Urea Cycle Disorders, InbornNCT02124330
Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models
A study testing montmorillonite 5 g, montmorillonite 3 g and Montmorillonite 1 g in people with Urea Cycle Disorders, Inborn and Other Metabolic Diseases, run by Luca Ronfani at 1 site in Italy.
Trial summary
Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical properties, such as swelling and cation exchange capability. The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake. Read more about this study
- Who is it for?
- Ages 25 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Urea Cycle Disorders, Inborn, Other Metabolic Diseases
- What is being tested?
- montmorillonite 5 g, montmorillonite 3 g and Montmorillonite 1 g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Apr 2015
- 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 25 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers (12M, 13 F, 25-30 years). Fasting from morning
Who cannot join
- not defined
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, 34137
About this study
Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical properties, such as swelling and cation exchange capability.
The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins.
Read the detailed description
Montmorillonite (MONT) is a phyllosilicate layered mineral; chemically it is hydrated sodium calcium aluminium magnesium silicate hydroxide. Potassium, iron, and other cations are common substitutes and the exact ratio of cations varies with source.
Due to its unique physicochemical properties, such as swelling and cation exchange capability, as well its mechanical and thermal stability, MONT can be efficiently used as matrix for immobilization of proteins with high molecular weight (e.g. Albumin) and proteins with low molecular weight (e.g.Aflatoxines). Therefore, MONT is used for therapeutic purposes, in pharmaceutical formulations and in food preparations. In vitro assays made in our laboratory, showed that MONT absorbs, in stable manner, alimentary proteins: beta-lactoglobulins, alfa lactoalbumines and the ratio MONT-protein (w/w) 1:3, 1:5, 1:15, results in the protein capture of 50, 27, 0 % of proteins respectively.
The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake evaluated with the blood MONT- protein ratio. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins at different ratio (w/w) 1:3, 1:5, 1:15.
- Being tested
- montmorillonite 5 g, montmorillonite 3 g, Montmorillonite 1 g
- Keywords
- Montmorillonite, proteic diet, in vitro and in vivo models
- Medical subject headings
- Urea Cycle Disorders, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montmorillonite 5 gDietary supplement
5g montmorillonite + 15 g protein (ratio 1:3)
montmorillonite 3 gDietary supplement
3g MONT+ 15 g protein (ratio 1:5)
Montmorillonite 1 gDietary supplement
1g MONT+ 15 g protein (ratio 1:15)
| Study group | Role | What they receive |
|---|---|---|
| montmorillonite 5 g | Experimental | 5g Montmorillonite + 15 g protein (ratio 1:3) Receives: Dietary Supplement: montmorillonite 5 g |
| Montmorillonite 3 g | Experimental | 3g Montmorillonite + 15 g protein (ratio 1:5) Receives: Dietary Supplement: montmorillonite 3 g |
| Montmorillonite 1 g | Experimental | 1g Montmorillonite + 15 g protein (ratio 1:15) Receives: Dietary Supplement: Montmorillonite 1 g |
| Control | No intervention | A control goup will intake 15 g of protein alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein uptake evaluated with the blood MONT-protein ratio
A solution of MONT and whey protein dissolved in 200 ml of water at the three different ratios will be administered. The control group will intake 15g of protein alone.
Blood samples will be centrifuged and analyzed by mass spectrometry (egilent HP5973 mass spectrometry).
Measured: before administration and 30, 60, 90, 120 ,180 minutes after
Secondary outcomes (1)
Protein absorption by MONT in vitro
MONT and protein (whey protein) at three different ratio w/w (1:3, 1:5, 1:15) will be dissolved in acetate buffer 0.1M pH5 as well as a sample without MONT.
Samples will incubate at RT for 1, 10, 30, 60 minutes and then centrifugate at 13000g.
