Case Study
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 and related health outcomes.
Statistically Significant Outcomes
Enhanced Desire
Significant improvement in the Desire domain compared to placebo.
p=0.017
Clinically Meaningful
Total FSFI score improvement was nearly double the placebo group.
RCT Validated
A randomized, placebo-controlled trial design provided high-quality evidence for the observed outcomes.
The Challenge: Substantiating a Novel Approach to Female Wellness
A leader in nitric oxide supplements developed a dietary nitrate formulation with the potential to support female sexual function. While the link between nitric oxide, blood flow, and sexual response is established, they needed rigorous scientific evidence to explore their product's specific effects.
The core challenge was to move beyond theory and generate robust clinical data to answer key questions:
- Clinical Efficacy: Does daily nitrate supplementation tangibly improve key domains of female sexual function like desire, arousal, and orgasm?
- Objective Changes: Can we detect physiological changes in sleep or cardiovascular metrics that correlate with these improvements?
- Market Credibility: How can we generate high-quality, placebo-controlled data to build trust with consumers and practitioners?
- Broad Applicability: Are the potential benefits consistent across different age groups of adult women?
Our Solution: A Rigorous Randomized Controlled Trial (RCT)
Reputable designed and executed a 30-day, randomized, placebo-controlled trial to rigorously evaluate the impact of a leading nitrate supplement. Our end-to-end platform managed the entire study, from recruitment to final analysis.
Methodology Deep Dive
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Participant Recruitment & Baseline
70 adult women were enrolled and randomized into two groups: one receiving the active dietary nitrate supplement and one receiving a placebo. Baseline data was collected using the validated Female Sexual Function Index (FSFI) survey.
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30-Day Intervention & Data Capture
Participants took their assigned supplement daily for 30 days. Throughout the study, objective biometric data (sleep, HRV, HR) was passively collected using Oura Ring wearable sensors.
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Final Analysis & Reporting
At day 30, participants completed the FSFI survey again. Our data scientists performed between-group statistical analyses (T-tests, Mann-Whitney U) to deliver a comprehensive final report.
The Results & Business Impact
The study provided compelling preliminary evidence that dietary nitrate supplementation can positively impact key areas of female sexual function, delivering a clear ROI.
"A significant between-group difference was observed in the FSFI Orgasm domain (p=0.016), indicating that participants in the nitrate group experienced notably greater improvement in orgasmic function compared to placebo."
— Reputable Final Report
Key Business Outcomes:
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✓
Credible, Science-Backed Narrative: The statistically significant results in the Orgasm and Desire domains provide a powerful, evidence-based foundation for consumer education and marketing.
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Validation of Formulation: The findings validate that the current formulation can produce clinically meaningful changes within 30 days, supporting product usage instructions and efficacy.
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✓
Informed Innovation: The study provides a strong rationale for future research and supports exploring formulation enhancements, such as combining nitrate with other synergistic ingredients.
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Broad Market Potential: The finding that age did not significantly predict outcomes suggests the product has broad applicability for adult women, widening the potential target market.
Data Highlights from the Final Report
The study produced clear, multi-layered data. Here is a sample of the key demographic and outcome measures.
Study Demographics (n=50)
Ethnicity
- 80% Caucasian or White
- 8% Hispanic or Latino
- 12% Other
Income
- 53% $100k - $500k
- 10% $50k - $100k
- 10% > $500k
- 6% $25k - $50k
- 6% < $25k
- 16% Prefer not to state
Subjective Survey Data (FSFI)
| FSFI Domain | Mean Ranks (Nitrate vs. Placebo) | p-value |
|---|---|---|
| Desire | 30.36 vs. 20.64 | 0.017 |
| Satisfaction | 26.62 vs. 24.38 | 0.584 |
| Lubrication | 26.26 vs. 24.74 | 0.711 |
*Higher mean rank indicates greater improvement. A p-value < 0.05 is statistically significant.
Objective Wearable Data (End-of-Study)
| Biomarker Metric | Nitrate Group (Mean) | Placebo Group (Mean) | p-value |
|---|---|---|---|
| Avg Heart Rate | 67.03 | 63.27 | 0.138 |
| REM Sleep (hrs) | 1.58 | 1.52 | 0.468 |
| Deep Sleep (hrs) | 1.17 | 1.15 | 0.840 |
*No statistically significant differences were detected in objective metrics, though some trends favored the nitrate group.
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 with validated subjective surveys for a complete, multi-layered 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.
Ready to validate your wellness product?
Let's build the evidence you need to lead the market. Schedule a free strategy session with our research experts to discuss your goals and how we can help you achieve them.
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