The evidence ledger / 2026-09-13
A claim should
show its work.
The finding. The setting.
The line we do not cross.
This is a selected, maintained reading of evidence and design boundaries, not a systematic review or a certification of clinical readiness. Study findings and Fasolati design rules are labeled separately.
Read the setting before the conclusion.
Mechanism entries retain their cells, animals or tissue setting. Human treatment results retain their population and intervention. Measurement proposals and design boundaries are not efficacy evidence.
“Checked” is an editorial source-check date, not a clinical approval, a systematic-review search cutoff or a guarantee that no newer evidence exists. Proposed changes need a named human reviewer before public release.
Inspect the claims
11 of 11 claims
No matching claims. Clear the filters or use a broader term.
Wild-type and gingipain-deficient OMV comparisons supported a gingipain contribution to endothelial-barrier disruption, with PECAM-1 loss associated with the response. The zebrafish experiments used direct systemic injection, not oral exposure.
Published support: Farrugia et al., 2020
This does not calibrate an oral-rinse measurement to vascular leak, heart attack, or stroke risk in a person.
What would justify the next step?
A candidate barrier-response benchmark, with preparation, cargo, and exposure controls.
Seyama and colleagues reported liver translocation and reduced insulin-responsive hepatic glycogen synthesis in mice. In HepG2 cells, OMVs attenuated insulin-stimulated Akt/GSK-3β signaling in a gingipain-dependent manner.
Published support: Seyama et al., 2020
This is not proof that a person’s glucose excursions are caused by oral vesicles, and it does not establish the same effect in muscle or adipose tissue.
What would justify the next step?
A focused metabolic mechanism to test at exposure levels relevant to the intended human question.
Aged male mice given OMVs by oral gavage at 4 mg/kg every other day for eight weeks showed neuroinflammatory, tau-phosphorylation, and memory-task effects.
Published support: Gong et al., 2022
The experimental dose is not established as ordinary human exposure. This is not evidence for a personal Alzheimer’s risk meter or proof of human disease causation.
What would justify the next step?
Retain the animal finding with its dose and route, rather than collapsing it into a mouth-to-brain prediction.
Vesicles from different periodontal organisms produced different TLR2 and TLR4 response profiles under the tested conditions.
Published support: Cecil et al., 2016
A receptor response does not identify every active ligand. Comparing species individually does not establish synergy when their vesicles are combined.
What would justify the next step?
A panel of functional readouts with ligand-attribution and interference controls, not one universal inflammation score.
RNA-associated inflammatory effects were studied in U937 macrophage-like cells. The mouse brain-delivery experiment used intracardiac administration, bypassing the oral barrier.
Published support: Han et al., 2019
Delivery by injection does not establish natural oral escape, human brain transit, or Alzheimer’s causation.
What would justify the next step?
Separate cargo biology from transport biology, and require the relevant route to be tested.
In five paired colorectal-cancer and adjacent-normal tissue samples, Zheng and colleagues found greater FomA signal in tumor-derived EV-enriched fractions, interpreted as F. nucleatum EV enrichment. Separate cell and mouse experiments supported FomA-transfer effects on adhesion, colonization, and tumor progression.
Published support: Zheng et al., 2024 · Marker-specificity context
FomA is not a vesicle-exclusive marker. Human tissue enrichment and model mechanisms are separate observations; they do not establish oral origin in an individual or validate an oral-rinse cancer predictor.
What would justify the next step?
A specific tissue-interaction hypothesis. Do not substitute whole-bacterium FadA studies for vesicle-specific FomA evidence.
Human evidence · Clinical systematic review
Periodontal treatment and glycemic control
In people with diabetes and periodontitis, the Cochrane review found HbA1c 0.43 percentage points lower at three to four months with periodontal treatment versus no active treatment or usual care (95% CI: 0.28 to 0.59 points lower; moderate-certainty evidence).
Published support: Simpson et al., Cochrane, 2022
This concerns periodontal treatment in a defined population. It does not identify OMVs as the mediator or demonstrate Fasolati or Loria efficacy.
What would justify the next step?
Keep population, comparator, time point, uncertainty and intervention attached to the result.
