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.

Aged Garlic Extract: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Cardiovascular Health

Typical Dosage

600–2,400 mg/day (aged extract)

Common Forms

Kyolic® aged garlic extract

What Is Aged Garlic Extract?

Aged garlic extract (AGE) is produced by ageing raw garlic in ethanol for 20+ months, producing unique organosulfur compounds including S-allylcysteine (SAC). Clinical evidence strongly supports its cardiovascular benefits.

Mechanism of action: SAC and other AGE compounds inhibit cholesterol synthesis (HMG-CoA reductase), reduce platelet aggregation, improve endothelial function via eNOS activation, and lower blood pressure through ACE inhibition and hydrogen sulfide production.

Clinical Evidence Summary

Below are 3 key clinical studies on Aged Garlic Extract. Nutra Comp analyses 48+ studies in its full clinical evidence report.

Meta-analysis2016PMID: 27139575

Garlic supplementation and blood pressure: updated meta-analysis

Population: 20 RCTs, 970 participants

Key finding: Garlic supplementation reduced SBP by 8.3 mmHg (p<0.001) and DBP by 5.5 mmHg (p<0.001) in hypertensive individuals.

Meta-analysis2020PMID: 32268543

Aged garlic extract and lipid profile

Population: 12 RCTs

Key finding: AGE reduced total cholesterol by 17 mg/dL (p=0.001) and LDL cholesterol by 9 mg/dL (p=0.01) after ≥12 weeks.

RCT2018PMID: 30466985

Garlic and coronary artery calcification

Population: 45 adults

Key finding: AGE (2,400 mg/day) significantly slowed progression of coronary artery calcification by 48% versus placebo over 12 months (p=0.01).

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 cardiovascular function”

Category: Cardiovascular · Confidence: 9/10

“Supports healthy blood pressure already within the normal range”

Category: Blood Pressure · Confidence: 8/10

“Supports healthy cholesterol levels already within the normal range”

Category: Cholesterol · Confidence: 7/10

Get the full substantiation report for Aged Garlic Extract

Includes all 48+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

Join Waitlist for Full Access

Related Ingredients

Omega-3 Fatty Acids

214 studies · Cardiovascular Health

Berberine

47 studies · Blood Sugar Support

Coenzyme Q10 (CoQ10)

68 studies · Cardiovascular Health

Key Terms

Randomised Controlled Trial (RCT)Meta-Analysis Clinically Effective Dose

Frequently Asked Questions

Is garlic extract FDA approved?

Garlic extract is a dietary supplement under DSHEA. Kyolic® aged garlic extract is the most clinically studied form.

What's the difference between aged and fresh garlic?

Ageing converts harsh, unstable allicin into stable, odourless SAC compounds. Aged garlic extract has more consistent bioactivity and fewer GI side effects.

What dosage is used in clinical studies?

Most studies use 600–2,400 mg/day of aged garlic extract. The blood pressure meta-analysis found effects at ≥600 mg/day.

Stop Spending Weeks on Substantiation

Nutra Comp generates full clinical evidence reports, FDA-compliant structure–function claims, and substantiation memos in minutes — not months.

Join the Waitlist