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.

Fadogia Agrestis: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Energy & Vitality

Typical Dosage

300–600 mg/day

Common Forms

Fadogia root extract

What Is Fadogia Agrestis?

Fadogia agrestis is a West African shrub traditional used for vitality and hormone support. While animal data is very strong, human clinical evidence is currently in its early stages but showing significant promise.

Mechanism of action: Preclinical studies suggest saponins in Fadogia stimulate Leydig cell activity in the testes, increasing steroidogenesis. It may also increase levels of LH (Luteinizing Hormone), the signal from the brain to produce testosterone.

Clinical Evidence Summary

Below are 3 key clinical studies on Fadogia Agrestis. Nutra Comp analyses 8+ studies in its full clinical evidence report.

Animal study2005PMID: 16281084

Hormonal effects of Fadogia in animal models

Population: Rodent model

Key finding: Fadogia extract significantly increased serum testosterone and increased sexual behavioral markers. Note: Human trials are needed to confirm these results.

Observational data2020PMID: 32432219

Fadogia and vitality biomarkers: case series

Population: N=12 self-reporting users

Key finding: Users reported significant improvements in energy and strength. No abnormalities in acute safety markers (ALT, AST) were noted at 600 mg/day.

Toxicology review2019PMID: 31142457

Safety and toxicity of Fadogia agrestis: toxicology review

Population: Animal data

Key finding: High doses (>100 mg/kg in rodents) showed potential markers of kidney stress. High-dose supplementation (>1,000 mg in humans) should be avoided until further human safety data is available.

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 healthy energy and endurance during physical activity”

Category: Performance · Confidence: 6/10

“Supports general vitality and wellness”

Category: Vitality · Confidence: 6/10

“Traditional support for male vitality”

Category: Hormonal · Confidence: 5/10

Get the full substantiation report for Fadogia Agrestis

Includes all 8+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Zinc

92 studies · Immune Function

Boron

18 studies · Bone & Hormonal Health

Tongkat Ali

24 studies · Vitality & Hormonal Health

Key Terms

Bioavailability Standardised Extract Dose-Response Relationship

Frequently Asked Questions

Is Fadogia Agrestis FDA approved?

Fadogia is sold as a dietary supplement under DSHEA. It does not require FDA drug approval and remains at 'investigational' status for many clinicians.

Should I cycle Fadogia?

Due to the early nature of the safety data and potential for adaptational resistance, many experts recommend cycling Fadogia (e.g., 5 days on, 2 days off) and taking periodic breaks from the supplement.

What is the most effective dose?

Most practitioners and emerging protocols use 300 mg to 600 mg per day. Do not exceed the suggested serving size on the product label.

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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