- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607018
Effect PMA-Zeolite on the Mineral Metabolism and Blood Parameters (MMBP Study)
Effect of Panaceo Micro Activation (PMA)-Zeolite-Clinoptilolite on the Mineral Metabolism and Selected Blood Parameters (MMBP Study)
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
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
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
"Day 0" and "Day 28"
|
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 |
"Day 0" and "Day 28"
|
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 |
"Day 0" and "Day 28"
|
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 |
"Day 0" and "Day 28"
|
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 |
"Day 0" and "Day 28"
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Krešimir Pavelić, PhD, M.D., Juraj Dobrila University of Pula
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MMBP_study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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