(PO19-15-22) A Combination of Magnesium, B Vitamins, Rhodiola, and Green Tea (L-theanine) Alleviates Chronic Stress in Healthy Volunteers: A Randomized, Placebo-Controlled Study

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Presenting Author(s)

GP

Gisèle Pickering, MD, PhD, DPharm
– Professor, C. H. U. of Clermont-Ferrand, Clermont-Ferrand Cedex, Auvergne, France

Co-Author(s)

LN

Lionel Noah, PhD
– Sanofi Consumer Healthcare
VM

Veronique Morel
– C.H.U. of Clermont-Ferrand
CB

Claire Bertin
– Sanofi Consumer Healthcare
EP

Etienne Pouteau, PhD
– SANOFI CONSUMER HEALTH CARE, Gentilly, Ile-de-France, France
CD

Christian Dualé
– C.H.U. of Clermont-Ferrand
NM

Nicolas Macian, Graduate Student
– University Hospital Clermont-Ferrand, Inserm CIC 1405, Clinical Investigation Center, France, Clermont-Ferrand Cedex 1, Auvergne, France
BP

Bruno Pereira
– C.H.U. of Clermont-Ferrand

Disclosure(s):

Gisèle Pickering, MD, PhD, DPharm: Sanofi Aventis: Grant/Research Support (Ongoing)

Objectives: The effect of a combination of magnesium, vitamin B6, B9, B12, and Teadiola^® (rhodiola and green tea/L-theanine extracts) on stress was evaluated in chronically stressed but otherwise healthy subjects. The effects on stress-related quality-of-life (QoL) parameters, like sleep and perception of pain were also explored.

Methods: This single-blinded study (NCT04391452) included adults with stress for ≥1 month and with ≥14 points on Depression Anxiety Stress Scale (DASS)-42 stress questionnaire. Subjects were randomized (1:1) to receive either the dietary supplement combination (n=49) or placebo (n=51), once daily, for 28 days, with a follow-up assessment at day 56.

Primary endpoint was the change in DASS-42 stress score from baseline (BL) to day 28 in dietary supplement vs placebo groups. Secondary endpoints included changes from BL in DASS-42 scores at days 14 and 56; sleep quality (Pittsburgh Sleep Quality Index [PSQI]) at days 14, 28, and 56; pain perception (temperature threshold) in response to cold/warm thermal stimulations at day 28.

Results: At BL, DASS-42 score (mean [SD]) was 26.3 (6.7) with dietary supplement and 26.8 (8.0) with placebo. At day 28, the scores decreased to 17.6 (7.3) and 20.1 (9.4), respectively, with a significant between-group difference of 3 points (effect size [ES], -0.29; 95% CI [-0.57, -0.01]; p=0.04). Similar reductions were observed earlier, at day 14 (ES, -0.40; 95% CI [-0.68, -0.11]; p=0.006), that remained stable up to day 56 (ES, -0.34; 95% CI [-0.62, -0.06]; p=0.02).

At day 28, a significant reduction in sensitivity to cold pain was reported with dietary supplement vs placebo (p=0.01) and a trend for lesser sensitivity to hot pain was observed (p=0.06).

No significant effect was observed on overall sleep quality, but a trend towards improvement in daytime dysfunction due to sleepiness (PSQI-7 component score) was noticed with dietary supplement vs placebo at day 28 (p=0.06) which became significant at day 56 (p < 0.001).

Conclusions: The combination is effective for management of stress in healthy individuals. Its beneficial effects on stress-related QoL aspects, notably pain perception, deserve further investigation.

Funding Sources: This study was sponsored by the University Hospital of Clermont-Ferrand, France and received partial financial support from Sanofi Consumer Healthcare, the manufacturer of Stress Resist^®.