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

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

Interventions

DIETARY_SUPPLEMENT

Dietary supplementation with Microencapsulated Magnesium

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_SUPPLEMENT

Dietary supplementation with Magnesium Oxide

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_SUPPLEMENT

Dietary supplementation with Magnesium Citrate

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_SUPPLEMENT

Dietary supplementation with Magnesium Bisglycinate

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.

Sponsors & Collaborators

• Bionos Biotech S.L.

  lead INDUSTRY

Principal Investigators

• David Pajuelo Gamez, PhD · Bionos Biotech S.L.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-28

Primary Completion

2024-02-28

Completion

2024-03-29

Countries

• Spain

Study Locations