Zeolite studies: the clinical data for PMA-Zeolith®
Studied in humans
Eleven clinical studies with research question, method, result and source – transparent and fully linked.
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11
Clinical Examinations
5
Randomised and double-blind
5
Years
20 +
Years of research
Overview of all examinations
Study type, scope and key finding at a glance. The detailed presentation with source reference can be found below.
| Examination | Type | Scope | Key result |
|---|---|---|---|
| Safety and Toxicology Kraljećvić Pavelić et al. 2018 | Review | Data up to 2018 | No cytotoxicity, no mutagenicity, safe long-term use |
| Intestinal barrier in athletes Lamprecht et al. 2015 | RCT, double-blind | 52 people, 12 weeks | Zonulin significantly reduced, trend in IL-10 |
| Blood parameters and bonding Kraljećvić Pavelić et al. 2022 | Clinical Monitoring | 3 studies, up to 4 years | Nickel, aluminium and arsenic have decreased, minerals are stable |
| Irritable bowel syndrome, pilot study Petkov et al. 2021 | RCT, double-blind | 41 people | Inflammation-associated markers improved, bifidobacteria increased |
| Irritable bowel syndrome, everyday data Mosgoeller et al. 2024 | Non-interventional | 204 people, 8 weeks | 7 out of 8 quality-of-life subscales significantly improved |
| Osteoporosis Kraljećvić Pavelić et al. 2021 | RCT, double-blind | 1 year | Bone density and bone formation markers increased, pain decreased |
| Osteoporosis, follow-up Kraljećvić Pavelić et al. 2022 | Follow-up | 100 people, 5 years | Fracture risk significantly decreased (p = 0.002) |
| Chemotherapy support Vitale et al. 2020 | RCT, double-blind | 120 people | Higher treatment adherence (p = 0.03), less CIPN in men |
| Chemotherapy, follow-up Vitale et al. 2022 | Follow-up | 104 people, 30 months | Sustained tolerability benefits in subgroups |
Safety and tolerability
The question that must be answered first when it comes to a mineral for daily intake: What happens with long-term use?
Safety and Toxicology
Research question: Is clinoptilolite safe for long-term use?
Method: Critical overview of physicochemical characterisation and toxicological testing – cytotoxicity, sensitisation, irritation, subchronic toxicity, genotoxicity.
Result: No cytotoxicity, no sensitisation, no mutagenicity. Even intake at several times the recommended dose was unremarkable in subchronic testing.
Kraljećvić Pavelić, S. et al.: Critical Review on Zeolite Clinoptilolite Safety and Medical Applications in vivo. Frontiers in Pharmacology 2018, 9:1350.
No aluminium from the crystal lattice
Research question: Is aluminium released from the lattice?
Method: Measurement of blood aluminium levels during a twelve-week period of daily intake, as well as ICP-MS monitoring in further clinical studies for up to four years.
Result: No increase in the blood – neither one hour after intake nor after twelve weeks. During long-term intake, levels decreased significantly.
Lamprecht, M. et al., Journal of the International Society of Sports Nutrition 2015, 12:40 · Kraljećvić Pavelić, S. et al., Frontiers in Medicine 2022, 9:851782.
Intestinal barrier and binding in the digestive tract
The field to which the intended purpose of PANACEO medical devices relates. According to the instructions for use, it has been scientifically demonstrated that PMA-Zeolith® has a significant positive effect on intestinal wall integrity – as measured by a reduced concentration of the tight junction modulator zonulin and the inflammatory marker alpha-1-antitrypsin.
Zonulin as a marker of intestinal permeability
Research question: Can the permeability of the intestinal wall be influenced?
Method: Randomised, double-blind, placebo-controlled study with 52 endurance-trained participants over 12 weeks. Faecal zonulin and inflammatory markers were measured.
Result: The zonulin level decreased significantly. For IL-10, there was a trend towards anti-inflammatory signalling.
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.
Selective binding, stable minerals
Research question: Are heavy metals bound without altering the mineral status?
Method: Evaluation of three clinical studies lasting 28 days, 12 weeks and 4 years. Measurement of heavy metals and minerals in blood using ICP mass spectrometry.
Results: Nickel, aluminium and arsenic decreased significantly. Mineral status remained essentially stable – ion exchange acts selectively. The package leaflet lists the bound heavy metals as lead, cadmium, arsenic, chromium and nickel, as well as ammonium.
Kraljećvić 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.
Irritable bowel
Irritable bowel syndrome falls within the intended use of MED DARM REPAIR and SPORT PURE. Two studies with different approaches are available on this: a controlled pilot study and a survey under real-world conditions.
