Healthy Volunteers Clinical Trial
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).
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. ;
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