Effect PMA-Zeolite on the Mineral Metabolism and Blood Parameters (MMBP Study)

General Hospital Pula

Status: Completed

Conditions: Effects of the Elements

Treatments: Device: PMA-zeolite

Study type: Interventional

Funder types: Other

Identifiers

NCT04607018

MMBP_study

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Chronic intake group

Active Comparator group

Description:

healthy subjects (control group) receive PMA-zeolite as powder. They take the product already before the study started (since 28 days before or even longer)

Treatment:

Device: PMA-zeolite

Naive intake group

Active Comparator group

Description:

healthy subjects (control group) receive PMA-zeolite as powder. They take the product only since the first day of the study

Treatment:

Device: PMA-zeolite