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The purpose of this project is to better understand the role of ashwagandha on the stress response and wellbeing among healthy, stressed 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Brown Rice Powder |
|
| KSM-66 Ashwagandha | Experimental | 600mg daily KSM-66 Ashwagandha |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Brown Rice Powder |
| |
| KSM-66 Ashwagandha |
| Measure | Description | Time Frame |
|---|---|---|
| Diurnal Salivary Cortisol Change from Baseline to ~4 weeks and ~8 weeks | 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). | Baseline, ~4 weeks,. ~8weeks |
| HRV Change from Baseline to ~4 weeks and ~8 weeks | 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). | Baseline, ~4 weeks,. ~8weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS) | 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 | Baseline, ~4 weeks,. ~8weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Scientist | Contact | 918-517-6151 | erica.crockett@okstate.edu |
| Name | Affiliation | Role |
|---|---|---|
| Julie Croff, PhD | Oklahoma State University Center for Health Sciences | Principal Investigator |
| Erica Crockett, MPH | Oklahoma State University Center for Health Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32021735 | Background | Salve J, Pate S, Debnath K, Langade D. Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study. Cureus. 2019 Dec 25;11(12):e6466. doi: 10.7759/cureus.6466. | |
| 34838432 | Background | Remenapp A, Coyle K, Orange T, Lynch T, Hooper D, Hooper S, Conway K, Hausenblas HA. Efficacy of Withania somnifera supplementation on adult's cognition and mood. J Ayurveda Integr Med. 2022 Apr-Jun;13(2):100510. doi: 10.1016/j.jaim.2021.08.003. Epub 2021 Nov 25. |
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IPD has not been discussed or decided upon for this study yet.
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| ID | Term |
|---|---|
| C030693 | Ashwagandha |
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| Dietary Supplement |
600mg daily KSM-66 Ashwagandha |
|
|
| Hamilton Anxiety Rating Scale (HAM-A) | 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 | Baseline, ~4 weeks,. ~8weeks |
| Depression Anxiety Stress Scale-21 (DASS21) | 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). | Baseline, ~4 weeks,. ~8weeks |
| World Health Organization-Five Well-Being Index (WHO-5) | 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. | Baseline, ~4 weeks,. ~8weeks |
| Sleep Quality Change from Baseline to ~4 weeks and ~8 weeks | 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). | Baseline, ~4 weeks,. ~8weeks |
| 31517876 | Background | Lopresti AL, Smith SJ, Malvi H, Kodgule R. An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Medicine (Baltimore). 2019 Sep;98(37):e17186. doi: 10.1097/MD.0000000000017186. |
| 34858513 | Background | Gopukumar K, Thanawala S, Somepalli V, Rao TSS, Thamatam VB, Chauhan S. Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study. Evid Based Complement Alternat Med. 2021 Nov 30;2021:8254344. doi: 10.1155/2021/8254344. eCollection 2021. |
| 27055824 | Background | Choudhary D, Bhattacharyya S, Joshi K. Body Weight Management in Adults Under Chronic Stress Through Treatment With Ashwagandha Root Extract: A Double-Blind, Randomized, Placebo-Controlled Trial. J Evid Based Complementary Altern Med. 2017 Jan;22(1):96-106. doi: 10.1177/2156587216641830. Epub 2016 Apr 6. |
| 23439798 | Background | Chandrasekhar K, Kapoor J, Anishetty S. A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian J Psychol Med. 2012 Jul;34(3):255-62. doi: 10.4103/0253-7176.106022. |