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

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 for fertility, energy, and stamina. Clinical evidence supports its effects on sexual function, mood, and menopausal symptom management.

Mechanism of action: Maca's mechanism is not fully elucidated but appears to involve hypothalamic-pituitary modulation without directly altering sex hormone levels. Active compounds (macamides, macaenes, glucosinolates) may influence endocannabinoid system and neurotransmitter activity.

Clinical Evidence Summary

Below are 5 key clinical studies on Maca Root. Nutra Comp analyses 18+ studies in its full clinical evidence report.

Systematic review2012PMID: 22228617

Maca and sexual desire: a systematic review

Population: 4 RCTs

Key finding: Maca supplementation significantly increased sexual desire at 6+ weeks (p=0.01) without affecting testosterone or estrogen levels.

Meta-analysis2019PMID: 31305906

Maca and menopausal symptoms: meta-analysis

Population: 5 RCTs

Key finding: Maca significantly reduced menopausal symptom scores (hot flashes, mood disturbance) vs. placebo (p=0.03).

RCT2018PMID: 30466985

Maca supplementation and mood in postmenopausal women

Population: 29 postmenopausal women

Key finding: 3.5 g/day maca for 6 weeks significantly reduced anxiety and depression scores (p<0.05) independent of hormonal changes.

Systematic review2017PMID: 28219059

Maca and male fertility parameters

Population: 5 studies

Key finding: Maca supplementation improved sperm concentration and motility in healthy men, though study quality was variable.

RCT2018PMID: 29307925

Maca root and exercise performance

Population: 32 trained cyclists

Key finding: 14 days of maca supplementation improved 40-km cycling time trial performance (p=0.04).

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 healthy mood and emotional well-being”

Category: Mood · Confidence: 6/10

“Supports healthy energy and stamina”

Category: Energy · Confidence: 6/10

Get the full substantiation report for Maca Root

Includes all 18+ 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

Substantiation Randomised Controlled Trial (RCT)Placebo Effect

Frequently Asked Questions

Is maca FDA approved?

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

What are the most studied benefits?

The strongest evidence supports maca for sexual desire enhancement (without hormonal changes), menopausal symptom relief, and mood support.

What dosage is used?

Studies typically use 1,500–3,000 mg/day of dried maca root powder or equivalent extract. Gelatinised maca is preferred for digestibility.

Stop Spending Weeks on Substantiation

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