrual regularity and ovulation restoration
- Improvements in PCOS symptoms like acne, hirsutism, and energy levels
- Patient-reported quality of life
By gathering this data, we can quantify how well this approach works and set a new standard for PCOS treatment.
The Potential for FDA Clearance
This study is not just about proving that the Low Insulin Lifestyle works—it’s about getting it recognized at the highest level.
If the study shows significant benefits, the Lilli Health app could become the first FDA-cleared digital therapeutic for PCOS. This means:
- Doctors could formally refer patients as a validated treatment for PCOS
- Women could access science-backed support without needing medication
- The Lilli Health app could be covered by insurance, making it even more accessible
This would be a game-changer for PCOS care. Instead of outdated advice that puts all the burden on the patient, PCOS treatment could finally be backed by real clinical data and FDA clearance.
Why This Matters for You
If you have PCOS, you deserve more than just “eat less and exercise more.” The LILACS Study is about proving that a targeted, insulin-focused lifestyle is the most effective way to reverse PCOS at the source.
By prioritizing insulin management, we’re not just managing symptoms—we’re giving women the tools to take control of their health, improve fertility, regulate hormones, and feel better than ever.
