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Effects of Daily Magnesium Complex Supplementation on Body Composition in University Students

31 oktober 2026 bijgewerkt door: Tanveer Akik Ibne Alam, Noakhali Science and Technology University

Effects of Daily Magnesium Complex Supplementation on Body Composition in University Students: A Double-Blind, Placebo-Controlled Randomized Trial

This study will investigate whether daily supplementation with 400 mg of magnesium from a triple magnesium complex containing magnesium glycinate, magnesium malate, and magnesium citrate can improve body composition in young adults. Participants will be randomly assigned to receive either the magnesium complex or a placebo once daily for 8 weeks. Body composition, including body weight, body mass index, body fat percentage, muscle mass, waist circumference, hip circumference, and waist-to-hip ratio, will be assessed before and after the intervention. The study will compare changes in these measures between the magnesium and placebo groups to determine whether daily magnesium supplementation has beneficial effects on body composition.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Magnesium is an essential mineral involved in numerous physiological processes, including energy metabolism, muscle function, protein synthesis, and maintenance of normal cellular function. Adequate magnesium status may contribute to the maintenance of healthy body composition and muscle-related outcomes. However, evidence regarding the effects of magnesium supplementation on body composition among healthy young adults remains limited. Therefore, this randomized, double-blind, placebo-controlled trial will investigate the effects of daily supplementation with a triple magnesium complex containing magnesium malate, magnesium glycinate, and magnesium citrate on body composition among healthy young adults.

The study will use an eight-week, randomized, double-blind, placebo-controlled, parallel-group design. Participants will be healthy adults aged 18 to 28 years with a body mass index (BMI) between 18 and 25 kg/m². Participants will be randomly allocated to either the magnesium supplementation group or the placebo group.

Participants assigned to the intervention group will receive 400 mg/day of a triple magnesium complex containing magnesium malate, magnesium glycinate, and magnesium citrate. The supplement will be administered as one capsule daily in the morning for 8 weeks (56 days) according to standardized instructions. Participants assigned to the placebo group will receive identical-appearing capsules containing microcrystalline cellulose and will follow the same administration schedule. The intervention and placebo preparations will be similarly packaged and labeled to maintain blinding.

Participants will be eligible if they are healthy adults aged 18-28 years with a BMI between 18 and 25 kg/m². Individuals will be excluded if they have chronic medical conditions requiring ongoing treatment, including cardiovascular disease, diabetes mellitus, hypertension, neurological disorders, cancer, epilepsy, renal or hepatic insufficiency, rheumatoid arthritis, multiple sclerosis, or gastrointestinal conditions such as Crohn's disease, pancreatic insufficiency, or ulcerative colitis. Additional exclusion criteria will include current smoking; use of sleep medications, magnesium-containing medications or supplements, laxatives, or hormone products; planned surgery within the next three months; participation in another clinical trial; excessive alcohol consumption; pregnancy; or breastfeeding.

Randomization will be performed using a predetermined random-number allocation sequence generated by a researcher independent of the study protocol. Participants will be assigned to either the magnesium or placebo group according to the random allocation sequence. To maintain allocation concealment and blinding, the study products will be provided in indistinguishable, unlabeled containers identified using participant numbers. Each participant will receive a sufficient supply of study capsules for the 8-week intervention period. Adherence will be assessed by counting returned capsules at the end of the intervention. Participants will be instructed to maintain their usual dietary intake and physical activity patterns throughout the study and to report any changes in medication, supplement use, or relevant lifestyle factors.

Blood samples will be collected at baseline and after completion of the 8-week intervention following an overnight fast of 10-12 hours. Serum samples will be obtained following centrifugation at 3,000-4,000 rpm for 10 minutes. Serum magnesium concentrations will be measured using the colorimetric method with VITROS Chemistry Products Mg Slides on the VITROS XT 7600 Integrated System.

Anthropometric and body composition measurements will be assessed at baseline and after the 8-week intervention. Body weight will be measured to the nearest 0.1 kg with participants wearing light clothing and no shoes. Height will be measured to the nearest 0.5 cm with participants standing barefoot in an upright position. BMI will be calculated as body weight in kilograms divided by height in meters squared. Body composition will be assessed using a TANITA SC-240 bioelectrical impedance analyzer. Body composition outcomes will include body fat mass, body fat percentage, and lean body mass. The calibration of the bioelectrical impedance analyzer will be checked according to the manufacturer's instructions before measurements.

Dietary intake will be assessed using two non-consecutive 24-hour dietary recalls, including one weekday and one weekend day. Dietary information will be collected through face-to-face interviews using standardized dietary assessment procedures. Physical activity will be assessed using the short-form International Physical Activity Questionnaire (IPAQ), with physical activity quantified in metabolic equivalent task minutes per week (MET-min/week). Information on sunlight exposure and other relevant lifestyle characteristics will also be collected. Dietary magnesium intake, physical activity, sunlight exposure, and other pre-specified baseline characteristics will be considered in the statistical analysis where appropriate.

