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Be Part of the Future of Health Research
Whether you're a researcher or participant, Alethios makes health research effortless and impactful.
Scientific claims build trust, boost conversions, and unlock retail and investor confidence. Learn how to scale your evidence—starting small and climbing toward gold-standard proof using Alethios’ Research Thermometer.
Whether you're developing a supplement, skincare line, or functional food product, substantiated claims are your bridge between science and consumer trust. Claims like “clinically proven to reduce wrinkles,” “supports digestion,” or “improves focus” don’t just boost conversion rates – they build long-term brand credibility.
Research from the International Food Information Council (IFIC) has shown that consumers increasingly seek out products backed by science. Retail buyers and regulators are doing the same. Substantiated claims allow:
- Stronger positioning in crowded categories
- Higher pricing power
- Improved retail sell-in and investor confidence
- Reduced legal and regulatory risk
Yet the traditional path to a claim – long, expensive randomized controlled trials (RCTs) – has kept most early and growth-stage brands from engaging in this process. That’s changing.
Before diving into study design, it’s essential to understand what counts as a claim – and what level of substantiation different jurisdictions expect.
In the U.S.:
- FDA oversees “structure/function claims” (e.g., “supports immune health”) for dietary supplements and foods, requiring substantiation that the claim is truthful and not misleading.
- FTC enforces “advertising claims” and expects “competent and reliable scientific evidence” – usually defined as well-controlled human studies.
In the EU:
- EFSA applies a high bar for health claims, requiring human studies with statistically significant results that match the proposed claim wording.
Understanding these frameworks helps you reverse-engineer your approach. Not every claim needs an RCT, but every claim needs *supporting evidence*.
At Alethios, we use what we call the Research Thermometer – a mental model for building toward proof.
🌡️ Base of the Thermometer: Early-Stage, Exploratory
- Observational studies
- Self-reported outcomes
- Pre/post product testing
- Wearable-driven signals (e.g., sleep trackers, HRV, skin sensors)
Ideal for:
- Getting fast signal on efficacy
- Informing formulation and messaging
- Creating data-backed brand content (not always suitable for on-pack claims)
🌡️ Mid-Tier: Structured Observational and Controlled Designs
- Open-label studies with control groups
- In-home usage tests with defined protocols
- Structured testimonial collection
Ideal for:
- Building preliminary support for on-pack claims
- Gaining buyer and investor confidence
- Informing claim wording and marketing narratives
🌡️ Top of the Thermometer: Gold-Standard Proof
- Randomized Controlled Trials (RCTs)
- Double-blind, placebo-controlled studies
- Statistically significant endpoints linked to claim language
Ideal for:
- Regulatory approval (especially in EU)
- Defensibility in high-risk categories
- Flagship claims for hero products
The key insight: you don’t need to start at the top. You can – and often should – climb the thermometer (or as our CEO said at ExpoWest, research can be both a thermometer and a ladder - folks start at different temperatures and rungs!)
If you're launching a new product or iterating a formulation, start with:
Observational Studies
- Participants use the product and report outcomes over time
- Can include wearable integrations for objective data
- Often used in sleep, stress, mood, and digestion categories
Open-Label Studies
- All participants know what product they’re receiving, and they can still be randomized to which intervention it might be
- Allows rapid feedback collection
- Ideal for newer brands or product-market fit exploration
Pre/Post Designs
- Measure change before and after product use (e.g., hydration level, skin firmness)
- Adds structure to observational studies
These are lower-cost, faster to execute, and highly flexible.
Let’s say you’re developing a daily gut health powder. Here’s how you might climb the thermometer:
1. Phase 1: 30-person observational study over 4 weeks
- Track bloating, digestion, and energy levels
- Use surveys + GI symptom scoring tools
2. Phase 2: Structured split-panel study
- One group gets the product, one doesn’t (no blinding)
- Compare self-reported symptoms and bowel movement quality
3. Phase 3: RCT with validated outcomes
- 100+ participants, double-blind
- Use Bristol stool chart, gut microbiome testing, and validated GI surveys
Each phase informs the next – and generates content and insight along the way.
With Alethios, studies can start as low as $3K for pilots, compared to the $200K+ price tags associated with CRO-led trials.
Typical study timelines:
- Observational: 4–8 weeks
- Controlled usage tests: 6–10 weeks
- RCTs: 4–6 months (with protocol development, IRB, and recruitment)
We also streamline:
- IRB approval
- Participant recruitment (via AI targeting + our network)
- Data collection through wearables, mobile, and verified surveys
1. Waiting too long to start – Start with pilot signals and evolve.
2. Assuming only RCTs matter – Claims are a continuum. Build toward proof.
3. Not aligning study design with marketing goals – Make sure your endpoints map to your messaging.
4. Overlooking participant diversity – Data needs to reflect your target audience, or it won’t scale.
Here are three questions to ask your team:
1. What benefits do we *want* to claim?
2. What level of evidence do we *need* to support that claim?
3. What kind of study design fits our budget, timeline, and marketing roadmap?
You don’t need a CRO or an academic lab to get started. You just need the right framework – and the right partner.
Ready to design a study or claim development roadmap?
If you’d like to try our AI Study Quickstart, here is a link to skip the waitlist.
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Whether you're a researcher or participant, Alethios makes health research effortless and impactful.
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