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.

Myo-Inositol: Clinical Evidence & Substantiation Summary

Clinical Trials

118

Strongest Evidence

Women's & Metabolic Health

Typical Dosage

2,000–4,000 mg/day

Common Forms

Myo-inositol powder

What Is Myo-Inositol?

Myo-inositol is a naturally occurring sugar alcohol that acts as a second messenger in intracellular signaling, particularly for insulin and follicle-stimulating hormone (FSH). It is one of the most studied supplements for metabolic and reproductive health.

Mechanism of action: Inositol-based signaling molecules (IP3, PIP3) mediate the cellular response to insulin, promoting glucose uptake and glycogen synthesis. In the ovaries, myo-inositol increases insulin sensitivity and regulates FSH signaling, supporting healthy ovulation.

Clinical Evidence Summary

Below are 3 key clinical studies on Myo-Inositol. Nutra Comp analyses 118+ studies in its full clinical evidence report.

Meta-analysis2017PMID: 29042448

Myo-inositol and D-chiro-inositol for PCOS: meta-analysis

Population: 10 RCTs

Key finding: Inositol supplementation significantly improved ovulation rates, reduced androgen levels, and improved metabolic parameters in women with PCOS (p<0.001).

Meta-analysis2019PMID: 31310662

Myo-inositol for metabolic syndrome: meta-analysis

Population: 14 RCTs

Key finding: Myo-inositol supplementation significantly reduced hba1c, fasting glucose, and blood pressure (p<0.01) across diverse populations.

Systematic review2021PMID: 33992294

Myo-inositol and anxiety: systematic review

Population: 7 studies

Key finding: High-dose myo-inositol (12–18 g/day) showed therapeutic efficacy for panic disorder and OCD comparable to some SSRIs, with fewer side effects.

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 reproductive hormones and ovulation”

Category: Women's Health · Confidence: 9/10

“Supports healthy insulin sensitivity and glucose metabolism”

Category: Metabolism · Confidence: 9/10

“Supports healthy cellular signaling and neurotransmitter balance”

Category: Mood · Confidence: 7/10

Get the full substantiation report for Myo-Inositol

Includes all 118+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Vitamin D3

127 studies · Bone Health & Calcium Metabolism

Berberine

47 studies · Blood Sugar Support

Chromium

64 studies · Blood Sugar Management

Key Terms

Meta-Analysis Bioavailability Clinically Effective Dose

Frequently Asked Questions

Is inositol FDA approved?

Inositol is classified as a dietary supplement and has GRAS status. It does not have an RDA and is not FDA approved as a drug.

What is the difference between Myo and D-Chiro?

Myo-inositol is a general signaling molecule; D-chiro-inositol is specifically involved in glycogen synthesis. The body maintains a 40:1 ratio (Myo:D-chiro), which is the ratio often used in clinical studies.

Can it help with cravings?

By improving insulin sensitivity and stabilizing blood sugar signaling, many users and clinicians report reduced sugar cravings and better appetite control.

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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