Statistical analyses will be conducted using IBM SPSS Statistics version 26, with effect-size calculations and graphical analyses performed using R version 4.6.0. Continuous variables will be summarized using means and standard deviations, while categorical variables will be presented as frequencies and percentages. Distributional normality will be assessed using the Shapiro-Wilk test. Baseline continuous variables will be compared between treatment groups using the independent-samples t-test or Mann-Whitney U test, as appropriate, while categorical variables will be compared using the chi-square test. Within-group changes from baseline to post-intervention will be assessed using paired-samples t-tests or Wilcoxon signed-rank tests, as appropriate.

For the primary and secondary body composition outcomes, analysis of covariance (ANCOVA) will be used to evaluate post-intervention outcomes according to treatment group while adjusting for the corresponding baseline outcome and pre-specified covariates. Adjusted between-group treatment effects, 95% confidence intervals, and partial eta squared will be reported. Forest plots will be used to present adjusted treatment effects. Associations between changes in serum magnesium concentrations and changes in body composition outcomes will also be explored using Spearman's rank correlation coefficient and scatter plots. A two-sided p-value of less than 0.05 will be considered statistically significant.

The study protocol has been reviewed and approved by the Ethical Committee of Noakhali Science and Technology University (Approval No. NSTU/SCI/EC/2026/519). Written informed consent will be obtained from all participants before enrollment. Participants will be informed about the study objectives, procedures, potential benefits, and possible risks. Participation will be voluntary, and participants will have the right to withdraw from the study at any time without consequences. Participant confidentiality will be maintained by protecting identifying information and restricting access to study data to authorized members of the research team.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Bangladesh
      • Noākhāli, Bangladesh, 3814
        • Noakhali Science and Technology University, Noakhali-3814
        • Contact:
        • Hoofdonderzoeker:
          • Tanveer Akik Ibne Alam, PhD candidate

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 28 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. University students aged 18-28 years
  2. Students enrolled at Noakhali Science and Technology University (NSTU)

2. Body mass index (BMI) between 18.0 and 25.0 kg/m², inclusive

3. Willing to participate in the study and provide written informed consent

Exclusion Criteria:

  1. Known chronic diseases or medical conditions that may affect body composition or magnesium metabolism (cardiovascular disease (CVD), diabetes mellitus, hypertension, neurological disorder, cancer, epilepsy, renal or liver insufficiency, rheumatoid arthritis, multiple sclerosis, or gastrointestinal conditions like Crohn's disease, pancreatic insufficiency or ulcerative colitis )
  2. Current use of magnesium supplements or other supplements that may interfere with the study intervention
  3. Any condition that may prevent adherence to the 8-week intervention protocol

Unwillingness to provide informed consent or participate in the study procedures

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Magnesium Complex (Magnesium Malate, Magnesium Glycinate, and Magnesium Citrate)

Participants assigned to this arm will receive the assigned study product once daily in the morning for 8 weeks (56 days). Participants will be instructed to follow the prescribed administration schedule throughout the intervention period and maintain their usual dietary and physical activity patterns. Adherence will be assessed by counting the capsules returned at the end of the intervention.
Voedingssupplement: Triple Magnesium Complex

Thirty participants assigned to the magnesium group will receive 400 mg/day of a triple magnesium complex containing magnesium glycinate, magnesium malate, and magnesium citrate. The supplement will be administered orally as one capsule each morning for 8 weeks (56 days).
Placebo-vergelijker: Placebo (Microcrystalline Cellulose)

Participants assigned to this arm will receive the assigned study product once daily in the morning for 8 weeks (56 days). The product will be administered according to the same schedule and under the same study procedures as the experimental arm. Participants will be instructed to maintain their usual dietary and physical activity patterns throughout the intervention period, and adherence will be assessed by counting the capsules returned at the end of the intervention.
Voedingssupplement: Microcrystalline Cellulose Placebo

