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

NCT04607018 | Completed

• 1 other identifier: MMBP_study
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Effects of the Elements

Outcome Measures

Primary Outcomes (5)

• Changes of Liver parameters

  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

  "Day 0" and "Day 28"

• Changes of renal parameters

  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

  "Day 0" and "Day 28"

• Changes of main standard mineral level in the blood

  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

  "Day 0" and "Day 28"

• Changes of main metal level in the blood

  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

  "Day 0" and "Day 28"

• Changes of Meathemoglobin in the blood

  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

  "Day 0" and "Day 28"

Study Arms (2)

Chronic intake group

ACTIVE COMPARATOR

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

Naive intake group

ACTIVE COMPARATOR

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

Device: PMA-zeolite

Interventions

PMA-zeolite DEVICE

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).

Chronic intake group; Naive intake group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• General Hospital Pula: lead

Related Publications (1)

• 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.

  PMID: 35712111 DERIVED

Study Officials

• Krešimir Pavelić, Phd, M.D.

  Juraj Dobrila University of Pula

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: no masking - all are taking the same products starting at different time points
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: October 28, 2020
• Study Start: November 17, 2015
• Primary Completion: May 13, 2016
• Study Completion: June 15, 2016
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share