The Challenge
Validating a Functional Coffee Alternative
Functional Coffee Product, a functional coffee product with adaptogens and nootropics, was developed to enhance energy, focus, and well-being without the typical crash from traditional coffee. The company needed to scientifically validate these benefits.
The primary challenge was to gather robust clinical data to substantiate their product's claims and understand its specific effects.
Key Questions:
- Clinical Efficacy: Does daily consumption improve digestive symptoms, anxiety, and depression?
- Physiological Impact: Can objective changes in sleep, heart rate, or autonomic balance be measured using wearables?
- Market Credibility: How can they generate high-quality, placebo-controlled data to build consumer trust and support marketing claims?
- Safety Profile: Is the product safe and well-tolerated for daily consumption in a healthy adult population?
Our Solution: A Rigorous RCT
Reputable designed and executed a 28-day, randomized, double-blind placebo-controlled trial to rigorously evaluate the impact of the Functional Coffee Product. Our end-to-end platform managed the entire study, from recruitment to final analysis.
01
Participant Recruitment & Baseline
70 healthy adults were enrolled and randomized into two groups: one receiving the Functional Coffee Product and one receiving a placebo. Baseline data was collected using validated PROMIS surveys and Oura Ring wearables.
02
28-Day Intervention & Data Capture
Participants consumed their assigned product daily. Throughout the study, objective biometric data (sleep, HRV, HR) was passively collected 24/7 using Oura Ring wearable sensors.
03
Final Analysis & Reporting
At day 28, participants completed the final surveys. Our data scientists performed non-parametric and parametric statistical analyses to deliver a comprehensive final report.