AUTHOR=Lopresti Adrian L. , Smith Stephen J. , Metse Alexandra P. , Drummond Peter D. 

TITLE=A randomized, double-blind, placebo-controlled trial investigating the effects of an Ocimum tenuiflorum (Holy Basil) extract (HolixerTM) on stress, mood, and sleep in adults experiencing stress

JOURNAL=Frontiers in Nutrition

VOLUME=9

YEAR=2022

URL=https://www.frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.965130

DOI=10.3389/fnut.2022.965130

ISSN=2296-861X

ABSTRACT=<sec><title>Background</title><p>In Ayurveda, <italic>Ocimum tenuiflorum</italic> (Holy Basil) is referred to as “the elixir of life” and is believed to promote longevity and general wellbeing. Although limited, there are clinical trials to suggest <italic>Ocimum tenuiflorum</italic> has anti-stress effects.</p></sec><sec><title>Purpose</title><p>Examine the effects of a standardized <italic>Ocimum tenuiflorum</italic> extract (Holixer<sup>TM</sup>) on subjective and objective measures of stress and sleep quality in adults experiencing stress.</p></sec><sec><title>Study design</title><p>Two-arm, parallel-group, 8-week, randomized, double-blind, placebo-controlled trial. Australian and New Zealand Clinical Trials Registry trial registration number ACTRN12621000609853.</p></sec><sec><title>Methods</title><p>One hundred volunteers aged 18–65 years received either 125 mg of <italic>Ocimum tenuiflorum</italic> twice daily or a placebo. Outcome measures included the Perceived Stress Scale (PSS) (primary outcome measure), Profile of Mood States, Athens Insomnia Scale (AIS), Restorative Sleep Questionnaire, and the Patient-Reported Outcomes Measurement Information System-29. Sleep quality was also assessed using a wrist-worn sleep tracker (Fitbit), and stress changes were examined by measuring between-group differences in hair cortisol and stress responses after exposure to an experiment stress procedure known as the Maastricht Acute Stress Test (MAST).</p></sec><sec><title>Results</title><p>Compared to the placebo, <italic>Ocimum tenuiflorum</italic> supplementation was associated with greater improvements in PSS (<italic>p</italic> = 0.003) and AIS (<italic>p</italic> = 0.025) scores; and at week 8, concentrations in hair cortisol were also lower (<italic>p</italic> = 0.025). Moreover, <italic>Ocimum tenuiflorum</italic> supplementation was associated with a buffered stress responses after exposure to the MAST as demonstrated by significantly lower concentrations in salivary cortisol (<italic>p</italic> = 0.001), salivary amylase (<italic>p</italic> = 0.001), systolic (<italic>p</italic> = 0.010) and diastolic (<italic>p</italic> = 0.025) blood pressure, and subjective stress ratings (<italic>p</italic> &lt; 0.001). <italic>Ocimum tenuiflorum</italic> supplementation was well-tolerated with no reports of major adverse effects.</p></sec><sec><title>Conclusion</title><p>The results from this trial suggest that 8 weeks of supplementation with an <italic>Ocimum tenuiflorum</italic> extract (Holixer<sup>TM</sup>) may reduce objective and subjective measures of stress, and improve subjective measures of sleep quality. However, further research using gold-standard objective sleep measures will be required to substantiate the sleep-related findings.</p></sec><sec><title>Clinical trial registration</title><p><ext-link ext-link-type="uri" xlink:href="https://www.anzctr.org.au/ACTRN12621000609853p.aspx" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.anzctr.org.au/ACTRN12621000609853p.aspx</ext-link>, identifier: ACTRN12621000609853p.</p></sec>