Microcrystalline cellulose capsules (as placebo) will be administer orally once daily in the morning for 8 weeks (56 days), following the same administration schedule as the magnesium complex intervention. The placebo will serve as the comparator in this double-blind, placebo-controlled randomized trial.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Muscle mass
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Muscle mass will be assessed at baseline and immediately after completion of the 8-week intervention using a calibrated TANITA SC-240 bioelectrical impedance analyzer. Change in muscle mass will be calculated for each participant by subtracting baseline muscle mass from Week 8 muscle mass. The change will be compared between the magnesium complex and placebo groups to evaluate the effect of daily magnesium complex supplementation on muscle mass in healthy young adults. Muscle mass will be expressed in kilograms (kg).
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.
Body composition
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Body fat percentage will be assessed at baseline and immediately after completion of the 8-week intervention using a calibrated TANITA SC-240 bioelectrical impedance analyzer. Change in body fat percentage will be calculated for each participant by subtracting the baseline body fat percentage from the Week 8 body fat percentage. The change will be compared between the magnesium complex and placebo groups to evaluate the effect of daily magnesium complex supplementation on body fat percentage in healthy young adults. Body fat percentage will be expressed as a percentage (%).
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body weight
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Body weight will be measured at baseline and immediately after completion of the 8-week intervention using standardized procedures. Change in body weight will be calculated for each participant by subtracting baseline body weight from body weight at Week 8. The change will be compared between the magnesium complex and placebo groups. Body weight will be expressed in kilograms (kg).
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.
Height
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Height will be measured at baseline and immediately after completion of the 8-week intervention using standardized procedures. Change in height will be calculated by subtracting baseline height from height at Week 8. Height will be expressed in centimeters (cm).
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.
Body mass index (BMI)
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Body mass index (BMI) will be assessed at baseline and immediately after completion of the 8-week intervention. BMI will be calculated by dividing body weight in kilograms by height in meters squared (kg/m²). Change in BMI will be calculated for each participant by subtracting baseline BMI from BMI at Week 8. The change will be compared between the magnesium complex and placebo groups. BMI will be expressed in kilograms per square meter (kg/m²).
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.
Waist circumference
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Waist circumference will be measured at baseline and immediately after completion of the 8-week intervention using standardized procedures. Change in waist circumference will be calculated by subtracting baseline waist circumference from waist circumference at Week 8. The change will be compared between the magnesium complex and placebo groups. Waist circumference will be expressed in centimeters (cm).
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.
Hip circumference
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Hip circumference will be measured at baseline and immediately after completion of the 8-week intervention using standardized procedures. Change in hip circumference will be calculated by subtracting baseline hip circumference from hip circumference at Week 8. The change will be compared between the magnesium complex and placebo groups. Hip circumference will be expressed in centimeters (cm).
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.
Waist-to-hip ratio
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Waist-to-hip ratio will be calculated at baseline and immediately after completion of the 8-week intervention by dividing waist circumference by hip circumference. Change in waist-to-hip ratio will be calculated by subtracting the baseline ratio from the Week 8 ratio. The change will be compared between the magnesium complex and placebo groups. Waist-to-hip ratio is dimensionless and has no unit of measurement.
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.
Serum magnesium concentration
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Serum magnesium concentration will be assessed at baseline and immediately after completion of the 8-week intervention. The change in serum magnesium concentration will be calculated for each participant by subtracting the baseline concentration from the Week 8 concentration. Changes will be compared between the magnesium complex and placebo groups to evaluate the effect of supplementation on serum magnesium levels. Serum magnesium concentration will be expressed in mg/dL.
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Age
Tijdsspanne: At baseline (before randomization).

Age will be recorded in completed years at baseline and treated as a continuous covariate in the statistical analysis.
At baseline (before randomization).
Sex
Tijdsspanne: At baseline (before randomization).

Sex will be recorded at baseline according to participants' reported information and included as a covariate in the statistical analysis.
At baseline (before randomization).
Sunlight exposure
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Sunlight exposure will be assessed at baseline and Week 8 using participants' reported duration of exposure and time of day. Exposure duration will be recorded in minutes or hours per day, and time of day will be categorized according to the study's predefined categories. Changes during the intervention will be assessed where applicable.
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.
Physical activity level
Tijdsspanne: Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Physical activity level will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at baseline and immediately after the 8-week intervention. Physical activity will be quantified as metabolic equivalent task minutes per week (MET-min/week), based on reported walking, moderate-intensity, and vigorous-intensity activities. The total score ranges from 0 MET-min/week to no fixed upper limit. Higher scores indicate greater physical activity. Physical activity may also be categorized as low, moderate, or high according to the standard IPAQ-SF scoring protocol.
Baseline assessment on November 15, 2026, before initiation of the intervention, and post-intervention assessment on January 10, 2027, after completion of the 8-week intervention.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Noakhali Science and Technology University

Onderzoekers

  • Hoofdonderzoeker: Tanveer Akik Ibne Alam, PhD candidate, Food Technology and Nutrition Science

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 november 2026

Primaire voltooiing (Geschat)

11 januari 2027

Studie voltooiing (Geschat)

10 februari 2027

Studieregistratiedata

Eerst ingediend

7 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 oktober 2026

Eerst geplaatst (Werkelijk)

30 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

31 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • NSTU/SCI/EC/2026/519

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant-level data (IPD) will not be shared with other researchers because the dataset contains participant-level information collected during the study. Data will be securely stored and accessed only by authorized members of the research team. Any results from the study will be reported in aggregate form to protect participant privacy and confidentiality. De-identified data may be considered for future research use subject to appropriate ethical approval and data-sharing requirements.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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