Healthy VolunteersNCT06225349
Clinical Evaluation of the Magnesium Absorption Kinetics in Human Plasma Upon Oral Intake of Magnesium-based Products
A study testing Dietary supplementation with Microencapsulated Magnesium, Dietary supplementation with Magnesium Oxide and Dietary supplementation with Magnesium Citrate in people with Healthy Volunteers, run by Bionos Biotech S.L. at 1 site in Spain.
Trial summary
The goal of this clinical trial is to study the effect of four magnesium-based products on the magnesium concentration in plasma of volunteers upon oral intake. 40 healthy volunteers will be on a low magnesium diet for 1 week; then, after a 8-hour fasting, a blood sample will be taken from a digital puncture before (0… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dietary supplementation with Microencapsulated Magnesium, Dietary supplementation with Magnesium Oxide and Dietary supplementation with Magnesium Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jan 2024to 29 Mar 2024
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between 20 and 55 years of all races/ethnicities.
- Body mass index of 18-35 kg/m2.
- Last participation in a clinical study of this type must be at least 15 days before the start of this study.
- Fasting conditions during 8 hours before the experiment (with the exception of low mineralization water).
- No consumption of food supplements or specific food containing high levels of magnesium (see attachment) during the week before the start of the treatment.
Who cannot join
- People with gastrointestinal diseases (diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
- People with cardiorespiratory diseases (chronic bronchitis, chronic obstructive pulmonary disease, pulmonary emphysema, asthma and bronchiectasis, thrombi, heart disease, heart disorders, arrhythmias, insufficiencies, etc.).
- Pregnant or lactating women or who plan to become pregnant during the study.
- People under medical treatment in the weeks prior to the study that could interfere with the evaluations of the present study (according to the investigator's criteria).
- People who are within a dietary period outside their usual habit.
- People who demonstrate manifest incapacity to understand or follow the protocol or the informed consent.
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- Allergy or reactivity to any of the components of the product, or to a product with a category similar to the tested one.
- Surgically operated for a heart condition.
- People with forecast of changing routine or relevant way of life, during the period of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Improvement in Bioavailability of Four Magnesium-based Products in 40 Human Volunteers After an Oral Intake by Assessing Magnesium Absorption Kinetics in Plasma for 8 Hours
The goal of this clinical trial is to study the effect of four magnesium-based products on the magnesium concentration in plasma of volunteers upon oral intake. 40 healthy volunteers will be on a low magnesium diet for 1 week; then, after a 8-hour fasting, a blood sample will be taken from a digital puncture before (0 hours) and 1, 2, 4, 6 and 8 hours after the oral intake of one of the products. This 1-week procedure (1 week diet, fasting, oral intake of the product and sample collection) will be repeated for all 4 tested products, summing a total of 4 weeks (1 week per product). On the day of the sample collection, volunteers will be provided with a standardized low-magnesium breakfast (1:15 hours after oral intake), low-magnesium lunch (6:15 hours after oral intake) and water ad libitum. All the meal plans (products, quantities and hours of the meals) will be identical in all the periods of the study. Plasma will be obtained from blood samples by centrifugation and the magnesium concentration in plasma will be measured by ICP-MS (inductively coupled plasma mass spectrometry).
Read the detailed description
Magnesium is essential to the basic nucleic acid chemistry of all cells in all known living organisms. It is essential for DNA, RNA, and ATP synthesis, as well as for many other biological functions. Oral supplementation may improve the dietary intake of magnesium, which has been identified as a shortfall nutrient. In this study, the investigators will investigate the bioavailability of four magnesium-based products as food supplements by quantifying the magnesium levels in the plasma of volunteers after oral intake.
The study will be a double-blind trial to compare the bioavailability of four different magnesium products (Microencapsulated Magnesium, Magnesium Oxide, Magnesium Citrate and Magnesium Bisglycinate).
40 healthy volunteers between 20-55 years old will be enrolled in the study. Volunteers will be on a low magnesium diet for 1 week, including the consumption of low mineralization water; then, after a 8-hour fasting, a blood sample will be taken from a digital puncture before (0 hours) and 1, 2, 4, 6 and 8 hours after the oral intake of one of the products. This 1-week procedure (1 week diet, fasting, oral intake of the product and sample collection) will be repeated for all 4 tested products, summing a total of 4 weeks (1 week per product). On the day of the sample collection, volunteers will be provided with a standardized low-magnesium breakfast (1:15 hours after oral intake), low-magnesium lunch (6:15 hours after oral intake) and water ad libitum. All the meal plans (products, quantities and hours of the meals) will be identical in all the periods of the study. After every sample collection, participants will be allowed to leave the clinic, and asked to return at the required time-points. Volunteers will be requested not to practice any sport or to take part in any kind of strenuous exercise/activity during the day of collection.
