Indiana University
Bloomington, Indiana, 47405, United States
NCT Number: NCT04139928
Magnesium plays a role in an array of critical body functions, controls normal adenosine triphosphate function, the metabolism of glucose, and cardiac muscle function, as well as the maintenance of cell membrane function. Low magnesium intakes and blood levels have been associated with a number of chronic diseases including hypertension, type 2 diabetes, metabolic syndrome, vascular disease, osteoporosis, and colon cancer. Magnesium deficiency is common. In the U.S. population, nearly 4% of men and 7% of women have hypomagnesemia (typically defined as a serum concentration <0.75 mmol/L, or < 17mg/L), which has been previously shown to be associated with an increased risk of all-cause mortality after 30 years of follow-up. In addition, hypomagnesemia is seen in approximately 11% of hospitalized patients and 52% of patients in coronary care units. Approximately half of the U.S. population does not currently reach the estimated average requirement (EAR) for magnesium from food. Yet magnesium deficiency is often overlooked.
Magnesium is relatively well absorbed by the gut; oral bioavailability varies from 35 to 70% and depends on a variety of factors such as the form of the magnesium salt (organic vs. inorganic), its rate and extent of uptake from the intestine into the blood, and its transfer into tissues because magnesium is primarily an intracellular cation. The absorption rate increases when dietary intake is low. In terms of the effectiveness of oral dietary supplements, bioavailability and tolerability of various formulations are important considerations. Similar bioavailability has been demonstrated between inorganic formulations (magnesium oxide vs. magnesium chloride), however some studies have shown magnesium oxide to be less bioavailable. Diarrhea and abdominal cramping are side effects that are commonly reported from oral oral supplementation. These symptoms are thought to be due to the osmotic activity of unabsorbed salts in the intestine and colon and the stimulation of gastric motility. A new picometer-ionic form of magnesium chloride, was developed to efficiently deliver stabilized magnesium ions that are similar in size to plant magnesium. Picometer magnesium is smaller in diameter than the body's cell mineral ion channels, therefore it has the potential to be completely absorbed and not cause adverse side effects in the gastrointestinal system (e.g., diarrhea). The aim of this research is to assess the bioavailability of this new picometer-ionic form of magnesium chloride by comparing its bioavailability to that of a standard magnesium oxide and magnesium citrate supplement in healthy, adult, normotensive subjects.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Bloomington, Indiana, 47405, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single-dose (300 mg) of the picometer-ionic form of magnesium chloride
Single-dose (300 mg) of magnesium citrate or magnesium oxide
Placebo
Time frame: 24 hours
Ionized magnesium in whole blood is the primary outcome measure which will be measured by using a magnesium selective electrode clinical analyzer (Stat Profile Prime® Model, Prime Electrolyte System) at multiple time points following the oral doses of the magnesium supplements (MgCl vs MgO vs placebo). The time points will be -15 minutes prior to dose and post dose at 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour and 24 hour.
Time frame: 24 hours
Total magnesium in serum and urine are the secondary outcome measures which will be measured by using inductively coupled plasma-mass spectrometry (ICP-MS) at multiple time points following the oral doses of the magnesium supplements (MgCl vs MgO vs placebo). The time points for serum total magnesium will be -15 minutes prior to dose and post dose at 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour and 24 hour. Complete urine collections will be obtained at pooled intervals that coincide with timing of blood draws.
Time frame: 24 hours
A reference range for ionized magnesium in whole blood in healthy adults will be established for the magnesium selective electrode clinical analyzer.
Think Healthy Group, Inc.
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