Case Study: Functional Coffee Product RCT Final Report

Case Study

A Randomized Control Trial on a Functional Coffee Alternative

Discover how Reputable's placebo-controlled trial provided Functional Coffee Product with the scientific evidence to evaluate their product's effects on digestive health, mood, and sleep.

Statistically Significant Outcomes

Improved REM Sleep

The active group showed a significant increase in restorative REM sleep duration.

p=0.014

Better Gut & Mood

Participants reported significant improvements in belly pain, gas/bloating, anxiety, and depression.

Safe & Well-Tolerated

No adverse effects were reported, supporting the safety of the Functional Coffee Product for daily use and highlighting product quality.

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:

  • 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 Randomized Controlled Trial (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.

Methodology Deep Dive

  1. 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.

  2. 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.

  3. 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.

The Results & Business Impact

The study provided compelling preliminary evidence that the Functional Coffee Product can positively impact key areas of well-being, delivering a clear ROI for future development and marketing.

"Within-group analyses... showed increased REM sleep in the Functional Coffee Product group (p=.014), alongside favorable but non-significant improvements in sleep efficiency and average heart rate."

— Functional Coffee Product Final Report

Key Business Outcomes:

  • ✓
    Evidence-Based Marketing: The results provide a credible, science-backed foundation for consumer messaging centered on digestive comfort, mood balance, and sleep support.
  • ✓
    Product Formulation Validated: The findings support the utility of the functional coffee formulation for promoting daily balance, energy, and wellness.
  • ✓
    Informed Innovation: The study highlights opportunities for line extensions (e.g., with probiotics) and deeper user engagement through digital tools, strengthening product differentiation.
  • ✓
    Confirmed Safety Profile: The absence of adverse effects reinforces the product's safety for daily use, a critical factor for consumer trust and market positioning.

Data Highlights from the Final Report

The study produced clear, multi-layered data. Here is a sample of the key demographic and outcome measures for the 50 participants who completed the study.

Study Demographics

Ethnicity

Household Income

Subjective Improvements (PROMIS)

*Within-participant change from baseline for the Functional Coffee Product group. A p-value < 0.05 is statistically significant.

Objective Improvements (Wearable)

*Within-participant change from baseline for the Functional Coffee Product 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 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.

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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