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.

Green Tea Extract: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Metabolic Support

Typical Dosage

250–500 mg EGCG/day

Common Forms

Standardised EGCG extract

What Is Green Tea Extract?

Green tea extract (Camellia sinensis) is rich in catechins, particularly EGCG (epigallocatechin gallate). Clinical research supports its effects on antioxidant protection, metabolic rate, weight management, and cardiovascular health.

Mechanism of action: EGCG inhibits catechol-O-methyltransferase (COMT), prolonging norepinephrine signalling and increasing thermogenesis. It activates AMPK, enhances fat oxidation, and provides potent antioxidant activity through hydrogen donation and metal chelation.

Clinical Evidence Summary

Below are 3 key clinical studies on Green Tea Extract. Nutra Comp analyses 86+ studies in its full clinical evidence report.

Meta-analysis2017PMID: 28627214

Green tea catechins and body weight: a systematic review

Population: 15 RCTs, 1,945 participants

Key finding: Green tea catechins with caffeine significantly reduced body weight (WMD: -1.38 kg, p<0.001) versus control over 12 weeks.

Meta-analysis2018PMID: 29099763

EGCG and cardiovascular risk factors

Population: 17 RCTs

Key finding: Green tea extract significantly reduced LDL cholesterol (WMD: -4.5 mg/dL, p=0.01) and fasting blood glucose (WMD: -1.6 mg/dL, p<0.05).

Systematic review2019PMID: 30653316

Green tea extract and antioxidant capacity

Population: 12 RCTs

Key finding: Green tea supplementation significantly increased plasma antioxidant capacity and reduced oxidative stress markers (MDA, 8-OHdG).

Evidence-Based Structure–Function Claims

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

“Provides antioxidant support from green tea polyphenols”

Category: Antioxidant · Confidence: 9/10

“Supports healthy metabolism and energy expenditure”

Category: Metabolic · Confidence: 7/10

“Supports cardiovascular health”

Category: Cardiovascular · Confidence: 7/10

Get the full substantiation report for Green Tea Extract

Includes all 86+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Quercetin

36 studies · Immune & Anti-inflammatory

Resveratrol

41 studies · Cardiovascular & Anti-ageing

Caffeine

450 studies · Focus & Physical Performance

Key Terms

Bioavailability Standardised Extract Dose-Response Relationship

Frequently Asked Questions

Is green tea extract FDA approved?

Green tea extract is a dietary supplement under DSHEA. FDA has issued safety guidance regarding high-dose EGCG supplements and liver safety.

What are the most studied benefits?

The strongest evidence supports green tea extract for antioxidant protection, modest weight management support, and cardiovascular risk factor improvement.

What dosage is used in clinical studies?

Most studies use 250–500 mg EGCG per day. Doses above 800 mg EGCG/day have been associated with liver toxicity risk.

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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