90 NATURALS
Study designs In vitro research In vitro studies were conducted to determine the mechanisms of action behind BSO’s remarkable benefits for ageing skin (Figure 1). A variety of human cell lines were used
to evaluate B’utyQuin’s in vitro effects on markers of mitochondrial activity including ATP production (Figure 2), antioxidant activity, inflammation, and mitochondrial biogenesis (Figure 3). In vitro research utilising a human adipocyte cell line (3T3-L1) also evaluated BSO’s effect on size and composition changes (Figure 4). The results demonstrated that BSO boosted
mitochondrial function and ATP production, significantly inhibited nitric oxide production, and inhibited inflammation. It also activates Sirtuin1, a so-called ‘master regulator’ of mitochondrial biogenesis involved in the cellular response to inflammatory, metabolic, and oxidative stressors. Research elucidated BSO’s beneficial and
powerful effect on uncoupling protein 1 (UCP1), and PRDM16, key regulators of mitochondrial biogenesis and thermogenesis. It also positively impacted Fibroblast Growth Factor 21 (FGF21), a hormone involved in mitochondrial energy production and important metabolic pathways, and heme-oxygenase-1 (HO-1), a protective antioxidant enzyme that prevents cellular apoptosis. BSO’s beneficial effect on mitochondrial
revitalization and cellular hydration in established in vitro models of human skin health was followed by clinical research to establish the safety, compatibility, and efficacy of BSO as a topical anti-ageing cosmetic support for human skin.11,12
Clinical research A single-centre, randomised, blinded, placebo- controlled trial was conducted with 22 healthy male and female subjects, aged 35-65 years with all types of skin. All subjects were compliant with the non-inclusion criteria. The trial duration was 28 days and subjects received samples of both standardised topical containing the active cream and a placebo cream. All subjects applied both the active cream and the placebo, one on each half of the
50 45 40 35 30 25 20 15 10 5 0
Naïve
43% **
26.2% *
25% *
Figure 1: Mechanism of action elucidation behind B’utyQuin - black seed oil with 3% thymoquinone
face. Products were attributed for half-face applications (left/right) to the subjects in a randomised manner. Subjects were assessed at baseline and 28
days via individual daily observation sheets, questionnaires, physical skin examination, photography, and measurements by dermatologists. The active cream was found to be completely safe and compatible with all skin types of study participants. The efficacy of the active cream and
the placebo was assessed using a variety of standard dermatological examination techniques and equipment. These evaluations determined the degree of change in skin firmness and elasticity (Cutometer), hydration (Corneometer), skin color and luminosity (Chromameter CR-400), and general skin appearance (standardized images VISIA-CA) over the course of the 28-day study.
NAC 1mM 0.00014 BQ%
Figure 2: The effect of BSO with 3% thymoquinone (BQ) on production of ATP in Keratinocytes (HaCaT cells) compare to baseline (naïve cells) and positive control (N-Acetylcysteine (NAC) 1mM)
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Measurable skin change efficacy The application of the active cream presented an 11.2% improvement in skin firmness after 28 days of application, compared to only 5.5% firmness improvement with the placebo cream (Figure 5A). The application of the active cream over the course of the study also presented a 6.8% increase in skin elasticity, compared to
only a 1% improvement in elasticity with the placebo (Figure 5B). In addition, the active cream presented a
22.2% increase from baseline in skin hydration after 28 days of application compared to a 14.3 % increase with the placebo cream (Figure 6A). After 28 days of application, the active cream also presented a 1.1% increase in skin luminosity compared to a 1.5% decrease in skin luminosity with the placebo (Figure 6B).
Research highlights In vitro research on cold-pressed, black seed oil standardized to 3% thymoquinone (BSO) had previously elucidated a variety of mechanisms centred around its antioxidant and anti-inflammatory activities and promoting the revitalization of mitochondrial biogenesis. This clinical trial utilising the topical active cream with 3% B’utyQuin validates the mechanisms established with in vitro research by demonstrating the beneficial effects observed in the skin of trial participants. The most significant finding of our
clinical trial is the determination that topical application of a cream containing 3% B’utyQuin specifically improves multiple characteristics of ageing skin – hydration, elasticity, firmness, and luminosity – in a statistically significant,
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ATP Production % Difference from Naïve
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