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

• ClinicalTrials.gov Identifier: NCT04607018
• Recruitment Status: Completed
• First Posted: October 28, 2020
• Last Update Posted: October 28, 2020
• Sponsor: General Hospital Pula
• Information provided by (Responsible Party): General Hospital Pula

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Effects of the Elements	Device: PMA-zeolite	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Masking Description: no masking - all are taking the same products starting at different time points
• Primary Purpose: Treatment
• Official Title: Effect of Panaceo Micro Activation (PMA)-Zeolite-Clinoptilolite on the Mineral Metabolism and Selected Blood Parameters (MMBP Study)
• Actual Study Start Date: November 17, 2015
• Actual Primary Completion Date: May 13, 2016
• Actual Study Completion Date: June 15, 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Chronic intake group; 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)	Device: PMA-zeolite; subjects received boxes containing PMA-zeolite powder for supplementation for a total of 28 days. Dosage for PMA-zeolite (100% zeolite; 1 ML - spoon for dosage = ca. 3 g zeolite):1 spoon of the powder stirred 2 times daily (morning and evening) in water (1 glass).
Active Comparator: Naive intake group; healthy subjects (control group) receive PMA-zeolite as powder. They take the product only since the first day of the study	Device: PMA-zeolite; subjects received boxes containing PMA-zeolite powder for supplementation for a total of 28 days. Dosage for PMA-zeolite (100% zeolite; 1 ML - spoon for dosage = ca. 3 g zeolite):1 spoon of the powder stirred 2 times daily (morning and evening) in water (1 glass).

Outcome Measures

Primary Outcome Measures :

1. Changes of Liver parameters [ Time Frame: "Day 0" and "Day 28" ]

   Biochemical evaluation of LIVER PARAMETERS (aspartate-aminotransferase, alanine-aminotransferase, gamma-glutamyltransferase)

   Referent values/range used for analyses:

   aspartate aminotransferase (AST): 8-38 U/L (Unit/litre) alanine aminotransferase (ALT): 10 - 48 U/L (Unit/litre) (lower values are not clinically relevant) Gamma-glutamyl transferase (GGT): Men: 11 - 55 U/L (Unit/litre) Woman: 9 - 35 U/L (Unit/litre)

   This parameters will be combined to report the LIVER function

   The statistical analysis will be performed between this three groups of data "Changes of standard blood parameters, main standard mineral level in the blood and main metal and contaminant in the blood " , time point at "Day 0" and "Day 28" in control group and healthy volunteer group and between the groups

2. Changes of renal parameters [ Time Frame: "Day 0" and "Day 28" ]

   Biochemical evaluation of RENAL PARAMETERS (creatinine, evaluation of the glomerular filtration speed will be done by use of a specific formula)

   Referent values/range used for analyses:

   CREAT: Woman: 63 - 107 µmol/L, Men: 79 - 125 µmol/L glomerular filtration (GF) - evaluation: G1>=90/ G2 60-80/G3a 45-59/G3b 30-40/G4 15-29/G5 <15. M: 11-32; F:8-30 µmol/l

   This parameters will be combined to report the RENAL function

   The statistical analysis will be performed between this three groups of data "Changes of standard blood parameters, main standard mineral level in the blood and main metal and contaminant in the blood " , time point at "Day 0" and "Day 28" in control group and healthy volunteer group and between the groups

3. Changes of main standard mineral level in the blood [ Time Frame: "Day 0" and "Day 28" ]

   Evaluation of standard mineral panel

   Analyses:

   Na and K assessment relie on indirect potentiometer analysis Zn concentrations in serum assessed by use of spectrophotometric method Biochemical evaluation of Fe, Ca and Mg were done by standard spectrophotometric methods.

   Evaluation of the glomerular filtration speed will be done by use of a specific formula.

   Referent values/ range used:

   Na: 137 - 146 mmol/L; K: 3,9 - 5,1 mmol/L; Zn: Men: 11,1-19,5 μmol/l, Woman:10,7-17,5 μmol/l; Fe: Men:11-32; Woman:8-30 umol/l Mg: 0,65 - 1,05 mmol/L Ca: 2,14 - 2,53 mmol/L

   The parameters will be combined for evaluation of the mineral metabolism

   The statistical analysis will be performed between this three groups of data "Changes of standard blood parameters, main standard mineral level in the blood and main metal and contaminant in the blood " , time point at "Day 0" and "Day 28" in control group and healthy volunteer group and between the groups

4. Changes of main metal level in the blood [ Time Frame: "Day 0" and "Day 28" ]

   Evaluation of main mineral panel

   for Pb, Hg, Cr, Cd, As, Al and Ni were inductively Coupled Plasma Mass Spectrometry-ICP-MS analysis of serum and plasma samples

   Referent values/range used:

   Lead (Pb) ≤ 50 µg/L Mercury (Hg) <10 µg/L Cadmium (Cd) < 1 µg/L Chromium (Cr) < 1 µg/L Arsenic (As) < 12µg/L Aluminium (Al) < 8 µg/L Nickel (Ni) < 2 µg/L

   The parameters will be combined for evaluation of the metal level

   The statistical analysis will be performed between this three groups of data "Changes of standard blood parameters, main standard mineral level in the blood and main metal and contaminant in the blood " , time point at "Day 0" and "Day 28" in control group and healthy volunteer group and between the groups

5. Changes of Meathemoglobin in the blood [ Time Frame: "Day 0" and "Day 28" ]

   Methemoglobinemia is a condition of elevated methemoglobin in the blood causing headache, dizziness, shortness of breath, nausea....

   Analyses for MHgb - methaemoglobin: The method relies on CO-oximetry by use of GEM OPLTM analyser

   Referent values/range used for analyses: methaemoglobin (MHgb) : 0-1,5%

   The statistical analysis will be performed between this three groups of data "Changes of standard blood parameters, main standard mineral level in the blood and main metal and contaminant in the blood " , time point at "Day 0" and "Day 28" in control group and healthy volunteer group and between the groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Sponsors and Collaborators

General Hospital Pula

Investigators

• Principal Investigator: Krešimir Pavelić, Phd, M.D.; Juraj Dobrila University of Pula

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: General Hospital Pula
• ClinicalTrials.gov Identifier: NCT04607018
• Other Study ID Numbers: MMBP_study
• First Posted: October 28, 2020
• Last Update Posted: October 28, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No