Effect of a Combination of Magnesium, B Vitamins, Rhodiola, and Green Tea (L-Theanine) on Chronically Stressed Healthy Individuals-A Randomized, Placebo-Controlled Study

Abstract

The effect of a combination of magnesium, vitamins B6, B9, B12, rhodiola and green tea/L-theanine (Mg-Teadiola) on stress was evaluated in chronically stressed, otherwise healthy individuals. Effects on stress-related quality-of-life parameters (sleep and perception of pain) were also explored. Adults with stress for ≥1 month, scoring ≥14 points on the Depression Anxiety Stress Scale (DASS)-42 questionnaire, were randomized (1:1) to receive oral Mg-Teadiola (n = 49) or a placebo (n = 51), for 28 days, with a follow-up assessment on Day 56 (NCT04391452). The primary endpoint was the change in the DASS-42 stress score from baseline to Day 28 with Mg-Teadiola versus placebo. The DASS-42 stress scores significantly decreased from baseline to Day 28 with Mg-Teadiola versus placebo (effect size, 0.29; 95% CI [0.01, 0.57]; p = 0.04). Similar reductions were observed on Day 14 (p = 0.006) and Day 56 (p = 0.02). A significant reduction in sensitivity to cold pain (p = 0.01) and a trend for lower sensitivity to warm pain was observed (p = 0.06) on Day 28. Improvements in daytime dysfunction due to sleepiness (Pittsburgh Sleep Quality Index-7 component score) were reported on Day 28, and were significant on Day 56 (p < 0.001). Mg-Teadiola is effective in managing stress in otherwise healthy individuals. Its beneficial effects on sleep and pain perception need further investigation.

Keywords: Depression Anxiety Stress Scale-42 questionnaire; L-theanine; Pittsburgh Sleep Quality Index; chronic stress; green tea; magnesium; pain; randomized clinical trial; rhodiola; vitamins.

Figure 1

Study design. DASS, Depression Anxiety Stress Scale; EOS, end of study; Mg-Teadiola, combination of 150 mg magnesium, 0.7 mg vitamin B6, 0.1 mg vitamin B9, and 1.25 µg vitamin B12, +222 mg of rhodiola extract and 125 mg of green tea extract including 50 mg of L-theanine; R, randomization.

Figure 2

Patient disposition. Mg-Teadiola, combination of 150 mg magnesium, 0.7 mg vitamin B6, 0.1 mg vitamin B9, and 1.25 µg vitamin B12, + 222 mg of rhodiola extract and 125 mg of green tea extract including 50 mg of L-theanine.

Figure 3

Proportion of participants with change in DASS-42 stress scores over time. BL, baseline; DASS, Depression Anxiety Stress Scale. Stress scores ranges: 0–14 (normal), 15–18 (mild), 19–25 (moderate), 26–33 (severe), and 34+ (extremely severe).

Figure 4

DASS-42 stress scores over time with Mg-Teadiola versus placebo. Mean (±SD) values are presented. Error bars represent SD. * p = 0.04 vs. Placebo; ** p = 0.006 vs. Placebo; * ^# p = 0.02 vs. Placebo. BL, baseline; DASS, Depression Anxiety Stress Scale; Mg-Teadiola, combination of 150 mg Mg, 0.7 mg vitamin B6, 0.1 mg vitamin B9, and 1.25 µg vitamin B12, +222 mg of rhodiola extract and 125 mg of green tea extract including 50 mg of L-theanine; SD, standard deviation. Stress scores ranges: 0–14 (normal); 15–18 (mild), 19–25 (moderate); 26–33 (severe) and 34+ (extremely severe).

Figure 5

Excretion of magnesium in urine over time with Mg-Teadiola versus placebo. Values are presented as Mean (SD). Error bars represent SD. BL, baseline; Mg, magnesium; Mg-Teadiola, combination of 150 mg magnesium, 0.7 mg vitamin B6, 0.1 mg vitamin B9, and 1.25 µg vitamin B12, +222 mg of rhodiola extract and 125 mg of green tea extract including 50 mg of L-theanine; SD, standard deviation.

Figure 6

Factorial Discriminant Analyses. Δ denotes a change on Day 28 for all participants (both Mg-Teadiola and placebo groups) C7 PSQI, Component 7 (daytime dysfunction) of PSQI, Mg-Teadiola, combination of 150 mg Mg, 0.7 mg vitamin B6, 0.1 mg vitamin B9, and 1.25 µg vitamin B12, +222 mg of rhodiola extract and 125 mg of green tea extract including 50 mg of L-theanine; PSQI, Pittsburgh Sleep Questionnaire Index; QST, Quantitative Somatosensory Thermotest.