NICEVIVA
MONOGRAPH SPEC LATEST 2022

Slippery Elm (GI Coating)

DIGESTIVE · Evidence Monograph

Slippery Elm (GI Coating) is an evidence-graded digestive monograph evaluated across 8 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 5 randomized controlled trials, encompassing n = 110 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 8 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 5 RCTs (4 Double-Blind)
Cumulative Participants n = 110
Reported Trial Dosages 500 mg · 1,350 mg · 500 mg/day
Trial Duration Range 12 weeks · 4 weeks · 3 months
Reading Time ~4 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 8 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (500 mg · 1,350 mg · 500 mg/day) over a structured 12 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary digestive clinical efficacy (8 PubMed studies)
Quantitative biomarker & outcome analysis (3 studies with effect-size/sample data)
Randomized controlled trial verification (5 RCTs · 4 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 0 reviews)
01

What Is Slippery Elm (GI Coating) & Why Does Form Matter?

Slippery Elm (GI Coating) is classified under DIGESTIVE and has been investigated across 8 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (500 mg, 1,350 mg, 500 mg/day).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Slippery Elm (GI Coating) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (5 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Slippery Elm (GI Coating) acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Slippery Elm (GI Coating) an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 8 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 5 randomized controlled trials (4 double-blind, n = 110 total participants).

Representative peer-reviewed findings include: • PMID:28829393 (2017) — "Effect of Mg on the Microstructure and Corrosion Resistance of the Continuously Hot-Dip Galvanizing Zn-Mg Coating." (Compared to GI coating, the time of the first red rust appears increases by more than two-fold and expansion rate of red rust reduces by more than four-fold in terms of salt spray experiment.) • PMID:36388925 (2022) — "Potential lipid-lowering effects of Ulmus macrocarpa Hance extract in adults with untreated high low-density lipoprotein cholesterol concentrations: A randomized double-blind placebo-controlled trial." (DISCUSSION: UME causes a significant improvement in lipid profiles in adults with untreated high LDL-C concentrations.) • PMID:29958034 (2019) — "A Purported Detoxification Supplement Does Not Improve Body Composition, Waist Circumference, Blood Markers, or Gastrointestinal Symptoms in Healthy Adult Females." (Numerous popular "detoxification" supplements claim to promote the removal of harmful compounds from the body, thereby alleviating gastrointestinal symptoms, improving body composition, and enhancing overall health.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 500 mg · 1,350 mg · 500 mg/day over 12 weeks · 4 weeks · 3 months · 1 weeks. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Slippery Elm (GI Coating), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (500 mg · 1,350 mg · 500 mg/day) and re-evaluate efficacy after 12 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (8 Studies) · 3 Quantitative Analyses

01
CLINICAL STUDY Materials (Basel, Switzerland) (2017) PMID: 28829393 ↗
Effect of Mg on the Microstructure and Corrosion Resistance of the Continuously Hot-Dip Galvanizing Zn-Mg Coating.
Clinical Trial Synthesis 2017 Clinical Study published in Materials (Basel, Switzerland). Key conclusion: Compared to GI coating, the time of the first red rust appears increases by more than two-fold and expansion rate of red rust reduces by more than four-fold in terms of salt spray experiment.
View Original PubMed Abstract ↓

The microstructure of continuously hot-dip galvanizing Zn-Mg coating was investigated in order to obtain the mechanism of the effects of Mg on the corrosion resistance. In this paper, the vertical section of the Zn-0.20 wt % Al-Mg ternary phase diagram near the Al-low corner was calculated. The results indicates that the phase composition of the Zn-0.20 wt % Al-Mg ternary phase diagram near the Al-low corner is the same as Zn-Mg binary phase diagram, suggesting Al in the Zn-Mg (ZM) coatings mainly concentrates on the interfacial layer between the coating and steel substrate. The microstructure of continuously hot-dip galvanizing ZM coatings with 0.20 wt % Al containing 1.0-3.0 wt % Mg was investigated using tunneling electron microscopy (TEM). The morphology of Zn in the coating changes from bulk to strip and finally to mesh-like, and the MgZn₂ changes from rod-like to mesh-like with the Mg content increasing. Al in the ZM coatings mainly segregates at the Fe₂Al₅ inhibition layer and the Mg added to the Zn bath makes this inhibition layer thinner and uneven. Compared to GI coating, the time of the first red rust appears increases by more than two-fold and expansion rate of red rust reduces by more than four-fold in terms of salt spray experiment. The ZM coating containing 2.0 wt % Mg has the best corrosion resistance. The enhanced corrosion resistance of ZM coatings mainly depends on different corrosion products.

