Validating Dietary Nitrate Supplementation for Female Sexual Health
See how Reputable's rigorous, placebo-controlled trial provided a leading wellness brand with the scientific evidence needed to explore the effects of their nitrate formulation on female sexual wellness.
Significant improvement in the FSFI Desire domain compared to placebo (p=0.017).
Total FSFI score improvement was nearly double the placebo group.
A randomized, placebo-controlled trial design provided high-quality evidence.
Generating Evidence for a Nitrate Formulation
A wellness brand sought to validate their dietary nitrate supplement's impact on female sexual function. To build trust with consumers and practitioners, they needed high-quality, placebo-controlled data.
Key Questions:
- Clinical Efficacy: Does daily nitrate supplementation tangibly improve desire, arousal, and orgasm?
- Objective Changes: Can we detect physiological changes in sleep or cardiovascular metrics?
- Market Credibility: How can we build trust with consumers through rigorous data?
- Broad Applicability: Are benefits consistent across different age groups?
Our Solution: A 30-Day RCT
Reputable executed a randomized, placebo-controlled trial to measure the formulation's effects over a 30-day intervention period, capturing both subjective FSFI scores and objective wearable data.
Design & Recruitment
Participants were recruited and randomized into Nitrate vs. Placebo groups. Demographics were 80% Caucasian with a broad age range.
30-Day Intervention
Daily supplementation with passive biometric tracking (Heart Rate, Sleep) and validated FSFI surveys.
Analysis
Statistical comparison of FSFI domains (Desire, Satisfaction, Lubrication) and biomarker safety metrics.
The Results & Business Impact
The study successfully demonstrated significant improvements in key sexual health domains while confirming the product's safety profile through stable biomarker data.
Primary Outcome: Desire
The Nitrate group showed a statistically significant improvement in the FSFI Desire domain compared to the Placebo group.
Mean FSFI Desire Rank
* p-value = 0.017 (Significant)
Biomarker Safety Monitoring
Objective wearable data confirmed no adverse effects on heart rate or sleep patterns, supporting the product's safety.
Objective Metrics (Mean)
| Metric | Nitrate | Placebo | Status |
|---|---|---|---|
| Avg Heart Rate | 67.03 | 63.27 | Stable (p=0.138) |
| REM Sleep (hrs) | 1.58 | 1.52 | Stable (p=0.468) |
| Deep Sleep (hrs) | 1.17 | 1.15 | Stable (p=0.840) |
No significant negative deviation in cardiovascular or sleep metrics vs placebo.
— Final Verification Report
Key Business Outcomes
Credible Narrative
Statistically significant results in the Desire domain provide a powerful, evidence-based foundation for consumer education and marketing.
Validation of Formulation
Validates that the current formulation can produce clinically meaningful changes within 30 days, supporting usage instructions.
Informed Innovation
Provides a rationale for future research and formulation enhancements, such as combining nitrate with synergistic ingredients.
Broad Market Potential
Results were consistent across age groups, suggesting the product has broad applicability for adult women.
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.