Magnesium Supplementation on Body Composition

Effects of Magnesium Supplementation on Body Composition in Physically Active Individuals: A Pilot Study

The goal of this interventional clinical trial is to learn if the supplementation of magnesium can affect body composition in physically active individuals between the ages of 18 and 30. The main question[s] it aims to answer [is/are]:

How does magnesium supplementation affect body composition in physically active individuals?

Participants will take a magnesium capsule once daily for 8 weeks, log their food intake into MyFitnessPal 3 days weekly for the 8 weeks, keep their physical activity consistent to their current regimen, and have 1 baseline appointment with 2 follow ups evenly dispersed (mid-point and post-intervention).

Study Overview

• Status: Completed
• Conditions: Body Composition Changes
• Intervention / Treatment: Dietary supplement: Magnesium Supplementation

Detailed Description

This study's research design is a pilot single-arm intervention trial. Data collection will occur three times (baseline, midpoint, and post-intervention) over the course of the 8 week intervention period. Data collection will take place on Nova Southeastern University Campus (3301 S University Dr, Davie, FL 33328). Eligible participants will undergo an 8-week supplementation regimen with Life Extension® Extend Release Magnesium, containing a 250 mg/capsule blend of ZümXR® magnesium oxide and magnesium citrate. The supplement will be distributed to participants at baseline and midpoint measurement assessments. Dietary intake will be monitored at least 3 days of the week for the 8 week intervention period using the MyFitnessPal app. Participants will be instructed not to change their eating habits for the duration of the intervention. Outside of their usual physical activity training, participants will be instructed not to change their physical activity habits for the duration of the intervention. Body composition will be assessed at baseline, midpoint, and post-intervention using Bioelectrical Impedance Analysis (BIA). Participants will be instructed to wear light clothing (with no zippers, belts, or buttons), remove all jewelry before testing, not consume any food 3-4 hours before testing, not drink caffeine on the day of testing, and hydrate adequately prior to testing. Demographic information (age, sex, and physical activity status) will be assessed via a simple questionnaire at baseline.

Order of events:

• Distribute recruitment through flyers at NSU Main Campus (Davie).
• Screening process via demographic survey to determine qualification based on participant inclusion/exclusion criteria.Sign consent forms, explain procedures and study outcomes to participants.
• Baseline anthropometric measurements (Bioelectrical Impedance Analysis (BIA) [InBody 270; InBody Co., Ltd. (Seoul, Korea)], height, and weight) and diet analysis (MyFitnessPal Nutrition Tracking App).
• Distribute supplements for the first 4 weeks of intervention (Life Extension Extend Release Magnesium, 28 capsules/participant).
• Bi-weekly follow ups with participants via phone (2 follow ups).
• Midpoint anthropometric measurements (BIA [InBody 270; InBody Co., Ltd. (Seoul, Korea)] and diet analysis (MyFitnessPal Nutrition Tracking App). Perform capsule counting.
• Distribute supplements for the last 4 weeks of intervention (Life Extension Magnesium Caps, 28 capsules/participant).
• Bi-weekly follow ups with participants via phone (2 follow ups).
• Final anthropometric measurements (BIA [InBody 270; InBody Co., Ltd. (Seoul, Korea)] and diet analysis (MyFitnessPal Nutrition Tracking App). Perform capsule counting.

Data collection:

Height and weight will be collected at baseline, midpoint, and post-intervention visits using weight scale and stadiometer. BMI will be calculated using height and weight. Body composition will be assessed using a multi-frequency Bioelectrical Impedance Analysis (BIA) device [InBody 270; InBody Co., Ltd. (Seoul, Korea)].

Participants will be required to keep a food diary for at least 3 days per week using the MyFitnessPal (MFP) Nutrition Tracking Smartphone Application. Similar software has been shown to produce results comparable to other, more time-intensive methods of dietary data collection such as 24-hour recalls. Participants' diets will be analyzed during the baseline and midpoint assessment visits using the MyFitnessPal (MFP) Nutrition Tracking App. Diet analyses will be conducted to determine how much dietary magnesium and protein participants are consuming in their normal diet, as both factors may affect LBM accrual.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Davie, Florida, United States, 33328
      • Nova Southeastern University HPD Annex Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-30 years old
• classified as a physically active individual for at least 1 year defined as being any individual that regularly engages in the minimum physical activity requirements as put forth by the American College of Sports Medicine.
• have a BMI of 19-30 kg/m2

Exclusion Criteria:

• smokers
• have been diagnosed with any metabolic/chronic disease
• are taking medications that can interfere with body composition
• are unwilling to follow study guidelines
• have a current physical condition that may be exacerbated by physical activity as determined by their general practitioner
• are pregnant or intend to become pregnant within 3 months
• have taken Mg supplements within the last 6 months
• are using steroids or any anabolic agents
• have pacemakers, implants, or any non-removable metal surgical implants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium Supplementation; Life Extension® Extend Release Magnesium 250 mg/day of oral magnesium in capsule form to be taken once a day at breakfast/morning.	Dietary supplement: Magnesium Supplementation; Life Extension® Extend Release Magnesium 250 mg/day of oral magnesium in capsule form to be taken once a day at breakfast/morning over 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition - BMI	Using the InBody 270, height and weight will be combined to report BMI (kg/m2)	8 weeks
Body Composition - Weight	Using the InBody 270, weight will be reported in pounds (lb)	8 weeks
Body Composition - LBM	Using the InBody 270, lean body mass (LBM) will be reported in pounds (lb)	8 weeks
Body Composition - BFM	Using the InBody 270, body fat mass (BFM) will be reported in pounds (lb)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Intake	Dietary intake inclusive of Mg (in milligrams) in food items and total protein (in grams) using Food Logs	8 weeks

Collaborators and Investigators

• Sponsor: Nova Southeastern University
• Collaborators: Life Extension Foundation Inc.
• Investigators: Principal Investigator: Madison M Doten, BS

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): April 27, 2025

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: body composition; Pilot study; magnesium; lean body mass; Active; InBody
• Other Study ID Numbers: 2024-432-NSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Statistical analysis of data will be shared, however individual documentation for participants will be kept on file and destroyed after 36 months as per IRB protocol. These documents will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No