02
RANDOMIZED TRIAL (RCT) Frontiers in medicine (2022) PMID: 36388925 ↗
Potential lipid-lowering effects of Ulmus macrocarpa Hance extract in adults with untreated high low-density lipoprotein cholesterol concentrations: A randomized double-blind placebo-controlled trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Frontiers in medicine involving n = 80 participants; statistical significance reported at p = 0.001. Key conclusion: DISCUSSION: UME causes a significant improvement in lipid profiles in adults with untreated high LDL-C concentrations.
View Original PubMed Abstract ↓

INTRODUCTION: Ulmus macrocarpa Hance extract (UME) has demonstrated an antilipidemic effect via upregulation of the adenosine monophosphate-activated protein kinase pathway and regulation of lipid metabolism in both laboratory and animal studies. Therefore, we examined the effects and safety of UME on plasma lipids in adults with untreated high, low-density lipoprotein cholesterol (LDL-C) concentrations. MATERIALS AND METHODS: In the current double-blind placebo-controlled randomized clinical trial, 80 patients with untreated high LDL-C concentrations (130-190 mg/dl) were randomly allocated to either the "UME group" (received 500 mg UME as two capsules per day) or the "Placebo group" (received placebo containing cornstarch as two capsules per day) for 12 weeks. The primary outcome was the change in LDL-C concentration within the 12-week treatment period; secondary outcomes included changes in total cholesterol (TC), triglyceride, high-density lipoprotein cholesterol, apolipoprotein A1, and apolipoprotein B (ApoB) concentrations. RESULTS: UME over 12 weeks led to a greater decrease in LDL-C, TC, and ApoB concentrations than did the placebo as follows: by 18.1 mg/dl (P < 0.001); 23.3 mg/dl (P < 0.001); 9.3 mg/dl (P = 0.018), respectively. When LDL-C, TC, and ApoB concentrations were expressed as a lsmeans percentage of the baseline concentration, they after 12 weeks of UME had greater % differences compared to the placebo as follows: by 11.9% (P < 0.001); 10.0% (P < 0.001); 8.6% (P < 0.05), respectively. However, no significant inter- and intra-group changes in liver enzyme, free fatty acid, anti-inflammatory marker, and fasting glucose concentrations were observed. None of the participants experienced notable adverse events. DISCUSSION: UME causes a significant improvement in lipid profiles in adults with untreated high LDL-C concentrations. CLINICAL TRIAL REGISTRATION: [www.clinicaltrials.gov/], identifier [NCT03773315].

03
CLINICAL STUDY Journal of dietary supplements (2019) PMID: 29958034 ↗
A Purported Detoxification Supplement Does Not Improve Body Composition, Waist Circumference, Blood Markers, or Gastrointestinal Symptoms in Healthy Adult Females.
Clinical Trial Synthesis 2019 Randomized Controlled Trial (RCT) published in Journal of dietary supplements. Key conclusion: Numerous popular "detoxification" supplements claim to promote the removal of harmful compounds from the body, thereby alleviating gastrointestinal symptoms, improving body composition, and enhancing overall health.
View Original PubMed Abstract ↓

Numerous popular "detoxification" supplements claim to promote the removal of harmful compounds from the body, thereby alleviating gastrointestinal symptoms, improving body composition, and enhancing overall health. The present double-blind, randomized, placebo-controlled trial was conducted to examine the effects of a purported detoxification supplement in healthy young adult females. Participants were randomly assigned to consume a multi-ingredient supplement or placebo daily for four weeks. The supplement contained 1,350 mg/serving of a proprietary blend of papaya leaf, cascara sagrada bark, slippery elm bark, peppermint leaf, red raspberry leaf, fenugreek seed, ginger root, and senna leaf. Body composition, waist circumferences, symptoms of gastrointestinal distress, and blood safety markers were evaluated before and after supplementation. Twenty-two participants completed the study, and data were analyzed via two-way mixed ANOVA and t tests. No beneficial or harmful effects of supplementation were found for body composition, waist circumference, gastrointestinal symptoms, or blood markers. These results indicate that consuming a commercially available dietary supplement that purportedly provides detoxification and body composition benefits is apparently safe in healthy young adult females but does not provide any beneficial effects for body composition or gastrointestinal symptoms.

