Qualia Magnesium+® Placebo-Controlled Clinical Study Results

OVERVIEW OF QUALIA MAGNESIUM+ STUDY RESULTS

In a 12-week, placebo-controlled study, Qualia Magnesium+ was clinically studied to support healthy serum magnesium levels compared to placebo.†* The pre-registered primary endpoint — between-group change in RBC magnesium at 12 weeks — was not statistically significant. Serum magnesium, a secondary endpoint, was significantly higher in the Qualia Magnesium+ group than placebo at both 4 weeks and 12 weeks. Early signals supporting a healthy stress response were also observed at select timepoints during the study.<sup>†* 

†</sup> Based on a secondary outcome from a placebo-controlled study registered at ClinicalTrials.gov (NCT06979648). The pre-registered primary endpoint (between-group change in RBC magnesium at Week 12) was not statistically significant (p = 0.46). Serum magnesium and perceived stress were secondary endpoints.

HOW THE QUALIA MAGNESIUM+ STUDY WAS DESIGNED

There were two groups in the study: one took Qualia Magnesium+ capsules and the other took placebo capsules. Participants were randomly assigned to one of the two groups. 

The study was double-blinded, which means that neither the researchers conducting the study nor the participants knew who received Qualia Magnesium+ or placebo capsules until after the participants had completed the study protocol. Participants took either Qualia Magnesium+ or a placebo daily for 12 weeks. The instructions were to take two capsules every evening, with or without food. 

The primary study endpoint was the change in red blood cell (RBC) magnesium levels, determined by comparing initial and 12-week blood RBC magnesium results. Secondary endpoints included serum magnesium levels, perceived stress, sleep quality, and safety and tolerability.

The per-protocol analysis included 35 participants in the Qualia Magnesium+ group and 33 in the placebo group (n = 68). Participants ranged in age from 26 to 76 years old and were required to have baseline RBC magnesium below 6.0 mg/dL. [Note: The normal reference range for RBC magnesium in this study was 4.0 to 6.4 mg/dL.]* 

QUALIA MAGNESIUM+ STUDY RESULTS 

Changes in RBC Magnesium Were Not Significant* 

The pre-registered primary endpoint — the between-group change in RBC magnesium from baseline to 12 weeks — was not statistically significant (p = 0.46). An important context for this finding: at baseline, the majority of enrolled participants were already in the mid-normal to normal RBC magnesium range, which may have limited the study's ability to show improvement on this measure.* 

Qualia Magnesium+ Supported Healthy Serum Magnesium Levels Compared to Placebo^†* 

Among the secondary endpoints assessed, serum magnesium produced the clearest positive signal in the study. Participants taking Qualia Magnesium+ had significantly higher serum magnesium levels than those taking placebo at both 4 weeks (P < 0.001) and 12 weeks (P = 0.011) in the linear mixed-model analysis. Welch t-tests also confirmed significant differences at Day 28 (p < 0.001) and Day 84 (p = 0.009).^†* 

^† Based on a secondary outcome from a placebo-controlled study registered at ClinicalTrials.gov (NCT06979648). The pre-registered primary endpoint (between-group change in RBC magnesium at Week 12) was not statistically significant (p = 0.46). Serum magnesium was a secondary endpoint. 

Qualia Magnesium+ Was Studied to Support a Healthy Stress Response^††* 

Perceived stress, measured using the Perceived Stress Scale (PSS), showed early signals favoring Qualia Magnesium+. Between-group differences were observed at Days 14 and 42, with participants in the Qualia Magnesium+ group scoring approximately 3 points lower on perceived stress at Day 14 (p = 0.022).^††* 

Within the Qualia Magnesium+ group, PSS scores declined by an average of 43% over the 12-week study. The placebo group also improved from baseline (15% at Day 84), and the between-group difference at the final timepoint was not statistically significant.^††* 

^†† Based on a secondary outcome from a placebo-controlled study registered at ClinicalTrials.gov (NCT06979648). The pre-registered primary endpoint (between-group change in RBC magnesium at Week 12) was not statistically significant (p = 0.46). Perceived stress (PSS) was a secondary endpoint. Between-group significance observed at select timepoints (Days 14 and 42) during the study. 

Changes in Sleep Quality and Other Secondary Endpoints Were Not Significant* 

Sleep quality was assessed using the PROMIS Sleep Disturbance questionnaire. Both the Qualia Magnesium+ and placebo groups improved similarly from baseline throughout the study, and no meaningful between-group difference was observed at any timepoint.^†* Magnesium status survey scores also did not separate from placebo. Safety and tolerability were not significantly different between Qualia Magnesium+ and placebo groups, suggesting the product was well tolerated.* 

*These statements have not been evaluated by the Food and Drug Administration. The products and information on this website are not intended to diagnose, treat, cure or prevent any disease. The information on this site is for educational purposes only and should not be considered medical advice. Please speak with an appropriate healthcare professional when evaluating any wellness related therapy. Please read the full medical disclaimer before taking any of the products offered on this site.