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.

Glycine: Clinical Evidence & Substantiation Summary

Clinical Trials

Strongest Evidence

Sleep & Recovery

Typical Dosage

3–5 g/day

Common Forms

Glycine powder

What Is Glycine?

Glycine is the simplest amino acid, serving as a building block for proteins including collagen, a neurotransmitter in the nervous system, and a precursor for glutathione synthesis. It has emerging evidence for sleep quality, metabolic health, and joint support.

Mechanism of action: Glycine acts as an inhibitory neurotransmitter in the CNS, binding to glycine receptors and NMDA receptors. It lowers core body temperature (promoting sleep onset), is a precursor for glutathione (via γ-glutamyl-cysteinyl-glycine), and constitutes one-third of collagen's amino acid composition.

Clinical Evidence Summary

Below are 5 key clinical studies on Glycine. Nutra Comp analyses 19+ studies in its full clinical evidence report.

RCT, double-blind crossover2012PMID: 22293292

Glycine ingestion improves subjective sleep quality

Population: 11 adults with mild sleep complaints

Key finding: 3 g glycine before bed significantly improved subjective sleep quality, reduced daytime sleepiness, and improved next-day cognitive function (p<0.05).

RCT2021PMID: 33992294

Glycine and glutathione synthesis in aging

Population: 24 older adults + 12 young adults

Key finding: Glycine + N-acetylcysteine (GlyNAC) supplementation restored glutathione levels, reduced oxidative stress, and improved mitochondrial function in older adults.

Systematic review2018PMID: 30368550

Glycine supplementation and metabolic health

Population: 7 studies

Key finding: Glycine supplementation improved insulin sensitivity and reduced markers of oxidative stress in metabolic syndrome populations.

Review2019PMID: 31142457

Glycine and collagen synthesis

Population: Clinical and preclinical data

Key finding: Glycine is rate-limiting for collagen synthesis in conditions of high demand (wound healing, exercise recovery). Supplementation increased serum glycine and collagen markers.

Review2018PMID: 29473879

Glycine and neuroprotection

Population: Clinical studies

Key finding: Glycine demonstrated neuroprotective properties through anti-inflammatory and antioxidant mechanisms, with potential applications in neurological health.

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 collagen synthesis and connective tissue health”

Category: Joint Health · Confidence: 7/10

“Supports healthy glutathione levels and antioxidant defence”

Category: Antioxidant · Confidence: 7/10

Get the full substantiation report for Glycine

Includes all 19+ clinical studies analysed, complete claims library, and a ready-to-file substantiation memo.

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Related Ingredients

Magnesium

89 studies · Sleep & Relaxation

Collagen Peptides

41 studies · Skin Health

NAC (N-Acetyl Cysteine)

53 studies · Antioxidant & Detoxification

Key Terms

Randomised Controlled Trial (RCT)Bioavailability Clinically Effective Dose

Frequently Asked Questions

Is glycine FDA approved?

Glycine is sold as a dietary supplement and has GRAS status as a food ingredient. It does not require FDA drug approval.

What are the most studied benefits?

Sleep quality improvement (via core temperature reduction), glutathione support (especially when combined with NAC), and collagen synthesis support.

What dosage is used?

3 g before bed for sleep support. 3–5 g/day for general supplementation. As part of GlyNAC protocol: 1.33 mmol/kg/day (typically ~3–5 g).

Stop Spending Weeks on Substantiation

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