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A Summary of a Magnesium and Vitamin B6 Clinical Study by Pouteau et al. (2018)

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Reviewed by John Cutts, PhD | Research & Development

Overview

The following summary reviews clinical research examining oral magnesium supplementation, alone and in combination with vitamin B6, in the context of perceived stress in healthy adults with suboptimal serum magnesium concentrations.

Summary

Superiority of Magnesium and Vitamin B6 over Magnesium Alone on Severe Stress in Healthy Adults with Low Magnesemia: A Randomized, Single-Blind Clinical Trial

Published in:
PLOS ONE

Study Design:
Randomized, controlled, investigator-blinded clinical trial

Participants:
264 healthy adults aged 18–50 years with moderate to extremely severe stress (DASS-42 stress subscale score >18) and suboptimal serum magnesium concentrations (0.45–0.85 mmol/L); approximately 74% female

Dose:
300 mg elemental magnesium daily divided into three intakes, with or without 30 mg vitamin B6 daily, for 8 weeks

Outcome Measures:
Depression Anxiety Stress Scales (DASS-42) stress subscale score; erythrocyte magnesium concentrations; serum vitamin B6 levels; adverse event incidence

What Was Studied: A randomized clinical trial to evaluate whether combining magnesium with vitamin B6 produced greater reductions in perceived stress compared to magnesium supplementation alone, in healthy adults with moderate to extremely severe stress who also presented with suboptimal serum magnesium concentrations. Participants were randomized 1:1 to receive either a magnesium–vitamin B6 combination or magnesium alone over 8 weeks. The primary endpoint was change in DASS-42 stress subscale score from baseline to Week 8. Pre-specified subgroup analyses stratified by baseline stress severity were conducted following identification of a statistically significant interaction between baseline stress level and treatment group.

About the Reviewer

Name & Title: John Cutts, Director of Research at Solaray
Credentials: PhD Pharmacology & Toxicology

Bio: John Cutts, Ph.D. earned his Doctorate of Philosophy in Pharmacology and Toxicology from the University of Alabama at Birmingham and his Bachelors of Science in Chemistry from BYU-Idaho. He has nearly 20 years of experience in the dietary supplement space, with a focus on scientific substantiation, regulatory affairs, and product development. His graduate research centered on the health-related properties of botanical compounds. He currently works in research and development, where he evaluates clinical evidence for dietary supplement ingredients.

Reference

Pouteau E, Kabir-Ahmadi M, Noah L, Mazur A, Dye L, Hellhammer J, Pickering G, Dubray C. Superiority of magnesium and vitamin B6 over magnesium alone on severe stress in healthy adults with low magnesemia: A randomized, single-blind clinical trial. PLOS ONE. 2018;13(12):e0208454. https://pubmed.ncbi.nlm.nih.gov/30562392/

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Frequently Asked Questions

What makes a study “double-blind”?

In double-blind studies, participants and researchers are
both unaware of which participants are in the group taking the active
investigational product and which are part of a control group.

What makes a study “placebo-controlled”?

When studies are placebo-controlled one group takes an active
investigational product and the other group takes an inactive product that has
the same general appearances as the active treatment.

What is a placebo?

Placebos are inactive treatments. Researchers include placebos that have the same general characteristics as an active treatment.

They try to make them indistinguishable from the active treatment regarding
qualities like appearance, taste, and smell.

Why is statistical significance important?

Quality scientific studies look for more than just a numerical difference between treated groups and control groups. These studies also check mathematically for the possibility that any difference between groups might
happen by chance. A difference that is statistically significant is one where the change is not likely to be due to a chance fluctuation within a normal variance.

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

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