Blood samples will be taken by digital puncture (non-invasive fingerstick procedure, by using VeriFine safety lancets 21G). The blood samples will be collected in EDTA-containing tubes (Minicollect tube K3E EDTA), centrifuged at 1000 rpm, 5 minutes at 4ºC, and plasma (supernatant) will be collected. Then, the magnesium levels in plasma will be measured by mass spectrometry ICP-MS (Mass Spectrometry with Inductively coupled plasma). The plasma samples of the 8-hour time point will not be analyzed by ICP-MS in principle, instead the samples will be stored at -80ºC and may be analyzed in further stages of the project.
There will be no consumption of supplements or specific food containing high levels of magnesium in the previous 7 days before the beginning of the experiment and during the experiment. Low mineralization water will be provided to the volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Dietary supplementation with Microencapsulated Magnesium, Dietary supplementation with Magnesium Oxide, Dietary supplementation with Magnesium Citrate, Dietary supplementation with Magnesium Bisglycinate
- Keywords
- magnesium, plasma, bioavailability, oral, ingestion, ICP-MS, food, supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementation with Microencapsulated MagnesiumDietary supplement
Volunteers will be provided with the product Microencapsulated Magnesium. For each volunteer, a blood sample from digital puncture will be obtained before (0 hour) and 1, 2, 4, 6, and 8 hours after oral intake of the product, and magnesium levels in plasma will be quantified by ICP-MS.
Dietary supplementation with Magnesium OxideDietary supplement
Volunteers will be provided with the product Magnesium Oxide. For each volunteer, a blood sample from digital puncture will be obtained before (0 hour) and 1, 2, 4, 6, and 8 hours after oral intake of the product, and magnesium levels in plasma will be quantified by ICP-MS.
Dietary supplementation with Magnesium CitrateDietary supplement
Volunteers will be provided with the product Magnesium Citrate. For each volunteer, a blood sample from digital puncture will be obtained before (0 hour) and 1, 2, 4, 6, and 8 hours after oral intake of the product, and magnesium levels in plasma will be quantified by ICP-MS.
Dietary supplementation with Magnesium BisglycinateDietary supplement
Volunteers will be provided with the product Magnesium Bisglycinate. For each volunteer, a blood sample from digital puncture will be obtained before (0 hour) and 1, 2, 4, 6, and 8 hours after oral intake of the product, and magnesium levels in plasma will be quantified by ICP-MS.
| Study group | Role | What they receive |
|---|---|---|
| Microencapsulated Magnesium | Experimental | This group will be provided with a the product Microencapsulated Magnesium. Receives: Dietary Supplement: Dietary supplementation with Microencapsulated Magnesium |
| Magnesium Oxide | Experimental | This group will be provided with a the product Magnesium Oxide. Receives: Dietary Supplement: Dietary supplementation with Magnesium Oxide |
| Magnesium Citrate | Experimental | This group will be provided with a the product Magnesium Citrate. Receives: Dietary Supplement: Dietary supplementation with Magnesium Citrate |
| Magnesium Bisglycinate | Experimental | This group will be provided with a the product Magnesium Bisglycinate. Receives: Dietary Supplement: Dietary supplementation with Magnesium Bisglycinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the changes of the magnesium levels in plasma of volunteers at time 0 hours (before consuming the product), and 1, 2, 4, 6, and 8 hours after oral intake of the product.
40 healthy volunteers will be on a low magnesium diet for 1 week; then, after a 8-h fasting, a blood sample will be taken from a digital puncture before (0 hour) and 1, 2, 4, 6 and 8 hours after the oral intake of one of the products. This 1-week procedure (1 week diet, fasting, oral intake of the product and sample collection) will be repeated for all 4 tested products, summing a total of 4 weeks (1 week per product). Blood samples will be taken by digital puncture (non-invasive fingerstick procedure, by using VeriFine safety lancets 21G). The blood samples will be collected in EDTA-containing tubes (Minicollect tube K3E EDTA), centrifuged at 1000 rpm, 5 minutes at 4ºC, and plasma (supernatant) will be collected. Then, the magnesium levels in plasma will be measured by mass spectrometry ICP-MS (Mass Spectrometry with Inductively coupled plasma) and expressed in mg magnesium per liter.
