Clinical Evaluation of the Magnesium Absorption Kinetics in Human Plasma Upon Oral Intake of Magnesium-based Products
Clinical Evaluation of the Magnesium Absorption Kinetics in Human Plasma Upon Oral Intake of Magnesium-based Products
NCT ID: NCT06225349 Phase: NA Status: COMPLETED Enrollment: 40 Completion: 2024-03-29
Conditions
Healthy Volunteers
Interventions
Dietary supplementation with Microencapsulated Magnesium, Dietary supplementation with Magnesium Oxide, Dietary supplementation with Magnesium Citrate, Dietary supplementation with Magnesium Bisglycinate
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).
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.