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

2026年10月31日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Noākhāli、孟加拉国、3814
        • Noakhali Science and Technology University, Noakhali-3814
        • 接触:
        • 首席研究员:
          • Tanveer Akik Ibne Alam, PhD candidate

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 28年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

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).

安慰剂比较: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.

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Muscle mass
大体时间: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
大体时间: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.

次要结果测量

结果测量
措施说明
大体时间
Body weight
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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.

其他结果措施

结果测量
措施说明
大体时间
Age
大体时间: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
大体时间: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
大体时间: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
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tanveer Akik Ibne Alam, PhD candidate、Food Technology and Nutrition Science

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月15日

初级完成 (估计的)

2027年1月11日

研究完成 (估计的)

2027年2月10日

研究注册日期

首次提交

2026年10月7日

首先提交符合 QC 标准的

2026年10月24日

首次发布 (实际的)

2026年10月30日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月31日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • NSTU/SCI/EC/2026/519

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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