The Impacts of Ashwagandha Supplementation on Diurnal Cortisol and Stress Among Women

This study will add knowledge about how ashwagandha can impact diurnal cortisol values (at waking, 30 minutes-post waking, and bedtime). This study will also assess the impact of ashwagandha consumption on inflammatory biomarkers and self-reported perceived stress, anxiety, and well-being among females.

• Placebo (Other): Brown Rice Powder
• KSM-66 Ashwagandha (Dietary supplement), also known as withania somnifera, KSM66, KSM-66: 600mg daily KSM-66 Ashwagandha

Primary outcomes

• Diurnal Salivary Cortisol Change from Baseline to ~4 weeks and ~8 weeks [Baseline, ~4 weeks,. ~8weeks]: Saliva swabs from waking, 30 minutes post-waking, and bedtime will be analyzed to compare cortisol levels and diurnal changes across timepoints from baseline to \~4 weeks and \~8 weeks (as corresponding to participants menstrual cycle).
• HRV Change from Baseline to ~4 weeks and ~8 weeks [Baseline, ~4 weeks,. ~8weeks]: Wearable biometric device data will be used to compare heart rate variability (HRV) from baseline to \~4 weeks and \~ 8 weeks (as corresponding to participants menstrual cycle).

Secondary outcomes

• Perceived Stress Scale (PSS) [Baseline, ~4 weeks,. ~8weeks]: Perceived Stress Scale (PSS) data will be used to compare changes from baseline to \~4 weeks and \~ 8 weeks (as corresponding to participants menstrual cycle). Individual scores can range from 0 to 40 with higher scores correlating with higher levels of perceived stress. 0-13: Low Stress 14-26: Moderate Stress 27-40: High Perceived Stress
• Hamilton Anxiety Rating Scale (HAM-A) [Baseline, ~4 weeks,. ~8weeks]: Hamilton Anxiety Rating Scale (HAM-A) data will be used to compare changes from baseline to \~4 weeks and \~ 8 weeks (as corresponding to participants menstrual cycle). Each item is scored on a scale of 0 (not present) to 4 (severe). Total scores range of 0-56. 0-17: Mild severity 18-24: Mild to moderate severity 25-30: Moderate to severe
• Depression Anxiety Stress Scale-21 (DASS21) [Baseline, ~4 weeks,. ~8weeks]: Depression Anxiety Stress Scale-21 (DASS21) data will be used to compare subset scales for depression, anxiety and stress changes from baseline to \~4 weeks and \~ 8 weeks (as corresponding to participants menstrual cycle). DASS21 is a set of three scales designed to measure the emotional states of depression, anxiety and stress. Scores can range from normal to extremely severe for each domain. Each item is scored on a scale of 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).
• World Health Organization-Five Well-Being Index (WHO-5) [Baseline, ~4 weeks,. ~8weeks]: World Health Organization-Five Well-Being Index (WHO-5) data will be used to compare mental wellbeing changes from baseline to \~4 weeks and \~ 8 weeks (as corresponding to participants menstrual cycle). Each item is scored on a scale of 0 (at no time) to 5 (all of the time). Total scores range from 0 to 25. With 0 representing worst possible and 25 representing best possible quality of life.
• Sleep Quality Change from Baseline to ~4 weeks and ~8 weeks [Baseline, ~4 weeks,. ~8weeks]: Wearable biometric device data will be used to compare sleep quality, latency, and duration from baseline to \~4 weeks and \~ 8 weeks (as corresponding to participants menstrual cycle).

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

1. Female, ages 18-45
2. No hormonal birth control
3. Identify as having a regular sleep schedule (eg. sleep by 1am and wake by 9am)
4. Identify as having a regular menstrual period between 27-32 days apart on average
5. PSS score of 14 (moderate stress) or greater
6. No expected changes in stress levels over the next 3 months and agree to not initiate any new stress-reduction behaviors before study start or during the study

Exclusion Criteria:

1. Diagnosed major depressive disorder or generalized anxiety disorder in the last 3 months, any liver, kidney, or thyroid disorder/dysfunction/injury, or diabetes
2. Using any medication related to cortisol or HPA function such as corticosteroids, antidepressants, anti-psychotics, CNS-depressants (benzodiazepines, non-benzodiazepine sedatives, barbiturates, anti-convulsants, anesthetics), thyroid medications, diabetic medications, or immunosuppressants
3. Taken any form of ashwagandha within the last 3 months
4. Daily use of alcohol, nicotine, or other substances
5. Who are pregnant, planning to become pregnant, breastfeeding, or have had a hysterectomy
6. Abnormal liver function test value(s) at screening

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• Julie Croff, PhD, Principal investigator, Oklahoma State University Center for Health Sciences
• Erica Crockett, MPH, Principal investigator, Oklahoma State University Center for Health Sciences