Clinical Evaluation of the Magnesium Absorption Kinetics in Human Plasma Upon Oral Intake of Magnesium-based Products

NCT06225349 | Completed

• 1 other identifier: MAGNESIUM_2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Healthy Volunteers

Keywords

magnesium; plasma; bioavailability; oral; ingestion; ICP-MS; food; supplement

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (4)

Microencapsulated Magnesium

EXPERIMENTAL

This group will be provided with a the product Microencapsulated Magnesium.

Dietary Supplement: Dietary supplementation with Microencapsulated Magnesium

Magnesium Oxide

EXPERIMENTAL

This group will be provided with a the product Magnesium Oxide.

Dietary Supplement: Dietary supplementation with Magnesium Oxide

Magnesium Citrate

EXPERIMENTAL

This group will be provided with a the product Magnesium Citrate.

Dietary Supplement: Dietary supplementation with Magnesium Citrate

Magnesium Bisglycinate

EXPERIMENTAL

This group will be provided with a the product Magnesium Bisglycinate.

Dietary Supplement: Dietary supplementation with Magnesium Bisglycinate

Interventions

Dietary supplementation with Microencapsulated Magnesium DIETARY_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.

Microencapsulated Magnesium

Dietary supplementation with Magnesium Oxide DIETARY_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.

Magnesium Oxide

Dietary supplementation with Magnesium Citrate DIETARY_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.

Magnesium Citrate

Dietary supplementation with Magnesium Bisglycinate DIETARY_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.

Magnesium Bisglycinate

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Bionos Biotech S.L.: lead

Study Sites (1)

Bionos Biotech S.L.

Valencia, 46026, Spain

Location

MeSH Terms

Interventions

Dietary Supplements; Magnesium Oxide; magnesium citrate

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• David Pajuelo Gamez, PhD

  Bionos Biotech S.L.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 25, 2024
• Study Start: January 28, 2024
• Primary Completion: February 28, 2024
• Study Completion: March 29, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)