What is supplement substantiation?

Substantiation is the process of gathering and documenting scientific evidence that supports the health claims you make on your supplement labels and marketing materials. The FDA requires that all structure–function claims be truthful, non-misleading, and substantiated by competent and reliable scientific evidence — typically clinical trials on healthy human subjects.

How does Nutra Comp's AI analysis work?

Nutra Comp searches PubMed for clinical trials relevant to your ingredient, filters for studies on healthy human subjects with oral administration, and uses AI to extract key data: p-values, effect sizes, study design, population details, and conclusions. It distinguishes between across-group and within-group significance and ranks evidence strength with a confidence scoring system.

What data sources does Nutra Comp use?

Nutra Comp primarily searches PubMed/MEDLINE, the world's largest biomedical literature database maintained by the U.S. National Library of Medicine. We focus on peer-reviewed clinical trials, randomised controlled trials (RCTs), meta-analyses, and systematic reviews.

Are the generated claims FDA-compliant?

Yes. Nutra Comp generates structure–function claims in strict accordance with the FDA Small Entity Compliance Guide. All claims avoid explicit and implicit disease references. However, we recommend having your legal/regulatory team review the final output before use, as Nutra Comp is a tool to assist — not replace — professional compliance review.

How long does a typical ingredient search take?

Most ingredient searches complete within 5–15 minutes, depending on the volume of clinical literature available. Compare this to the typical manual process which can take 40–100+ hours per ingredient when done by a human compliance expert.

Can I export my reports?

Absolutely. All clinical evidence reports, structure–function claims, and substantiation memos can be exported as professional PDF documents. These are formatted for easy sharing with your legal team, regulatory reviewers, or business partners.

What does 'ingredient searches per month' mean?

Each search is one ingredient analysis — for example, searching 'Ashwagandha' or 'Vitamin D3'. The search generates a complete evidence report, claims, and substantiation memo for that ingredient. Your monthly allowance resets on your billing date.

When will Nutra Comp be available?

We're currently in private beta. Join the waitlist to get early access and be notified when we launch. Early waitlist members will receive priority access and special launch pricing.

Phosphatidylserine: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Cognitive Function

Typical Dosage

100–300 mg/day

Common Forms

Soy-derived PS

What Is Phosphatidylserine?

Phosphatidylserine (PS) is a phospholipid essential for cell membrane integrity and signalling. It has a unique FDA qualified health claim for cognitive function and is one of the few nutrients with this distinction for brain health.

Mechanism of action: PS is a critical component of neuronal cell membranes, supporting neurotransmitter release, receptor sensitivity, and synaptic plasticity. It modulates cortisol secretion and supports glucose metabolism in the brain. PS activates protein kinase C, crucial for memory formation.

Clinical Evidence Summary

Below are 3 key clinical studies on Phosphatidylserine. Nutra Comp analyses 24+ studies in its full clinical evidence report.

RCT, double-blind2015PMID: 25933483

Phosphatidylserine and cognitive function in elderly

Population: 78 elderly with mild cognitive decline

Key finding: 300 mg/day PS for 6 months significantly improved memory recall, attention, and verbal fluency versus placebo (p<0.05).

RCT2019PMID: 30516397

PS supplementation and cortisol response to exercise stress

Population: 40 athletes

Key finding: 400 mg/day PS blunted exercise-induced cortisol rise by 20% (p<0.05) and improved perceived wellness after intense training.

RCT, double-blind2017PMID: 28155037

Phosphatidylserine and ADHD symptoms in children

Population: 36 children

Key finding: 200 mg/day PS significantly improved attention, impulsivity scores, and short-term auditory memory after 2 months versus placebo.

Evidence-Based Structure–Function Claims

Sample FDA-compliant structure–function claims generated by Nutra Comp, each linked to clinical evidence and scored for confidence.

“Supports cognitive function and memory”

Category: Cognitive · Confidence: 8/10

“Supports mental clarity and focus”

Category: Cognitive · Confidence: 7/10

“Supports a healthy cortisol response to occasional stress”

Category: Stress · Confidence: 6/10

Get the full substantiation report for Phosphatidylserine

Includes all 24+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Omega-3 Fatty Acids

214 studies · Cardiovascular Health

Lion's Mane

18 studies · Cognitive Function

Bacopa Monnieri

46 studies · Memory & Cognitive Function

Key Terms

Randomised Controlled Trial (RCT)Qualified Health Claim Placebo Effect

Frequently Asked Questions

Is phosphatidylserine FDA approved?

PS has an FDA qualified health claim: 'Phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly.' This is one of very few qualified health claims for cognitive function.

What are the most studied benefits?

The strongest evidence supports PS for memory and cognitive function in elderly populations, cortisol modulation during exercise stress, and attention support in children.

What dosage is used in clinical studies?

Most studies use 100–300 mg/day. The FDA qualified health claim is based on 100 mg/day. Higher doses (300–400 mg) are used in cognitive and cortisol studies.

Stop Spending Weeks on Substantiation

Nutra Comp generates full clinical evidence reports, FDA-compliant structure–function claims, and substantiation memos in minutes — not months.

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