Human evidence · Clinical systematic review
Periodontal treatment and systemic inflammation
Luthra and colleagues reported lower C-reactive protein at six months after periodontal treatment, with heterogeneous results. The smaller analysis at twelve months or longer did not detect an effect, with limited longer-term evidence.
Published support: Luthra et al., 2023
A change in CRP is not proof of oral-vesicle mediation, a universal sustained effect, or benefit from a Fasolati product.
What would justify the next step?
Retain follow-up duration and heterogeneity. Do not replace the original intervention with an oral-care product.
Measurement · Methodological guidance
Identify the material before interpreting activity
The Fasolati research proposal separates bacterial burden, vesicle-associated material, non-vesicular material and functional activity. MISEV2023 is a methodological reference, not validation of a Fasolati assay.
Published support: MISEV2023 guidance
Enrichment is not purity. A detected marker or active fraction alone is not sufficient to establish the identity, origin and activity of intact bacterial vesicles.
What would justify the next step?
Specify collection, separation, identity, contamination, interference and repeatability controls before interpreting a proposed assay.
Design boundary · Fasolati product-design rule
Life Board is a design demonstration
The demonstration uses authored fictional observations to show change, missingness and disagreement across separate oral, gut and host-response channels.
Fasolati design rule, not a published study finding.
It is not a live assay, clinical decision system, validated disease-risk score, patient record or completed clinical study.
What would justify the next step?
Test whether reviewers understand the separation between observation, interpretation and the next question before considering clinical evaluation.
Design boundary · Fasolati editorial rule
Product claims require product-specific support
Finished-product identity, current labeling, formulation and intended use must be verified before product-specific efficacy language or purchase instructions are added to the dossier.
Fasolati design rule, not a published study finding.
An ingredient paper, periodontal-treatment trial or OMV mechanism study cannot be relabeled as a clinical result for Loria. A related brand is not evidence that two products have the same formulation.
What would justify the next step?
Obtain approved product assets and source documents; have the responsible product and scientific reviewers approve the resulting dossier.
An inspectable record
What changed, and why.
These entries summarize wording corrections made in the September 12 quality review and published in the prior release. Before-and-after descriptions below are editorial summaries, not quotations from the papers. This ledger makes those changes easier to inspect.
2026-09-12 Made the exposure route explicit
- Before
- The summary described endothelial-barrier disruption without naming the zebrafish exposure route.
- After
- The summary now states that the zebrafish experiments used direct systemic injection, not oral exposure.
- Why
- Prevent a model-delivery experiment from reading as a demonstrated natural oral-to-systemic route.
2026-09-12 Separated animal and cell findings
- Before
- The summary grouped liver translocation, signaling and glycogen synthesis as effects in experimental systems.
- After
- Mouse liver translocation and glycogen findings are separated from the HepG2 insulin-signaling experiment.
- Why
- Readers should be able to tell which experimental system supports each statement.
2026-09-12 Narrowed the human-tissue statement
- Before
- The summary described EV enrichment in clinical colorectal-cancer tissue.
- After
- The summary specifies five paired samples and greater FomA signal in EV-enriched tumor fractions, with a non-exclusive-marker caveat.
- Why
- Distinguish observed signal, the authors’ interpretation and separate model experiments.
2026-09-12 Restored the clinical comparison and uncertainty
- Before
- The clinical summary gave the average HbA1c reduction, population and time point without the comparator or confidence interval.
- After
- The wording includes no active treatment or usual care as the comparator and the 95% confidence interval.
- Why
- A treatment effect should travel with the comparison and its uncertainty.
2026-09-12 Added follow-up limits to the CRP result
- Before
- The summary described lower CRP with heterogeneity but did not specify the six-month result.
- After
- The summary separates the six-month result from the smaller, limited longer-term analysis.
- Why
- Avoid implying a demonstrated durable effect across follow-up periods.
Follow the record, not a promise.
The evidence updates feed (RSS) provides the dated editorial changes in this snapshot. Copy its address into an RSS reader after this release is published. It is not an email subscription, an automated literature monitor or a promise of a publishing cadence.
Future entries should identify the claim, source, changed wording, reason and human release reviewer. A correction can narrow a claim, not just strengthen it.