Measured: Upon oral intake, blood samples will be obtained by digital puncture at each time point; time 0 hours (before consuming the product), and 1, 2, 4, 6, and 8 hours after oral intake of the product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start28 Jan 2024
- Primary completion28 Feb 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionos Biotech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Pajuelo Gamez, PhD, Principal investigator, Bionos Biotech S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225349
- Sponsor's protocol ID
- MAGNESIUM_2023
- Status last verified
- Aug 2024
- First submitted
- 17 Jan 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Improvement in Bioavailability of Four Magnesium-based Products in 40 Human Volunteers After an Oral Intake by Assessing Magnesium Absorption Kinetics in Plasma for 8 Hours
- ClinicalTrials.gov ID
- NCT06225349
- Acronym / sponsor ID
- MAGNESIUM_2023
- Conditions
- Healthy Volunteers
- Keywords
- magnesium, plasma, bioavailability, oral, ingestion, ICP-MS, food, supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bionos Biotech S.L.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 25 Jan 2024 (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 goal of this clinical trial is to study the effect of four magnesium-based products on the magnesium concentration in plasma of volunteers upon oral intake. 40 healthy volunteers will be on a low magnesium diet for 1 week; then, after a 8-hour fasting, a blood sample will be taken from a digital puncture before (0 hours) and 1, 2, 4, 6 and 8 hours after the oral intake of one of the products. This 1-week procedure (1 week diet, fasting, oral intake of the product and sample collection) will be repeated for all 4 tested products, summing a total of 4 weeks (1 week per product). On the day of the sample collection, volunteers will be provided with a standardized low-magnesium breakfast (1:15 hours after oral intake), low-magnesium lunch (6:15 hours after oral intake) and water ad libitum. All the meal plans (products, quantities and hours of the meals) will be identical in all the periods of the study. Plasma will be obtained from blood samples by centrifugation and the magnesium concentration in plasma will be measured by ICP-MS (inductively coupled plasma mass spectrometry).
Detailed description
Magnesium is essential to the basic nucleic acid chemistry of all cells in all known living organisms. It is essential for DNA, RNA, and ATP synthesis, as well as for many other biological functions. Oral supplementation may improve the dietary intake of magnesium, which has been identified as a shortfall nutrient. In this study, the investigators will investigate the bioavailability of four magnesium-based products as food supplements by quantifying the magnesium levels in the plasma of volunteers after oral intake.
The study will be a double-blind trial to compare the bioavailability of four different magnesium products (Microencapsulated Magnesium, Magnesium Oxide, Magnesium Citrate and Magnesium Bisglycinate).
40 healthy volunteers between 20-55 years old will be enrolled in the study. Volunteers will be on a low magnesium diet for 1 week, including the consumption of low mineralization water; then, after a 8-hour fasting, a blood sample will be taken from a digital puncture before (0 hours) and 1, 2, 4, 6 and 8 hours after the oral intake of one of the products. This 1-week procedure (1 week diet, fasting, oral intake of the product and sample collection) will be repeated for all 4 tested products, summing a total of 4 weeks (1 week per product). On the day of the sample collection, volunteers will be provided with a standardized low-magnesium breakfast (1:15 hours after oral intake), low-magnesium lunch (6:15 hours after oral intake) and water ad libitum. All the meal plans (products, quantities and hours of the meals) will be identical in all the periods of the study. After every sample collection, participants will be allowed to leave the clinic, and asked to return at the required time-points. Volunteers will be requested not to practice any sport or to take part in any kind of strenuous exercise/activity during the day of collection.
Blood samples will be taken by digital puncture (non-invasive fingerstick procedure, by using VeriFine safety lancets 21G). The blood samples will be collected in EDTA-containing tubes (Minicollect tube K3E EDTA), centrifuged at 1000 rpm, 5 minutes at 4ºC, and plasma (supernatant) will be collected. Then, the magnesium levels in plasma will be measured by mass spectrometry ICP-MS (Mass Spectrometry with Inductively coupled plasma). The plasma samples of the 8-hour time point will not be analyzed by ICP-MS in principle, instead the samples will be stored at -80ºC and may be analyzed in further stages of the project.
There will be no consumption of supplements or specific food containing high levels of magnesium in the previous 7 days before the beginning of the experiment and during the experiment. Low mineralization water will be provided to the volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Microencapsulated Magnesium | Experimental | Dietary Supplement: Dietary supplementation with Microencapsulated MagnesiumThis group will be provided with a the product Microencapsulated Magnesium. |
| Magnesium Oxide | Experimental | Dietary Supplement: Dietary supplementation with Magnesium OxideThis group will be provided with a the product Magnesium Oxide. |
| Magnesium Citrate | Experimental | Dietary Supplement: Dietary supplementation with Magnesium CitrateThis group will be provided with a the product Magnesium Citrate. |
| Magnesium Bisglycinate | Experimental | Dietary Supplement: Dietary supplementation with Magnesium BisglycinateThis group will be provided with a the product Magnesium Bisglycinate. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers between 20 and 55 years of all races/ethnicities.
