Body Composition ChangesNCT06703099
Magnesium Supplementation on Body Composition
A study testing Magnesium Supplementation in people with Body Composition Changes, run by Nova Southeastern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition Changes
- What is being tested?
- Magnesium Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to 27 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University HPD Annex Building
Davie, Florida, 33328
About this study
Official title: 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).
Read the 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.
- Conditions
- Body Composition Changes
- Being tested
- Magnesium Supplementation
- Keywords
- body composition, magnesium, lean body mass, InBody, Active, Pilot study
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SupplementationDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Supplementation | Experimental | Life Extension® Extend Release Magnesium 250 mg/day of oral magnesium in capsule form to be taken once a day at breakfast/morning. Receives: Dietary Supplement: Magnesium Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition - BMI
Using the InBody 270, height and weight will be combined to report BMI (kg/m2)
Measured: 8 weeks
Body Composition - Weight
Using the InBody 270, weight will be reported in pounds (lb)
Measured: 8 weeks
Body Composition - LBM
Using the InBody 270, lean body mass (LBM) will be reported in pounds (lb)
Measured: 8 weeks
Body Composition - BFM
Using the InBody 270, body fat mass (BFM) will be reported in pounds (lb)
Measured: 8 weeks
Secondary outcomes (1)
Dietary Intake
Dietary intake inclusive of Mg (in milligrams) in food items and total protein (in grams) using Food Logs
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start25 Sep 2024
- Primary completion20 Mar 2025
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Life Extension Foundation Inc.
- Responsible party
- Sponsor
- Investigators
- Madison M Doten, BS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703099
- Sponsor's protocol ID
- 2024-432-NSU
- Status last verified
- Jun 2025
- First submitted
- 10 Nov 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Supplementation on Body Composition in Physically Active Individuals: A Pilot Study
- ClinicalTrials.gov ID
- NCT06703099
- Acronym / sponsor ID
- 2024-432-NSU
- Conditions
- Body Composition Changes
- Keywords
- body composition, magnesium, lean body mass, InBody, Active, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Life Extension Foundation Inc.
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnesium Supplementation | Experimental | Dietary Supplement: Magnesium SupplementationLife Extension® Extend Release Magnesium 250 mg/day of oral magnesium in capsule form to be taken once a day at breakfast/morning. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SupplementationLife 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. | Dietary supplement | Magnesium Supplementation |
Primary outcome
Body Composition - BMI
Time frame: 8 weeks
Using the InBody 270, height and weight will be combined to report BMI (kg/m2)
Body Composition - Weight
Time frame: 8 weeks
Using the InBody 270, weight will be reported in pounds (lb)
Body Composition - LBM
Time frame: 8 weeks
Using the InBody 270, lean body mass (LBM) will be reported in pounds (lb)
Body Composition - BFM
Time frame: 8 weeks
Using the InBody 270, body fat mass (BFM) will be reported in pounds (lb)
1 secondary outcome
Dietary Intake
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madison M Doten, BS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Supplementation in people with Body Composition Changes, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition - BMI (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.