The surnatant will be analyzed by LOWRY method. Protein concentration will be expressed in mg/ml. The MONT ability of immobilization will be calculated respect to the protein control sample
Measured: at time of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urea Cycle Disorders, InbornStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luca Ronfani
- Sponsor type
- University, hospital or other
- Collaborators
- University of Trieste
- Responsible party
- Sponsor-investigator, Luca Ronfani, IRCCS Burlo Garofolo
- Investigators
- Tarcisio Not, MD, Principal investigator, Institute for Maternal and Child Health IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124330
- Sponsor's protocol ID
- RC 06-13
- Other IDs
- RC 06/13
- Status last verified
- Mar 2017
- First submitted
- 21 Oct 2013
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models
- ClinicalTrials.gov ID
- NCT02124330
- Acronym / sponsor ID
- RC 06-13
- Keywords
- Montmorillonite, proteic diet, in vitro and in vivo models
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Luca RonfaniUniversity, hospital or other
- Collaborators
- University of Trieste
- Study start
- Jun 2013 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Apr 2014 (estimated)
- 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.
Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical properties, such as swelling and cation exchange capability.
The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins.
Detailed description
Montmorillonite (MONT) is a phyllosilicate layered mineral; chemically it is hydrated sodium calcium aluminium magnesium silicate hydroxide. Potassium, iron, and other cations are common substitutes and the exact ratio of cations varies with source.
Due to its unique physicochemical properties, such as swelling and cation exchange capability, as well its mechanical and thermal stability, MONT can be efficiently used as matrix for immobilization of proteins with high molecular weight (e.g. Albumin) and proteins with low molecular weight (e.g.Aflatoxines). Therefore, MONT is used for therapeutic purposes, in pharmaceutical formulations and in food preparations. In vitro assays made in our laboratory, showed that MONT absorbs, in stable manner, alimentary proteins: beta-lactoglobulins, alfa lactoalbumines and the ratio MONT-protein (w/w) 1:3, 1:5, 1:15, results in the protein capture of 50, 27, 0 % of proteins respectively.
The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake evaluated with the blood MONT- protein ratio. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins at different ratio (w/w) 1:3, 1:5, 1:15.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| montmorillonite 5 g | Experimental | Dietary Supplement: montmorillonite 5 g5g Montmorillonite + 15 g protein (ratio 1:3) |
| Montmorillonite 3 g | Experimental | Dietary Supplement: montmorillonite 3 g3g Montmorillonite + 15 g protein (ratio 1:5) |
| Montmorillonite 1 g | Experimental | Dietary Supplement: Montmorillonite 1 g1g Montmorillonite + 15 g protein (ratio 1:15) |
| Control | No intervention | –A control goup will intake 15 g of protein alone |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers (12M, 13 F, 25-30 years). Fasting from morning
Key exclusion criteria (1 listed)
- not defined
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 |
|---|---|---|
| montmorillonite 5 g5g montmorillonite + 15 g protein (ratio 1:3) | Dietary supplement | montmorillonite 5 g |
| montmorillonite 3 g3g MONT+ 15 g protein (ratio 1:5) | Dietary supplement | Montmorillonite 3 g |
| Montmorillonite 1 g1g MONT+ 15 g protein (ratio 1:15) | Dietary supplement | Montmorillonite 1 g |
Primary outcome
Protein uptake evaluated with the blood MONT-protein ratio
Time frame: before administration and 30, 60, 90, 120 ,180 minutes after
A solution of MONT and whey protein dissolved in 200 ml of water at the three different ratios will be administered. The control group will intake 15g of protein alone. Blood samples will be centrifuged and analyzed by mass spectrometry (egilent HP5973 mass spectrometry).
1 secondary outcome
Protein absorption by MONT in vitro
Time frame: at time of the trial
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 9 Mar 2017.
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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.
Tarcisio Not, MD principal investigator
Institute for Maternal and Child Health IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing montmorillonite 5 g, montmorillonite 3 g and Montmorillonite 1 g in people with Urea Cycle Disorders, Inborn and Other Metabolic Diseases, run by Luca Ronfani at 1 site in Italy.
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 1 inclusion and 1 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Protein uptake evaluated with the blood MONT-protein ratio (time frame: before administration and 30, 60, 90, 120 ,180 minutes after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2017.