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.

Tribulus Terrestris: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Sexual Health & Libido

Typical Dosage

250–1,500 mg/day

Common Forms

Standardised to 45% saponins

What Is Tribulus Terrestris?

Tribulus terrestris is a plant traditionally used in Ayurveda and traditional Chinese medicine for vitality and reproductive health. Clinical evidence shows mixed results for testosterone but consistent benefits for sexual function and libido.

Mechanism of action: Tribulus saponins (particularly protodioscin) may enhance androgen receptor density and sensitivity. It supports nitric oxide production via endothelial function. Despite marketing claims, most clinical trials show no significant effect on serum testosterone levels in healthy men.

Clinical Evidence Summary

Below are 3 key clinical studies on Tribulus Terrestris. Nutra Comp analyses 19+ studies in its full clinical evidence report.

Systematic review2016PMID: 27710902

Tribulus terrestris for sexual dysfunction: a systematic review

Population: 11 RCTs

Key finding: Tribulus supplementation improved sexual desire and satisfaction scores in both men and women, though effect sizes were modest (SMD 0.42, p=0.02).

Meta-analysis2019PMID: 31062369

Effect of Tribulus on testosterone levels: a meta-analysis

Population: 7 RCTs, 284 men

Key finding: Tribulus did NOT significantly increase total testosterone (WMD: 0.32 nmol/L, p=0.45) in healthy men across pooled trials.

RCT, double-blind2018PMID: 29473879

Tribulus terrestris and female sexual function

Population: 60 menopausal women

Key finding: 750 mg/day Tribulus for 120 days significantly improved desire, arousal, and satisfaction domains of the FSFI (p<0.01).

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 libido and sexual function”

Category: Sexual Health · Confidence: 7/10

“Supports vitality and overall well-being”

Category: General Health · Confidence: 5/10

Get the full substantiation report for Tribulus Terrestris

Includes all 19+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Ashwagandha

34 studies · Stress & Anxiety

Zinc

92 studies · Immune Function

Maca Root

22 studies · Sexual Health & Libido

Key Terms

Randomised Controlled Trial (RCT)Placebo Effect Clinical Trial

Frequently Asked Questions

Does Tribulus increase testosterone?

Meta-analyses show Tribulus does NOT significantly increase testosterone in healthy men. Its sexual health benefits appear to work through other mechanisms, including nitric oxide support and androgen receptor sensitivity.

What are the most studied benefits?

The strongest evidence supports Tribulus for sexual desire and satisfaction in both men and women, rather than testosterone enhancement.

What dosage is used in clinical studies?

Most studies use 250–1,500 mg/day of extract standardised to 45% saponins. Sexual function studies typically use 750–1,500 mg/day.

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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