Research question
Is PMA-zeolite safe for long-term use?
Method
Physicochemical characterisation, toxicological tests incl. cytotoxicity, sensitisation, irritation, subchronic toxicity, genotoxicity
Result
No cytotoxicity, no sensitisation, safe subchronic use even at multiples of the recommended dose. No mutagenicity. A 2018 review confirms safe long-term use.
Source: Kraljević Pavelić, S. et al.: Critical Review on Zeolite Clinoptilolite Safety and Medical Applications in vivo. Frontiers in Pharmacology 2018, 9:1350.
To the publication (DOI)Research question
Can PMA-zeolite improve intestinal wall integrity and reduce inflammatory markers?
Method
Randomised, double-blind, placebo-controlled study (RCT) with 52 endurance-trained participants over 12 weeks. Measurement of zonulin as a leaky gut marker as well as inflammatory parameters.
Result
Significant reduction in zonulin levels (marker for increased intestinal permeability). Trend towards anti-inflammatory signalling (IL-10). The gut barrier was demonstrably strengthened.
Source: Lamprecht, M. et al.: Effects of zeolite supplementation on parameters of intestinal barrier integrity, inflammation, redoxbiology and performance in aerobically trained subjects. Journal of the International Society of Sports Nutrition 2015, 12:40.
To the publication (DOI)Research question
Does PMA-zeolite selectively bind heavy metals without affecting nutrient status?
Method
Controlled monitoring across three clinical studies (28 days, 12 weeks, 4 years). Measurement of heavy metals and minerals in blood by ICP mass spectrometry.
Result
Contaminants such as nickel, aluminium and arsenic decreased significantly with long-term or medium-term intake. Mineral status remained essentially stable — the ion exchange works in a targeted manner.
Source: Kraljević Pavelić, S. et al.: Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients. Frontiers in Medicine 2022, 9:851782.
To the publication (DOI)Research question
Is aluminium released from the zeolite crystal lattice on ingestion?
Method
Measurement of blood aluminium levels during daily intake over 12 weeks as well as ICP-MS monitoring in three further clinical studies (up to 4 years).
Result
No increase in blood aluminium — neither 1 hour after intake nor after 12 weeks of use. With long-term intake, aluminium levels even decreased significantly. The stable SiO₄/AlO₄ lattice does not release aluminium.
Sources: Lamprecht, M. et al., Journal of the International Society of Sports Nutrition 2015, 12:40 · Kraljević Pavelić, S. et al., Frontiers in Medicine 2022, 9:851782.
Research question
Can PMA-zeolite favourably influence inflammation-associated markers in irritable bowel syndrome and alleviate symptoms?
Method
Randomised, double-blind, controlled pilot study with 41 IBS patients. 3 g PMA-zeolite twice daily or placebo. Recording of inflammatory markers and the gut microbiome.
Result
Inflammation-associated markers improved in the zeolite group. Immunomodulatory bacteria (bifidobacteria, lactobacilli) increased — indicating an anti-inflammatory effect and strengthening of the mucus layer.
Source: Petkov, V. et al.: PMA-zeolite can modulate inflammation associated markers in irritable bowel disease — an explorative randomized, double blinded, controlled pilot trial. Neuro Endocrinology Letters 2021, 42(1):1–12.
To the publication (PubMed)Research question
Are the pilot data confirmed under real-world conditions?
Method
Non-interventional study (NIS) with 204 IBS patients over 8 weeks under real-world conditions. Recording of quality of life (SF-36), symptoms (Rome III) and stool consistency (Bristol scale).
Result
Seven out of eight quality-of-life subscales improved significantly, with abdominal pain and bloating days particularly pronounced. Patients with diarrhoea-predominant type (IBS-D) benefited most. The treatment was well tolerated.
Source: Mosgoeller, W. et al.: PMA — Zeolite (Clinoptilolite) in the Management of Irritable Bowel Syndrome — a Non-Interventional Study. Zeitschrift für Gastroenterologie 2024.
To the publication (DOI)Research question
Does PMA-zeolite have positive effects on bone health?
Method
Randomised, double-blind, placebo-controlled study with osteoporosis patients over one year. Measurement of bone mineral density, bone formation markers, pain and quality of life.
Result
Bone mineral density and bone formation markers increased, pain decreased significantly and quality of life improved compared with the placebo group. One year of intake proved to be safe.
Source: Kraljević Pavelić, S. et al.: Treatment of osteoporosis with a modified zeolite shows beneficial effects in an osteoporotic rat model and a human clinical trial. Experimental Biology and Medicine 2021, 246(5):529–537.
To the publication (DOI)Research question
Do the positive bone effects persist in the long term?
Method
5-year evaluation of the randomised, double-blind TOP study with 100 osteoporosis patients. Long-term monitoring of fracture risk, bone metabolism markers and quality of life.
Result
Fracture risk decreased significantly in the zeolite group (p = 0.002). Bone turnover markers (osteocalcin, beta-CrossLaps) indicated a predominance of bone formation. Long-term intake proved safe and well tolerated.
Source: Kraljević Pavelić, S. et al.: Clinical Parameters in Osteoporosis Patients Supplemented With PMA-Zeolite at the End of 5-Year Double-Blinded Clinical Trial. Frontiers in Medicine 2022, 9:870962.
To the publication (DOI)Research question
Can PMA-zeolite reduce side effects of chemotherapy?
Method
Randomised, double-blind, placebo-controlled study (ZeOxaNMulti trial) with 120 patients on oxaliplatin-based chemotherapy. Measurement of treatment adherence, nerve damage (CIPN) and adverse effects.
Result
More patients in the PMA-zeolite group completed the planned chemotherapy cycles (p = 0.03). In men, significantly fewer chemotherapy-induced nerve damage (CIPN) occurred.
Source: Vitale, M.G. et al.: ZeOxaNMulti Trial: A Randomized, Double-Blinded, Placebo-Controlled Trial of Oral PMA-Zeolite to Prevent Chemotherapy-Induced Side Effects, in Particular, Peripheral Neuropathy. Molecules 2020, 25(10):2297.
To the publication (DOI)Research question
Are the chemotherapy results confirmed during follow-up?
Method
30-month follow-up of 104 patients from the original ZeOxaNMulti study. Analysis of survival data and subgroups by sex, tumour type and treatment regimen.
Result
In certain subgroups, sustained benefits in chemotherapy tolerability were observed. The results support use as an adjunctive measure.
Source: Vitale, M.G. et al.: Survival analyses of the ZeOxaNMulti trial: Follow-up randomized, double-blinded, placebo-controlled trial of oral PMA-zeolite to prevent chemotherapy-induced side effects, especially peripheral neuropathy. Frontiers in Pharmacology 2022, 13:874028.
To the publication (DOI)Research question
Does PMA-zeolite affect blood parameters or oxidative stress?
Method
Controlled clinical studies with extensive blood monitoring (minerals, metals, clinical chemistry) as well as assessment of redox parameters during 12 weeks of intake.
Result
Blood values remained unremarkable during intake — there were no indications of liver or kidney strain. The literature also describes antioxidant properties of zeolite clinoptilolite.
Sources: Kraljević Pavelić, S. et al., Frontiers in Medicine 2022, 9:851782 · Lamprecht, M. et al., Journal of the International Society of Sports Nutrition 2015, 12:40.
