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.

Vitamin K2: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Bone Health

Typical Dosage

100–200 mcg/day (MK-7) or 15–45 mg/day (MK-4)

Common Forms

MK-7 (menaquinone-7)

What Is Vitamin K2?

Vitamin K2 (menaquinone) is a fat-soluble vitamin essential for calcium metabolism, directing calcium to bones and teeth and away from soft tissues like arteries. Unlike K1 (phylloquinone), K2 has unique cardiovascular and bone-specific benefits beyond clotting.

Mechanism of action: Vitamin K2 activates matrix Gla protein (MGP), which inhibits arterial calcification, and osteocalcin, which promotes calcium deposition in bone matrix. MK-7 has a longer half-life than MK-4, providing 24-hour carboxylation activity from a single daily dose.

Clinical Evidence Summary

Below are 5 key clinical studies on Vitamin K2. Nutra Comp analyses 32+ studies in its full clinical evidence report.

Meta-analysis2014PMID: 25540137

Vitamin K2 and bone mineral density: a meta-analysis

Population: 13 RCTs

Key finding: Vitamin K2 supplementation significantly reduced bone mineral density loss at the lumbar spine (p=0.006) and reduced fracture risk by 80% in Japanese studies using MK-4.

Systematic review2019PMID: 30547890

Vitamin K2 and arterial stiffness: a systematic review

Population: 7 RCTs

Key finding: MK-7 supplementation (180 mcg/day for 3 years) significantly improved arterial stiffness in postmenopausal women (p<0.05).

RCT, double-blind2019PMID: 31691193

Vitamin K2 and calcium metabolism

Population: 244 postmenopausal women

Key finding: MK-7 (180 mcg/day) significantly increased carboxylated osteocalcin (p<0.001), indicating improved calcium direction to bones.

RCT2020PMID: 32914701

Synergistic effects of vitamin D3 and K2

Population: 63 adults

Key finding: Combined D3+K2 supplementation improved bone mineral density more than D3 alone (p=0.04), supporting synergistic mechanisms.

RCT crossover2021PMID: 33865176

MK-7 vs MK-4 bioavailability comparison

Population: 42 healthy adults

Key finding: MK-7 (100 mcg) provided sustained K2 activity over 72 hours, while MK-4 (1,500 mcg) peaked rapidly but cleared within 8 hours.

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 calcium metabolism and bone mineralization”

Category: Bone Health · Confidence: 9/10

“Supports cardiovascular health by helping direct calcium away from arteries”

Category: Cardiovascular · Confidence: 8/10

“Works synergistically with vitamin D3 for skeletal health”

Category: Bone Health · Confidence: 8/10

Get the full substantiation report for Vitamin K2

Includes all 32+ 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

Magnesium

89 studies · Sleep & Relaxation

Calcium

134 studies · Bone Health

Key Terms

Randomised Controlled Trial (RCT)Bioavailability Clinically Effective Dose

Frequently Asked Questions

Is vitamin K2 FDA approved?

Vitamin K2 is sold as a dietary supplement. The FDA has established a combined Daily Value for vitamin K (120 mcg) but does not distinguish between K1 and K2. K2 supplements do not require FDA approval.

What is the difference between MK-4 and MK-7?

MK-4 has a short half-life (hours) and requires high doses (15–45 mg). MK-7 has a 3-day half-life, requiring only 100–200 mcg daily. MK-7 is preferred for cardiovascular and bone supplementation due to sustained activity.

What dosage of K2 is used in clinical studies?

MK-7 studies typically use 100–200 mcg/day. MK-4 studies use 15–45 mg/day (much higher due to rapid clearance). Take with a fat-containing meal for optimal absorption.

Stop Spending Weeks on Substantiation

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