04
CLINICAL STUDY Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences (2022) PMID: 36581572 ↗
Study on molecular biological mechanism of Chinese herbal medicines for the treatment of gastric precancerous lesions based on data mining and network pharmacology.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences. Key conclusion: The results of the network pharmacological analysis showed that the active ingredients were 4 types from Ume plum, 3 from Curcuma longa, 9 from Paeonia lactiflora, 13 from Salvia miltiorrhiza, 7 from Astragalus alba, and 9 from Astragalus; 77 predicted targets were in Ume plum, 1
View Original PubMed Abstract ↓

OBJECTIVE: To explore the molecular biological mechanisms of Chinese herbal medicines for the treatment of gastric precancerous lesions by data mining and network pharmacology. METHODS: The keywords "gastric precancerous lesions""gastric precancerous disease""gastric mucosal intraepithelial neoplasia""gastric mucosal heterogeneous hyperplasia""gastric precancerous state""chronic gastritis, atrophic""combined Chinese and Western medicine""Chinese medicine therapy""efficacy evaluation" "randomized controlled trial"were searched in China Journal Full-text Database, Wanfang Data, VIP database, PubMed and Embase from 2001 to 2021. The information was extracted from the literature which met the inclusion and exclusion criteria, and the database was constructed to identify the high-frequency herbal medicines. The top six Chinese herbal medicines were analyzed by the network pharmacology methods, including the acquisition of herbs compounds and gastric precancerous lesions targets using Pharmacology Database and Analysis Platform and GeneCards databases, construction of protein-protein interaction network, and screening of core targets, Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis of core targets through Metascape platform, etc., to elucidate their active components, targets and pathways. RESULTS: A total of 482 compound prescriptions with 603 herbal medicines were included, and the top 6 herbal medicines with higher application frequency were Ume plum (63.35%), Curcuma longa (58.54%), Paeonia lactiflora (54.06%), Salvia miltiorrhiza (49.92%), Rhizoma alba (46.43%), and Astragalus membranaceus (45.44%). The results of the network pharmacological analysis showed that the active ingredients were 4 types from Ume plum, 3 from Curcuma longa, 9 from Paeonia lactiflora, 13 from Salvia miltiorrhiza, 7 from Astragalus alba, and 9 from Astragalus; 77 predicted targets were in Ume plum, 11 in Curcuma longa, 33 in Paeonia lactiflora, 58 in Salvia miltiorrhiza, 65 in Astragalus alba and 89 in Astragalus; and 98 crossover genes were obtained after these targets were compared with the disease genes, among which HSP90AA1, AKT1, TP53, STAT3,

05
RANDOMIZED TRIAL (RCT) Journal of microbiology (Seoul, Korea) (2021) PMID: 34697783 ↗
Ulmus macrocarpa Hance extract modulates intestinal microbiota in healthy adults: a randomized, placebo-controlled clinical trial.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in Journal of microbiology (Seoul, Korea). Key conclusion: Functional enrichment of bacterial genes showed an increase in primary and secondary bile acid biosynthesis in UME group.
View Original PubMed Abstract ↓

The stem and root bark of Ulmus macrocarpa Hance has been used as traditional pharmacological agent against inflammation related disorders. The objective of this study was to explore the impact of Ulmus macrocarpa Hance extract (UME) on human gut microbiota. A randomized placebo-controlled clinical study was conducted in healthy adults. The study subjects were given 500 mg/day of UME or placebo orally for 4 weeks. Eighty fecal samples were collected at baseline and 4 weeks of UME or placebo intervention. The gut microbiota variation was evaluated by 16S rRNA profiling. The microbial response was highly personalized, and no statistically significant differences was observed in both species richness and abundance. The number of bacterial species identified in study subjects ranged from 86 to 182 species. The analysis for taxonomical changes revealed an increase in Eubacterium ventriosum, Blautia faecis, Ruminococcus gnavus in the UME group. Functional enrichment of bacterial genes showed an increase in primary and secondary bile acid biosynthesis in UME group. Having known from previous studies Eubacterium regulated bile acid homeostasis in protecting gut microbial architecture and immunity, we suggest that UME supplementation might enhance host immunity by modulating gut microbiota. This is the first stage study and forthcoming clinical studies with larger participants are needed to confirm these findings. © 2021. The Microbiological Society of Korea.

06
RANDOMIZED TRIAL (RCT) Minerva obstetrics and gynecology (2022) PMID: 34096694 ↗
Treatment of vulvo-vaginal atrophy with hyaluronate-based gel: a randomized controlled study.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Minerva obstetrics and gynecology. Key conclusion: CONCLUSIONS: A 3-month treatment with Hyalo Gyn gel is effective, safe, and well tolerated for VVA-related symptoms in postmenopausal women.
View Original PubMed Abstract ↓

