Validating a Phytomelatonin Formula for Sleep & Emotional Well-Being
Discover how Reputable's research platform empowered a leading nutraceutical brand to scientifically substantiate their product's benefits for sleep and mood.
Participants fell asleep significantly faster (p=0.005), a clinically relevant outcome for sleep initiation.
A major reduction in time awake at night, indicating more restorative sleep (p=0.035).
A significant improvement in participant-reported emotional health and mood (p=0.034).
Substantiating Sleep & Mood Claims
A nutraceutical brand needed to transform promising product concepts into defensible, market-ready claims for their novel wellness formula.
Key Questions:
- Efficacy Validation: Does the product actually work in a real-world setting? Can we objectively measure its impact?
- Claim Substantiation: What specific claims can withstand regulatory scrutiny from bodies like the FTC?
- Target Audience Insights: Who benefits most? What benefits should be highlighted?
- Product Roadmap: Do results suggest formulation tweaks or line extensions?
Our Solution: Dual-Validated Study
Reputable executed a comprehensive study confirming key outcomes via both objective wearable data and subjective surveys to ensuring high-confidence results.
Design & Recruitment
Recruited a diverse cohort (83% Caucasian, broad income range) to test the formulation in a real-world home setting.
Intervention & Tracking
Participants used the product while tracking sleep biomarkers (latency, efficiency) via wearables and completing PSQI surveys.
Analysis
Statistical analysis of pre- vs. post-intervention data to validate efficacy for sleep initiation and emotional well-being.
The Results & Business Impact
The study delivered strong dual-validation, showing significant improvements in objective sleep metrics and subjective quality of life.
Objective Biomarker Metrics
Wearable data showed impressive improvements in sleep mechanics, particularly for sleep onset and maintenance.
Participant Improvement Rates
| Metric | % Change | % Improved |
|---|---|---|
| Sleep Latency | -10.70% | 71% |
| Time Awake | -9.37% | 75% |
| Sleep Efficiency | +1.09% | 71% |
Data from wearable sensors
Validated Survey Data (PSQI)
Subjective feedback via the Pittsburgh Sleep Quality Index confirmed the objective findings with high statistical significance.
PSQI Component Change
| Component | Improvement | p-value |
|---|---|---|
| Sleep Latency | -33.33% | 0.005 |
| Global PSQI Score | -11.98% | 0.051 |
| Sleep Quality | -18.18% | 0.109 |
Both objective and subjective data confirm faster sleep onset.
— Final Verification Report
Key Business Outcomes
Evidence-Backed Claims
Gained defensible data to market claims like "helps reduce time to fall asleep" and support improved sleep efficiency.
Strategic Marketing
Holistic narrative targeting consumers with stress-related sleep issues, backed by emotional well-being data.
Retailer Confidence
Professional, data-driven reports built credibility and facilitated distribution conversations with retailers.
Informed Development
Validated the current formulation and provided strong rationale for a larger, placebo-controlled trial.
The Reputable Advantage
We don't just provide data, we deliver clarity and confidence. Our platform is built to de-risk product development and empower brands with undeniable proof.
Full-Service Research Partner
We manage everything from study design and recruitment to data analysis and reporting, acting as an extension of your team.
High-Fidelity Real-World Data
We combine objective, 24/7 biometric data from wearables with validated subjective surveys for a complete view of product performance.
Regulatory Confidence
Our platform and methodologies are designed to generate compliance-ready data, ensuring your claims are supported by thorough, defensible evidence.