A proprietary black cumin oil extract (Nigella sativa) (BlaQmax®) modulates stress-sleep-immunity axis safely: Randomized double-blind placebo-controlled study

Abstract

ObjectiveStress, sleep, and immunity are important interdependent factors that play critical roles in the maintenance of health. It has been established that stress can affect sleep, and the quality and duration of sleep significantly impact immunity. However, single drugs capable of targeting these factors are limited because of their multi-targeting mechanisms. The present study investigated the influence of a proprietary thymoquinone-rich black cumin oil extract (BCO-5) in modulating stress, sleep, and immunity.MethodsA randomized double-blinded placebo-controlled study was carried out on healthy volunteers with self-reported non-refreshing sleep issues (n = 72), followed by supplementation with BCO-5/placebo at 200 mg/day for 90 days. Validated questionnaires, PSQI and PSS, were employed for monitoring sleep and stress respectively, along with the measurement of cortisol and melatonin levels. Immunity markers were analyzed at the end of the study.ResultsIn the BCO-5 group, 70% of the participants reported satisfaction with their sleep pattern on day 7 and 79% on day 14. Additionally, both inter- and intra- group analyses of the total PSQI scores and component scores (sleep latency, duration, efficiency, quality, and daytime dysfunction) on days 45 and 90 showed the effectiveness of BCO-5 in the improvement of sleep (p < 0.05). PSS-14 analysis revealed a significant reduction in stress, upon both intra (p < 0.001) and inter-group (p < 0.001) comparisons. The observed reduction in stress among the BCO-5 group, with respect to the placebo, was significant with an effect size of 1.19 by the end of the study (p < 0.001). A significant correlation was also observed between improved sleep and reduced stress as evident from PSQI and PSS. Furthermore, there was a significant modulation in melatonin, cortisol, and orexin levels. Hematological/immunological parameters further revealed the immunomodulatory effects of BCO-5.ConclusionBCO-5 significantly modulated the stress-sleep-immunity axis with no side effects and restored restful sleep.

Exploring the short-term influence of a proprietary oil extract of black cumin (Nigella sativa) on non-restorative sleep: a randomized, double-blinded, placebo-controlled actigraphy study

“…Increased cortisol level was generally correlated with reduced NREM and REM stages. In another recent randomized controlled study employing Pittsburgh sleep quality questionnaire (PSQI), more than 70% of participants treated with BCO-5 at 200 mg/day were satisfied with their sleep improvement in 7 days ( 47 ).…”

“…Recently we had reported the influence of BCO-5 on the hypothalamus-pituitary–adrenal (HPA)-axis to act as a dual orexin receptor antagonist (DORA) and hence to modulate cortisol/melatonin levels and thereby to balance stress/sleep and sleep/wake cycle ( 47 ). Inhibition of orexin activation can reduce cortisol and promote sleep signals by enhancing melatonin.…”

A randomized, double-blind, parallel and placebo-controlled clinical study to evaluate the efficacy and safety of KaraCalm™: a dietary supplement to support sleep and manage stress

“…16 Previous clinical trials supported the observed effectiveness of KaraCalm™ since all its constituents, Valeriana officinalis extract, Passiflora incarnata extract, Ocimum sanctum extract, Ziziphus jujuba extract, Rosmarinus officinalis extract, and Nigella sativa extract, showed the ability in reducing stress and improving sleep quality in clinical trials. 1,12,13,16,17 Generally, it is known that cortisol secretion is strongly rhythmic and remains at a low level in the day and early night but increases during the latter part of the night towards the morning. Cortisol nadir occurs within 2 hours of sleep onset; this means that sleep initiates when cortisol is lowest and terminates when cortisol is highest.…”

“…The regulation of serum cortisol concentration might be attributed to the presence in the formulation of Rosmarinus officinalis extract and Nigella sativa extract, as previous clinical investigations have demonstrated a decrease in this stress marker. 16,20 Emerging new evidence suggests that sleep may be strongly implicated in cardio-metabolic human health by regulating inflammatory pathways. Previous research has demonstrated a strong connection between sleep deprivation and increased inflammatory biomarkers such as tumour necrosis factor α (TNF-α), interleukin-6 (IL-6), and acute-phase reactant CRP.…”