BACKGROUND: The study aimed to assess the performance and safety of single-use applicators prefilled with hyaluronic acid (HA)-based vaginal gel (Hyalo Gyn) for the treatment of vulvovaginal atrophy (VVA)-related signs and symptoms in postmenopausal women. METHODS: Eighty women were randomized, 46 to Hyalo Gyn gel and 34 to a standard treatment (water-based lubricant). Outcome data collected included: the proportion of subjects having a reduction ≥1 point in the Verbal Rating Scale (VRS) Dryness Score, VRS Global Score, vaginal pH, Vaginal Health Index, Female Sexual Function Index, Female Sexual Distress Scale-Revised, patients' global assessment, tolerability, and safety. RESULTS: Significant improvements were observed for all the assessed endpoints in both treatment groups. The perception of any improvement on the VRS Dryness Score was not statistically different between the treatment groups. A sensitivity analysis on the absolute change in VRS Dryness Score showed a statistically significant difference in favor of the Hyalo Gyn group at 3 months. CONCLUSIONS: A 3-month treatment with Hyalo Gyn gel is effective, safe, and well tolerated for VVA-related symptoms in postmenopausal women.

07
RANDOMIZED TRIAL (RCT) Evidence-based complementary and alternative medicine (2018) PMID: 29681977 ↗
Effects of 4-Week Intervention with Ulmus macrocarpa Hance Extract on Immune Function Biomarkers in Healthy Adults: A Randomized Controlled Trial.
Clinical Trial Synthesis 2018 Randomized Controlled Trial (RCT) published in Evidence-based complementary and alternative medicine; statistical significance reported at p = 0.027. Key conclusion: In conclusion, administration of UME for 1 week increased serum TNF-α and sustains IL-2 in human, which suggests that UME increases Th1-related immune function in the short term in healthy people.
View Original PubMed Abstract ↓

Ulmus macrocarpa extract has been shown to have immune-related effects in animals, but no studies have yet been performed in humans. This randomized, double-blind, placebo-controlled trial was conducted to determine the effect of short-term administration of Ulmus macrocarpa Hance extract (UME) on immune function biomarkers and its safety in human subjects. Fifty-eight subjects were randomly assigned to a UME group or a placebo group. Subjects in the UME group were given 500 mg per day of UME orally for 4 weeks. Mean fluorescence intensity (MFI) of tumor necrotic factor-α increased only in the UME group at 1 week (P = 0.027). The MFI of interleukin-2 decreased less significantly in the UME group than in the placebo group at 1 week (P = 0.028). However, unfortunately, at 4 weeks, no intergroup differences were detected in MFIs of cytokine. In conclusion, administration of UME for 1 week increased serum TNF-α and sustains IL-2 in human, which suggests that UME increases Th1-related immune function in the short term in healthy people. However, additional studies are needed to confirm the results of this first-stage study and further trials are required to decide on optimal dosage and duration of administration. This trial is registered with ClinicalTrials.gov Identifier: NCT02414412.

08
RANDOMIZED TRIAL (RCT) Journal of acupuncture and meridian studies (2010) PMID: 20633511 ↗
Efficacy of pharmacopuncture using root bark of Ulmus davidiana Planch in patients with knee osteoarthritis: a double-blind randomized controlled trial.
Clinical Trial Synthesis 2010 Randomized Controlled Trial (RCT) published in Journal of acupuncture and meridian studies involving n = 30 participants. Key conclusion: However, the two interventions were not significantly different as measured by the Western Ontario and McMaster Universities pain score and total pain scores, 36-Item Short Form Health Survey, and Korean Health Assessment Questionnaire.
View Original PubMed Abstract ↓

The aim of this study was to determine whether pharmacopuncture is a clinically effective and safe method for the treatment of knee osteoarthritis. Patients were recruited between August 2008 and December 2008 at the Ilsan Hospital associated with Dongguk University. Patients were randomly assigned to one of the two groups. The experimental group (n = 30) received pharmacopuncture using root bark of Ulmus davidiana Planch (UDP) twice a week for 6 weeks; the control group (n = 30) received normal saline injections. Fifty-three patients completed the trial. After the seventh treatment, we found that UDP pharmacopuncture was more effective in pain improvement using a Visual Analog Scale than was normal saline injection. However, the two interventions were not significantly different as measured by the Western Ontario and McMaster Universities pain score and total pain scores, 36-Item Short Form Health Survey, and Korean Health Assessment Questionnaire. No subject showed any serious adverse effects. The effects of pharmacopuncture treatment were a combination of placebo, needle stimulation, mechanical effect of the solution, and a chemical effect of UDP. However, normal saline used as the control intervention displayed the first three effects, and thus its effect was not inert. This may have influenced the results of the trial, which was statistically insignificant between the two groups, except following the seventh treatment session. Copyright (c) 2010 Korean Pharmacopuncture Institute. Published by .. All rights reserved.

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