Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Life Extension Foundation Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Supplementation | Dietary 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Madison M Doten, BS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Southeastern University HPD Annex Building | Davie | Florida | 33328 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 25, 2024 | Nov 9, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided