Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients

Abstract

The natural clinoptilolite material is an inorganic crystal mineral called zeolite. It has been extensively studied and used in industrial applications and veterinary and human medicine due to positive effects on health. Limited data is available in the scientific literature about its effects on the levels of physiologically relevant minerals in the human organism. Accordingly, we performed a comprehensive and controlled monitoring of the relevant mineral and contaminants levels in human subjects supplemented with a certified clinoptilolite material within three clinical trials with different supplementation regimens. Effects of a registered and certified clinoptilolite material PMA-zeolite on selected mineral and metal levels were determined by standard biochemical methods and inductively coupled plasma mass spectrometry (ICP-MS) in the blood of subjects enrolled in three clinical trials: short-term (28 days, Mineral Metabolism and selected Blood Parameters study MMBP), medium-term (12 weeks, Morbus Crohn study), and long-term (4 years, Osteoporosis TOP study) supplementation. Lower concentrations were observed for copper (Cu) in patients with osteoporosis, which normalized again in the long-term supplementation trial, whereas sodium (Na) and calcium (Ca) levels diminished below the reference values in patients with osteoporosis. In the short- and long-term supplementation trials, increased levels of lead (Pb) were observed in PMA-zeolite-supplemented subjects, which decreased in the continued long-term supplementation trial. Increased levels of aluminum (Al) or Pb attributable to eventual leakage from the material into the bloodstream were not detected 1 h after intake in the short-term supplementation trial. Nickel (Ni) and Al were statistically significantly decreased upon long-term 4-year supplementation within the long-term supplementation trial, and arsenic (As) was statistically significantly decreased upon 12-weeks supplementation in the medium-term trial. Alterations in the measured levels for Na and Ca, as well as for Pb, in the long-term trial are probably attributable to the bone remodeling process. Checking the balance of the minerals Cu, Ca, and Na after 1 year of supplementation might be prescribed for PMA-supplemented patients with osteoporosis.

Clinical trial registration: [https://ichgcp.net/clinical-trials-registry/NCT03901989" title="See in ClinicalTrials.gov">NCT03901989, NCT05178719, NCT04370535, NCT04607018].

Keywords: PMA-zeolite; clinical study; clinoptilolite; metals; minerals; safety.

Conflict of interest statement

SK and KP were independent scientific advisors of Panaceo International GmbH, Austria. SE was employed at Panaceo International. GmbH, Austria, and involved in technical support to PMA-zeolite medical device documentation and clinical trials randomization. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Kraljević Pavelić, Saftić Martinović, Simović Medica, Žuvić, Perdija, Krpan, Eisenwagen, Orct and Pavelić.

Figures

FIGURE 1

Levels of contaminants in Placebo and Verum groups during the osteoporosis TOP study course of 4 years with corresponding reference limits. (A) Concentrations of mercury, cadmium, arsenic, nickel, and aluminum. Statistically lower values were observed in TOP4 in comparison with TOP3 for nickel (post-hoc analysis, p < 0.001). (B) Concentrations of lead in the osteoporosis TOP study course of 4 years. Statistically lower levels of lead were observed in TOP4 comparison with TOP3 (post-hoc analysis, p < 0.001). TOP1-Placebo (without PMA-zeolite supplementation); TOP1-Verum, end of the first year of PMA-zeolite supplementation; TOP2-Verum 2Y, end of the second year of PMA-zeolite supplementation; TOP3-Verum 3Y, end of the third year of PMA-zeolite supplementation; TOP4-Verum 4Y, end of the fourth year of PMA-zeolite supplementation.

FIGURE 2

Copper (A), sodium (B), and calcium (C) blood levels in the Placebo and Verum groups during the osteoporosis TOP study course of 4 years with corresponding limits of the referent values. Statistically significant lower levels (post-hoc, p < 0.05) were observed in the third year for copper, sodium and calcium and in the fourth year for calcium and sodium in comparison with the lower referent values. TOP1-Placebo (without PMA-zeolite supplementation); TOP1-Verum, end of the first year of PMA-zeolite supplementation; TOP2-Verum 2Y, end of the second year of PMA-zeolite supplementation; TOP3-Verum 3Y, end of the third year of PMA-zeolite supplementation; TOP4-Verum 4Y, end of the fourth year of PMA-zeolite supplementation.

FIGURE 3

Schematic visualization of the monitoring of minerals’ and contaminants’ levels in the blood of PMA-supplemented subjects and major results listed as statistically relevant changes in particular mineral or contaminant levels (p < 0.05).