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.

Maca Root: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Sexual Health & Libido

Typical Dosage

1,500–3,000 mg/day

Common Forms

Gelatinised maca powder

What Is Maca Root?

Maca (Lepidium meyenii) is a Peruvian cruciferous root vegetable traditionally used to enhance energy, stamina, and reproductive health. Clinical research supports its effects on libido, mood, and menopausal symptom relief.

Mechanism of action: Maca does not directly affect hormone levels but appears to act on the hypothalamic-pituitary axis, modulating endocrine function. Its active compounds include macamides, macaenes, and glucosinolates that influence neurotransmitter activity and energy metabolism.

Clinical Evidence Summary

Below are 3 key clinical studies on Maca Root. Nutra Comp analyses 22+ studies in its full clinical evidence report.

Systematic review2015PMID: 26421049

Maca and sexual desire: a systematic review

Population: 5 RCTs

Key finding: Maca supplementation significantly improved sexual desire after at least 6 weeks (p<0.05), regardless of sex or menopausal status.

RCT, double-blind2017PMID: 29111093

Maca root for menopausal symptoms

Population: 45 postmenopausal women

Key finding: 3.3 g/day gelatinised maca reduced menopausal symptoms (Kupperman index) by 34% versus placebo (p<0.01).

RCT2019PMID: 30547890

Effect of maca on mood and energy in healthy adults

Population: 72 participants

Key finding: Maca supplementation improved energy, mood, and health-related quality of life scores after 12 weeks (p<0.05).

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 energy and stamina”

Category: Energy · Confidence: 6/10

“Supports a healthy mood during menopause”

Category: Hormonal Health · Confidence: 7/10

Get the full substantiation report for Maca Root

Includes all 22+ 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

Panax Ginseng

58 studies · Energy & Cognition

Tribulus Terrestris

19 studies · Sexual Health & Libido

Key Terms

Randomised Controlled Trial (RCT)Placebo Effect Clinically Effective Dose

Frequently Asked Questions

Is maca root FDA approved?

Maca is sold as a dietary supplement under DSHEA. It does not require FDA approval. It has a long history of traditional use in Peru.

What are the most studied benefits of maca?

The strongest evidence supports maca for improving sexual desire, menopausal symptom relief, and mood/energy enhancement.

What dosage of maca is used in clinical studies?

Most studies use 1,500–3,000 mg/day of gelatinised maca powder or equivalent extract, typically for 6–12 weeks.

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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