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.

Magnesium: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Sleep & Relaxation

Typical Dosage

200–400 mg/day (elemental magnesium)

Common Forms

Magnesium glycinate (bisglycinate)

What Is Magnesium?

Magnesium is an essential mineral involved in over 300 enzymatic reactions in the body. It's critical for muscle and nerve function, blood sugar regulation, blood pressure management, and protein synthesis. An estimated 50% of the US population doesn't meet the recommended daily intake.

Mechanism of action: Magnesium acts as a cofactor for over 300 enzymes, including those involved in ATP production, DNA synthesis, and neurotransmitter release. It modulates NMDA receptors and GABA activity, contributing to its calming and sleep-supporting effects. Different chelated forms have varying bioavailability and tissue distribution.

Clinical Evidence Summary

Below are 5 key clinical studies on Magnesium. Nutra Comp analyses 89+ studies in its full clinical evidence report.

Systematic review and meta-analysis2021PMID: 33865176

The Effect of Magnesium Supplementation on Sleep Quality: A Systematic Review and Meta-Analysis

Population: 7 RCTs, 7,582 participants

Key finding: Magnesium supplementation showed a statistically significant effect on subjective sleep quality measures (PSQI scores improved, p=0.03).

Meta-analysis2016PMID: 27933574

Effect of Magnesium Supplementation on Blood Pressure: A Meta-Analysis

Population: 34 RCTs, 2,028 participants

Key finding: Magnesium supplementation at median 368 mg/day significantly reduced systolic BP by 2.00 mmHg and diastolic BP by 1.78 mmHg.

RCT2014PMID: 25540137

Magnesium supplementation and the effects on muscle performance

Population: 23 male athletes

Key finding: Magnesium supplementation (8 mg/kg/day) for 7 days significantly reduced lactate production during submaximal exercise (p<0.05).

Systematic review2019PMID: 31691193

Oral magnesium supplementation for treating glucose metabolism parameters in people with or at risk of diabetes

Population: 18 RCTs

Key finding: Magnesium supplementation significantly reduced fasting glucose (p=0.001) and improved insulin sensitivity markers in those at risk of diabetes.

Systematic review2020PMID: 32914701

Association between Magnesium Intake and Depression in Adults

Population: Multiple observational and RCT studies

Key finding: Higher magnesium intake was associated with lower risk of depression. Supplementation studies showed improvement in mild-to-moderate depressive symptoms.

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 sleep quality and restfulness”

Category: Sleep · Confidence: 7/10

“Supports healthy muscle function and relaxation”

Category: Muscle Function · Confidence: 9/10

“Supports cardiovascular health and healthy blood pressure already within the normal range”

Category: Cardiovascular · Confidence: 7/10

Get the full substantiation report for Magnesium

Includes all 89+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Ashwagandha

34 studies · Stress & Anxiety

Vitamin D3

127 studies · Bone Health & Calcium Metabolism

Zinc

92 studies · Immune Function

Key Terms

Structure–Function Claim Meta-Analysis P-Value

Frequently Asked Questions

Is magnesium FDA approved?

Magnesium is an essential mineral sold as a dietary supplement. It does not require FDA approval. The FDA has established a Daily Value (DV) of 420 mg for adults.

What are the most studied benefits of magnesium?

The strongest evidence supports magnesium's role in sleep quality improvement, muscle function, blood pressure support, and glucose metabolism. Different forms (glycinate, citrate, threonate) may have varying effects.

What dosage of magnesium is used in clinical studies?

Most clinical trials use 200–400 mg/day of elemental magnesium. The specific form matters: magnesium glycinate and citrate are more bioavailable than oxide.

Stop Spending Weeks on Substantiation

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