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Concomitant oral intake of purified clinoptilolite tuff (G-PUR) reduces enteral lead uptake in healthy humans.

ABSTRACT: Lead exposure can cause substantial organ damage. Enteral lead absorption may be reduced by concomitant intake of clinoptilolite tuff, a zeolite from natural sources. This study aimed to assess the effect of purified clinoptilolite tuff (G-PUR) on enteral lead uptake in adults using stable lead isotope ²⁰⁴Pb as a tracer. In this randomized, placebo-controlled, double-blind, parallel-group study, 42 healthy participants were randomized to receive oral G-PUR 2.0 g, 2 * 2.0 g, or placebo, together with 2.5 µg of ²⁰⁴Pb in water. The enrichment of ²⁰⁴Pb caused by the tracer in blood and urine was measured by mass spectrometry. G-PUR was well tolerated. The mean maximum ²⁰⁴Pb enrichment of 0.505% of total blood lead was significantly higher (p < 0.0001) in the placebo group compared to G-PUR 2.0 g (0.073%) or G-PUR 2 * 2.0 g (0.057%) group. Normalized ²⁰⁴Pb AUC_0-192 was 86.5, 11.9, and 8.5% * h without and with G-PUR 2.0 g, and G-PUR 2 * 2.0 g, respectively (p < 0.0001 vs. placebo). This smaller ²⁰⁴Pb exposure was paralleled by a reduced urinary excretion in subjects receiving G-PUR. Concomitant oral intake of purified clinoptilolite tuff reduced enteral uptake of ²⁰⁴Pb in healthy humans by approximately 90%. The reduced bioavailability is demonstrable by a decrease of ²⁰⁴Pb tracer enrichment in blood and urine.Trial registration: clinicaltrials.gov identifier: NCT04138693, registered 24/10/2019.

SUBMITTER: Samekova K

PROVIDER: S-EPMC8292361 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Concomitant oral intake of purified clinoptilolite tuff (G-PUR) reduces enteral lead uptake in healthy humans.

Samekova Karolina K Firbas Christa C Irrgeher Johanna J Opper Christine C Prohaska Thomas T Retzmann Anika A Tschegg Cornelius C Meisslitzer Claudia C Tchaikovsky Anastassiya A Gouya Ghazaleh G Freissmuth Michael M Wolzt Michael M

Scientific reports 20210720 1

Lead exposure can cause substantial organ damage. Enteral lead absorption may be reduced by concomitant intake of clinoptilolite tuff, a zeolite from natural sources. This study aimed to assess the effect of purified clinoptilolite tuff (G-PUR) on enteral lead uptake in adults using stable lead isotope <sup>204</sup>Pb as a tracer. In this randomized, placebo-controlled, double-blind, parallel-group study, 42 healthy participants were randomized to receive oral G-PUR 2.0 g, 2 * 2.0 g, or placebo ...[more]

PMID: 34285282

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Project description:BackgroundIrritable bowel syndrome (IBS) is a highly prevalent gastrointestinal disorder with poor response to treatment. IBS with predominant diarrhea (IBS-D) is accompanied by abdominal pain as well as high stool frequency and urgency. Purified clinoptilolite-tuff (PCT), which is approved by the Food and Drug Administration for use as a dietary supplement with the brand name G-PUR®, has previously shown therapeutic potential in other indications based on its physical adsorption capacity.AimTo assess whether symptoms of IBS-D can be ameliorated by oral treatment with PCT.MethodsIn this randomized, placebo-controlled, double-blind pilot study, 30 patients with IBS-D diagnosis based on Rome IV criteria were enrolled. Following a 4-wk run-in phase, 14 patients were randomized to receive a 12-wk treatment with G-PUR® (2 g three times daily), and 16 patients received placebo. The relief from IBS-D symptoms as measured by the proportion of responders according to the Subject's Global Assessment (SGA) of Relief was assessed as the primary outcome. For the secondary outcomes, validated IBS-D associated symptom questionnaires, exploratory biomarkers and microbiome data were collected.ResultsThe proportions of SGA of Relief responders after 12 wk were comparable in both groups, namely 21% in the G-PUR® group and 25% in the placebo group. After 4 wk of treatment, 36% of patients in the G-PUR® group vs 0% in the placebo group reported complete or considerable relief. An improvement in daily abdominal pain was noted in 94% vs 83% (P = 0.0353), and the median number of days with diarrhea per week decreased by 2.4 d vs 0.3 d in the G-PUR® and placebo groups, respectively. Positive trends were observed for 50% of responders in the Bristol Stool Form Scale. Positive trends were also noted for combined abdominal pain and stool consistency response and the Perceived Stress Questionnaire score. Only 64% in the G-PUR® group compared to 86% in the placebo group required rescue medication intake during the study. Stool microbiome studies showed a minor increase in diversity in the G-PUR® group but not in the placebo group. No PCT-related serious adverse events were reported.ConclusionIn this randomized, double-blind, placebo-controlled study, the PCT product, G-PUR®, demonstrated safety and clinical benefit towards some symptoms of IBS-D, representing a promising novel treatment option for these patients.

Project description:The aim of the experiment is to study the pattern of genes expression involved in defense to heavy metals and their transport and distribution within plant organs. Most of the plant species inhibits heavy metals entrance to the roots and their transport and accumulation to/in above ground organs after toxic ions penetrate roots. Some species of Brassicacea differ in the pattern of defense gene expression in the roots in a way that allow for greater transport of toxic ions to the above ground part. If so, by harvesting such plants toxic elements will be extracted from the soil. Identification of these differences in the gene expression is crucial in development of the newly emerging environmental biotechnology phytoremediation in which plants as well as being green lungs play also a role of a green liver. Results of our studies with mustard plants showed among others that exposure for 12 hr to 12.5mg of Pb/1L of hydroponics solution is efficient to increase of constitutive genes expression and in de novo induction of genes expression coding for Pb tolerance and that this response is organ specific. Sequencing of the whole genome of A. thaliana opens the opportunity to study this phenomenon at molecular level more widely including the signaling (two-component system) and plasmolemma and tonoplast transporters genes. Therefore in our further steps we are going to use Arabidopsis as a model plant and the transcriptomics aproach is the only way for such studies. At first based on results with mustard physiological study we will conduct for elucidating Arabidopsis plant responses to lead in order to choose the most appropriate dose and time of treatment. In the trascriptome experiment we would like to study the profile gene expression in above ground parts and in the roots of arabidopsis plants in response to toxic ions of lead. Results of this study, besides promising applicable aspects, will also lead to a better understanding of plant acclimation and adaptation to antropogenic stresses. We expect to obtain mutant(s) tolerant to Pb and if so, they will be provided to NASC. Experiment Overall Design: 6 samples

Dataset Information

Concomitant oral intake of purified clinoptilolite tuff (G-PUR) reduces enteral lead uptake in healthy humans.

Publications

Concomitant oral intake of purified clinoptilolite tuff (G-PUR) reduces enteral lead uptake in healthy humans.

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