The global nutraceutical industry, valued at over $400 billion, is projected to grow rapidly as people shift toward preventive and holistic health solutions. From probiotics and vitamins to omega-3 and collagen, nutraceuticals are now a core part of everyday health. However, consumer trust hinges on one factor: proof. This is where nutraceutical clinical trials become invaluable.
At ProRelix Research, we provide specialized CRO services for nutraceutical products, enabling supplement companies to build evidence-based claims and secure their position in a crowded market.
Do Nutraceuticals Need Clinical Trials?
Though nutraceuticals are generally classified as dietary supplements and don’t always require pre-market clinical trials, consumer expectations have changed. Studies now help:
- Establish proof of health claims
- Provide competitive differentiation
- Ensure safe dosing and ingredient synergy
- Attract funding, licensing, or M&A opportunities
- Boost retail and online conversions with data-backed messaging
Thus, partnering with a CRO for dietary supplement trials is no longer just optional—it’s a smart business move.
Regulatory Requirements and Challenges
Nutraceuticals face varying global regulations. In the U.S., the DSHEA (1994) governs them, allowing marketers to make “structure/function” claims (e.g., “supports heart health”) without FDA approval. However, the moment a therapeutic claim is made, clinical evidence becomes necessary.
Our team understands these nuances and offers precise guidance on where and when clinical data is essential.
Obstacles to Nutraceutical Studies
Unlike drugs, nutraceuticals often take longer to show effects. Some common challenges include:
- Long study durations to see benefits in immunity, metabolism, etc.
- Difficulty blinding participants due to taste or odor
- Higher dropout rates for preventive trials
- Regulatory ambiguity across different countries
As a result, choosing experienced CRO services for nutraceutical products is vital to control costs, time, and trial quality.
Our Full-Service Offerings
ProRelix Research provides customized solutions:
1. Protocol & Study Design
We focus on clinically relevant endpoints for nutrition and wellness—like fatigue reduction, metabolic rate, digestive health, and more.
2. Site & Participant Management
We collaborate with a global site network and target populations such as athletes, seniors, or individuals with metabolic syndromes.
3. Regulatory Filings & IRB Applications
We help you prepare and submit ethical documents for approval, including claim substantiation reports for marketing.
4. Statistical Analysis & Publications
From pre-study sample size calculation to final data visualization, we offer end-to-end analytics.
5. Post-Trial Support
This includes label claim support, investor presentations, and Clinical Trial Applications (CTA) for international expansion.
Our Quality Standards
We conduct trials under ICH-GCP compliance, giving your nutraceutical brand global credibility and alignment with pharmaceutical-grade quality standards.
Why ProRelix Research?
- 10+ years in the health science domain
- Global database of healthy and target-specific volunteers
- Budget-friendly and flexible models
- Expertise in probiotics, collagen, nootropics, omega-3, and plant-based nutraceuticals
- Experience with DSHEA-compliant study design and EFSA claims
Turn Your Product Into a Science-Backed Success
In a market where every product claims to be the best, the truth is in the data. Clinical research can unlock your brand’s full potential. Let us, as a proven CRO for dietary supplement trials, guide your next step.
Talk to us now for a free feasibility assessment.
