The possible “calming effect” of subchronic supplementation of a standardised phospholipid carrier-based Melissa officinalis L. extract in healthy adults with emotional distress and poor sleep conditions: results from a prospective, randomised, double-blinded, placebo-controlled clinical trial

Abstract

Background: Emotional distress conditions such as depression, anxiety, stress, and poor sleep are widespread health problems that have a significant impact on people’s lives. Conventional drugs are commonly prescribed to treat emotional distress and poor sleep conditions; however, these medications have several limitations and have shown multiple side effects. Over recent years botanicals-based pharmacological agents have gained increasing research and clinical interest in the management of emotional distress and sleep disorder. Of note, Melissa officinalis L. (MO) leaf extract has demonstrated considerable neuropharmacological properties both in animal and human studies and has emerged as a promising natural “calming agent.” However, research in this area is limited, and more studies are needed to validate its efficacy in amelioration of emotional distress and poor sleep conditions.Objectives: We aimed to assess the pharmacological effects of subchronic supplementation of an innovative standardised phospholipid carrier-based MO aqueous extract on emotional distress and poor sleep conditions.Design: A 3-week prospective, randomised, placebo-controlled, parallel-group, double-blinded clinical trial was conducted in 100 healthy adults complaining of a moderate degree of depression, anxiety, or stress, with scores of ≥14, ≥10, and ≥19, respectively, in the self-report Depression, Anxiety, and Stress Scale (DASS-42) or poor sleep, as indicated by the score of >5 in the Pittsburgh Sleep Quality Index (PSQI) scale. In addition, the impact of emotional distress and/or poor sleep on participants’ mental wellbeing, emotional feelings, and quality of life was also assessed using the self-reported Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS), Positive and Negative Affect Schedule (PANAS) scale, and quality of life (WHO-QoL-BREF) scale, respectively.Results: Oral supplementation of 200 mg of phospholipid-based MO aqueous extract (Relissa™) tablets twice a day (i.e., 400 mg/day) for 3 weeks led to significant improvements in the depressive mood, anxiety, stress, positive and negative affect (emotional feelings), overall mental wellbeing, and quality-of-life scores (all p values <0.001). Supplementation of MO extract was well tolerated, and no treatment-emergent effects or serious adverse events were reported.Conclusion: According to the results of this study, the phospholipid carrier-based MO aqueous extract possesses considerable neuropharmacological properties, and its supplementation may provide a promising therapeutic option for the management of moderate emotional distress and/or poor sleep conditions.Clinical Trial Registration:clinicaltrials.gov, identifier NCT05602688.

An in vitro analysis of an innovative standardized phospholipid carrier-based Melissa officinalis L. extract as a potential neuromodulator for emotional distress and related conditions

“…It is noteworthy that the results of the present study suggest that the Phytosome™ carrier system allows an enhancing power of MO leaf extract phytonutrients, as suggested by other studies on botanical extracts ( Riva et al, 2019a ; Riva et al, 2019b ; Rondanelli et al, 2021 ; Pivari et al, 2022 ; Bano et al, 2023 ). The application of the Phytosome™ carrier technology to the MO extract allowed it to confer more stability to oxidation and cellular accessibility compared to unformulated MO extract, with consequent benefits of improved biological activity.…”

“…Based on the results of the revealed mechanisms of action investigated in the present study, Bano et al (2023) carried out a perspective, double-blinded, placebo-controlled randomized clinical trial of Relissa™ supplementation in healthy adults with a moderate level of depression, anxiety, stress, and sleep disorders. The clinical outcomes confirmed a significant improvement in all the above-mentioned conditions of emotional distress in subjects who received the Relissa™ supplementation compared to those who received the placebo, supporting the beneficial effects of Relissa™ supplementation in low-mood states.…”

“…Assays were carried out with an innovative phospholipid (sunflower lecithin) (Phytosome ™ ) carrier-based MO extract (Relissa ™ ) (Bano et al, 2023) and an unformulated dry MO extract (not mixed with a carrier system), both supplied by Indena S.p.A. (Milan, Italy). Relissa ™ is an innovative formulation of the MO extract mixed with the Phytosome ™ carrier system, which has been standardized and contains 17%-23% hydroxycinnamic acid derivatives and analyzed for its rosmarinic acid content.…”