Effects of the ElementsNCT04607018
Effect PMA-Zeolite on the Mineral Metabolism and Blood Parameters (MMBP Study)
A study testing PMA-zeolite in people with Effects of the Elements, run by General Hospital Pula.
Trial 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+… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effects of the Elements
- What is being tested?
- PMA-zeolite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2015to 15 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
- at least 18 years old
- provided informed consent
Who cannot join
- chronic disease including:
- cancer,
- renal disease,
- neuro-degenerative,
- metabolic disorders,
- diabetic)
Show all 9Show fewer
- recent vaccinations,
- pregnancy or breastfeeding,
- food supplements (if taken regularly this should be continued also during the study and documented)
About this study
Official title: Effect of Panaceo Micro Activation (PMA)-Zeolite-Clinoptilolite on the Mineral Metabolism and Selected Blood Parameters (MMBP Study)
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.
Read the 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).
- Conditions
- Effects of the Elements
- Being tested
- PMA-zeolite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMA-zeoliteDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Device: PMA-zeolite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: "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
Measured: "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
Measured: "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
Measured: "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
Measured: "Day 0" and "Day 28"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start17 Nov 2015
- Primary completion13 May 2016
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of the ElementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Pula
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krešimir Pavelić, Phd, M.D., Principal investigator, Juraj Dobrila University of Pula
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607018
- Sponsor's protocol ID
- MMBP_study
- Status last verified
- Oct 2020
- First submitted
- 18 May 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35712111
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Panaceo Micro Activation (PMA)-Zeolite-Clinoptilolite on the Mineral Metabolism and Selected Blood Parameters (MMBP Study)
- ClinicalTrials.gov ID
- NCT04607018
- Acronym / sponsor ID
- MMBP_study
- Conditions
- Effects of the Elements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- General Hospital PulaUniversity, hospital or other
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 13 May 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chronic intake group | Active comparator | Device: PMA-zeolitehealthy subjects (control group) receive PMA-zeolite as powder. They take the product already before the study started (since 28 days before or even longer) |
| Naive intake group | Active comparator | Device: PMA-zeolitehealthy subjects (control group) receive PMA-zeolite as powder. They take the product only since the first day of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy volunteers
- at least 18 years old
- provided informed consent
Key exclusion criteria (9 listed)
- chronic disease including:
- cancer,
- renal disease,
- neuro-degenerative,
- metabolic disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMA-zeolitesubjects 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). | Device | Chronic intake group, Naive intake group |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 35712111Kraljevic 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krešimir Pavelić, Phd, M.D. principal investigator
Juraj Dobrila University of Pula
Questions about this trial
What is this clinical trial studying?
A study testing PMA-zeolite in people with Effects of the Elements, run by General Hospital Pula.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Liver parameters (time frame: "Day 0" and "Day 28"). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.