Bioavailability of Single-dose Magnesium Salts

Last updated: April 21, 2024
Sponsor: Think Healthy Group, Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Magnesium citrate or magnesium oxide

Picometer-ionic form of magnesium chloride

Placebo

Clinical Study ID

NCT04139928
THG-IU-MG-1
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18- 65 years
  2. Body mass index 18 to 35 kg/m2 , body weight ≥ 110 pounds or 50 kg
  3. All race/ethnicities and both sexes, are eligible.
  4. Normal blood pressure (BP) ≤ 120/80 mm Hg.

Exclusion

Exclusion Criteria:

  1. Participant has a diagnosis of hypertension, prehypertension, diabetes, cardiovascularor other chronic disease (e.g., cancer).
  2. Participant has a diagnosis of hypermagnesemia (defined as a serum concentration of > 22.8 mg/L of Magnesium) (4).
  3. Participant is already taking magnesium supplementation prior to the study or takingmedications that interfere with magnesium metabolism, we are providing examples in anappendix.
  4. Participant has concurrent use of magnesium supplements and/or other nutrientsupplements that interfere with magnesium absorption (e.g., calcium supplements)within 2-wk prior the first treatment or during the course of this study.
  5. Participant has gastrointestinal disease, hepatitis, anemia, or hepatic enzymeabnormalities.
  6. Women subjects are currently pregnant or trying to become pregnant.
  7. Participant has a history of hospitalization for acute illness in the previous 1month.
  8. Participants who do not speak English or are unable to read or fail to comprehend theinformed consent form.
  9. Participants fail to complete the full medical questionnaire reviewed with them duringthe initial phone call (whether it be because they refuse to answer or because theydon't know/understand the questions).
  10. Participants who have a body weight less than 110lbs (or 50kg).
  11. Participants who have donated blood within the last month, or are currently givingblood for other clinical or research purposes.
  12. Participants who smoke and/or use tobacco products.

Study Design

Total Participants: 17
Treatment Group(s): 3
Primary Treatment: Magnesium citrate or magnesium oxide
Phase:
Study Start date:
August 01, 2018
Estimated Completion Date:
April 28, 2020

Connect with a study center

  • Indiana University

    Bloomington, Indiana 47405
    United States

    Site Not Available

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