Clinical trial NCT04607018: Effect PMA-Zeolite on the Mineral Metabolism and Blood Parameters (MMBP Study)
Official title: Effect of Panaceo Micro Activation (PMA)-Zeolite-Clinoptilolite on the Mineral Metabolism and Selected Blood Parameters (MMBP Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of the Elements
Lead sponsor: General Hospital Pula
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The pilot-study evaluated the effect of the PMA-zeolite supplementation of 28 days (in accordance with the regulations of this medical device) on 2 groups of 15 subjects (males and females) all together. All subjects are healthy volunteers taking PMA-zeolite since years and the other one just started. No washout phase is planned, but if food-supplements are taken this will be protocolled. The diagnostics will be performed through the defined parameters at defined time-points.
Primary purpose: TREATMENT

Brief summary: The Panaceo Micro Activation (PMA) -zeolite s a certified medical device throughout the European Union and absorbs defined harmful substances (mainly heavy metals and ammonium ions) in the gastrointestinal tract, while at the same time the alkaline ions contained in the crystal lattice are released (Mg2+, Ca2+, K+, Na+). Through a recent study the main-effect of zeolite was defined (support/ strengthen the intestinal wall barrier) and as a side-effect the measurement of the mineral metabolism was included, without documenting any significant changes. Its potential in releasing minerals needs to be investigated further to broaden the knowledge from previous study-outcomes as described. Broadening this knowledge through measuring defined blood-parameters was the aim of this human trial.

Detailed description: Background:

The ion-loaded natural PMA-zeolite do not act on the body as ion-robber in the digestive tract. The naturally occurring zeolites absorb defined ions in accordance to their selectivity alignment from their surroundings - e.g. in the gastrointestinal tract in the case of the specific certified PMA-zeolite. At the same time the PMA-zeolite absorbs defined harmful substances (mainly heavy metals and ammonium ions) in the gastrointestinal tract, while at the same time the alkaline ions contained in the crystal lattice are released (Mg2+, Ca2+, K+, Na+). Loaded with harmful substances, the zeolite is then excreted through the gastrointestinal tract without interfering with the body's metabolism.

The detoxification potential of zeolite was shown in various studies and the safety and efficacy is well documented. The measurement of the mineral metabolism was also included in a randomized controlled trial (RCT). The knowledge about its potential in releasing minerals needs however to be investigated further to broaden the knowledge from previous study-outcomes.

Methods/study-subjects:

Evaluation of the effect of the PMA-zeolite supplementation through analysis of defined blood-parameters before and after 28 days on two groups of 15 healthy volunteers (males and females) divided in NAiVE (started intake at day 1) and CHRONIC user group (intake of PMA-zeolite min. 28 before study-start).

Hypothesis:

Due to the defined effect mechanism of PMA-zeolite absorbing harmful substances (contaminants and heavy-metals) in the gastrointestinal tract and release of physiologically important minerals at the same time our hypothesis/ evaluated effects were that the PMA-zeolite has no negative impact on the mineral metabolism and might support. the natural body homeostasis, the measurement of the detoxification ability through a heavy-metal panel and other defined parameters.

Aims:

Aim of this intervention is hypothesized to lead to improvement of the enumerated values after an application after 28 days (NAiVE group).

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* at least 18 years old
* provided informed consent

Exclusion Criteria:

* chronic disease including:
* cancer,
* renal disease,
* neuro-degenerative,
* metabolic disorders,
* diabetic)
* recent vaccinations,
* pregnancy or breastfeeding,
* food supplements (if taken regularly this should be continued also during the study and documented)

Primary outcomes:
measure: Changes of Liver parameters
timeFrame: "Day 0" and "Day 28"
measure: Changes of renal parameters
timeFrame: "Day 0" and "Day 28"
measure: Changes of main standard mineral level in the blood
timeFrame: "Day 0" and "Day 28"
measure: Changes of main metal level in the blood
timeFrame: "Day 0" and "Day 28"
measure: Changes of Meathemoglobin in the blood
timeFrame: "Day 0" and "Day 28"
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Juraj Dobrila University of Pula
name: Krešimir Pavelić, Phd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraljevic Pavelic S, Saftic Martinovic L, Simovic Medica J, Zuvic M, Perdija Z, Krpan D, Eisenwagen S, Orct T, Pavelic K. Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients. Front Med (Lausanne). 2022 May 27;9:851782. doi: 10.3389/fmed.2022.851782. eCollection 2022.