- Body mass index of 18-35 kg/m2.
- Last participation in a clinical study of this type must be at least 15 days before the start of this study.
- Fasting conditions during 8 hours before the experiment (with the exception of low mineralization water).
- No consumption of food supplements or specific food containing high levels of magnesium (see attachment) during the week before the start of the treatment.
Key exclusion criteria (9 listed)
- People with gastrointestinal diseases (diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
- People with cardiorespiratory diseases (chronic bronchitis, chronic obstructive pulmonary disease, pulmonary emphysema, asthma and bronchiectasis, thrombi, heart disease, heart disorders, arrhythmias, insufficiencies, etc.).
- Pregnant or lactating women or who plan to become pregnant during the study.
- People under medical treatment in the weeks prior to the study that could interfere with the evaluations of the present study (according to the investigator's criteria).
- People who are within a dietary period outside their usual habit.
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 |
|---|---|---|
| Dietary supplementation with Microencapsulated MagnesiumVolunteers will be provided with the product Microencapsulated Magnesium. For each volunteer, a blood sample from digital puncture will be obtained before (0 hour) and 1, 2, 4, 6, and 8 hours after oral intake of the product, and magnesium levels in plasma will be quantified by ICP-MS. | Dietary supplement | Microencapsulated Magnesium |
| Dietary supplementation with Magnesium OxideVolunteers will be provided with the product Magnesium Oxide. For each volunteer, a blood sample from digital puncture will be obtained before (0 hour) and 1, 2, 4, 6, and 8 hours after oral intake of the product, and magnesium levels in plasma will be quantified by ICP-MS. | Dietary supplement | Magnesium Oxide |
| Dietary supplementation with Magnesium CitrateVolunteers will be provided with the product Magnesium Citrate. For each volunteer, a blood sample from digital puncture will be obtained before (0 hour) and 1, 2, 4, 6, and 8 hours after oral intake of the product, and magnesium levels in plasma will be quantified by ICP-MS. | Dietary supplement | Magnesium Citrate |
| Dietary supplementation with Magnesium BisglycinateVolunteers will be provided with the product Magnesium Bisglycinate. For each volunteer, a blood sample from digital puncture will be obtained before (0 hour) and 1, 2, 4, 6, and 8 hours after oral intake of the product, and magnesium levels in plasma will be quantified by ICP-MS. | Dietary supplement | Magnesium Bisglycinate |
Primary outcome
Quantification of the changes of the magnesium levels in plasma of volunteers at time 0 hours (before consuming the product), and 1, 2, 4, 6, and 8 hours after oral intake of the product.
Time frame: Upon oral intake, blood samples will be obtained by digital puncture at each time point; time 0 hours (before consuming the product), and 1, 2, 4, 6, and 8 hours after oral intake of the product.
40 healthy volunteers will be on a low magnesium diet for 1 week; then, after a 8-h fasting, a blood sample will be taken from a digital puncture before (0 hour) and 1, 2, 4, 6 and 8 hours after the oral intake of one of the products. This 1-week procedure (1 week diet, fasting, oral intake of the product and sample collection) will be repeated for all 4 tested products, summing a total of 4 weeks (1 week per product). Blood samples will be taken by digital puncture (non-invasive fingerstick procedure, by using VeriFine safety lancets 21G). The blood samples will be collected in EDTA-containing tubes (Minicollect tube K3E EDTA), centrifuged at 1000 rpm, 5 minutes at 4ºC, and plasma (supernatant) will be collected. Then, the magnesium levels in plasma will be measured by mass spectrometry ICP-MS (Mass Spectrometry with Inductively coupled plasma) and expressed in mg magnesium per liter.
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 20 Aug 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
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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.
David Pajuelo Gamez, PhD principal investigator
Bionos Biotech S.L.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplementation with Microencapsulated Magnesium, Dietary supplementation with Magnesium Oxide and Dietary supplementation with Magnesium Citrate in people with Healthy Volunteers, run by Bionos Biotech S.L. at 1 site in Spain.
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 5 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 20 Aug 2024. 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 Spain. 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?
Quantification of the changes of the magnesium levels in plasma of volunteers at time 0 hours (before consuming the product), and 1, 2, 4, 6, and 8 hours after oral intake of the product. (time frame: Upon oral intake, blood samples will be obtained by digital puncture at each time point; time 0 hours (before consuming the product), and 1, 2, 4, 6, and 8 hours after oral intake of the product.). 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 20 Aug 2024.