Inflammatory markers and microbiome
Research question: Can inflammation-associated markers in irritable bowel syndrome be influenced?
Method: Randomised, double-blind, controlled pilot study with 41 patients with irritable bowel syndrome. 3 g PMA-Zeolith® or placebo twice daily. Inflammatory markers and the composition of the gut microbiome were assessed.
Result: The markers improved in the zeolite group. Bifidobacteria and lactobacilli increased.
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.
Quality of life under everyday conditions
Research question: Are the pilot data confirmed outside a study setting?
Methods: Non-interventional study with 204 patients with irritable bowel syndrome (IBS) over 8 weeks. Assessed were quality of life (SF-36), symptoms (ROM-III) and stool consistency (Bristol scale).
Results: Seven of eight quality-of-life subscales improved significantly, most notably abdominal pain and days with bloating. The diarrhoea-predominant subtype (IBS-D) responded particularly well.
Mosgoeller, W. et al.: PMA-Zeolite (Clinoptilolite) in the Management of Irritable Bowel Syndrome – a Non-Interventional Study. Zeitschrift für Gastroenterologie 2024.
Tolerability of medical treatments
The intended purpose of MED THERAPY PRO relates to the tolerability of medical treatments. Two randomised studies have evaluated this during chemotherapy.
Support during chemotherapy
Method: Randomised, double-blind, placebo-controlled study (ZeOxaNMulti) with 120 patients undergoing oxaliplatin-based chemotherapy. Data collected included treatment adherence, nerve damage (CIPN) and side effects.
Result: More patients completed the planned cycles (p = 0.03). In men, significantly fewer cases of nerve damage occurred.
Vitale, M.G. et al.: ZeOxaNMulti Trial. Molecules 2020, 25(10):2297.
Follow-up over 30 months
Method: Follow-up of 104 patients in the ZeOxaNMulti study for 30 months. Survival data and subgroups defined by sex, tumour type and treatment regimen were analysed.
Result: In certain subgroups, sustained advantages in the tolerability of chemotherapy were observed.
Vitale, M.G. et al.: Survival analyses of the ZeOxaNMulti trial. Frontiers in Pharmacology 2022, 13:874028.
Further research: bone health
Clinoptilolite has also been investigated outside the gastrointestinal tract. These findings form part of the current state of research and are not covered by any intended purpose.
Bone density in osteoporosis
Method: Randomised, double-blind, placebo-controlled study with patients with osteoporosis over one year. Bone density, bone formation markers, pain and quality of life were measured.
Results: Bone density and bone formation markers increased, pain decreased significantly. Intake over one year was safe.
Kraljećvić Pavelić, S. et al.: Treatment of osteoporosis with a modified zeolite. Experimental Biology and Medicine 2021, 246(5):529–537.
Osteoporosis after five years
Method: Five-year analysis of the randomised, double-blind TOP study with 100 patients. Fracture risk, bone turnover markers and quality of life were observed.
Result: Fracture risk decreased significantly in the zeolite group (p = 0.002). The markers showed a predominance of bone formation.
Kraljećvić 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.
How studies can be categorised
Not every study carries the same weight. Anyone who wants to assess the evidence base for a mineral needs to make three distinctions.
Controlled or observational
In a randomised, double-blind study, chance determines who receives the product, and neither the participants nor the investigators know. Only then can an effect be attributed to the product. A non-interventional study, by contrast, reflects everyday life – it shows what happens under real-world conditions, but cannot establish causation.
In humans or in models
Results from cell culture or animal models are indicative; they are not directly transferable to humans. The studies listed on this page were conducted in humans, unless otherwise stated.
Which raw material
Zeolite is a group of minerals with over 40 members, and even within clinoptilolite, deposits and processing methods differ. The results mentioned here were achieved with PMA-Zeolith® and apply to this raw material.
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What the studies show
Intestinal barrier
The marker Zonulin decreased significantly in a randomised, double-blind study.
Selective binding
Heavy metals decreased in the blood, mineral status remained essentially stable.
Long-term safety
No increase in aluminium, no evidence of strain on the liver or kidneys.
Irritable bowel
Inflammation-associated markers and quality of life improved in the pilot and real-world study.
Treatment tolerability
During chemotherapy, more patients completed the planned cycles (p = 0.03).
Applies to this raw material
All results apply to PMA-Zeolith®, not to zeolite in general.
Frequently asked questions about the evidence base
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Products with PMA-Zeolith®
All products contain the same tested raw material.
Content: 0.2 kg (€150.15 / 1 kg)
Content: 200 g (€17.45 / 100 g)
Content: 200 g (€0.17 / 1 g)
Content: 0.2 kg (€174.50 / 1 kg)
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