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

N/ANot Yet RecruitingNCT07647081

Oklahoma State University Center for Health Sciences30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Stress

Interventions

PlaceboOTHER

Brown Rice Powder

KSM-66 AshwagandhaDIETARY_SUPPLEMENT

600mg daily KSM-66 Ashwagandha

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: Baseline, ~4 weeks,. ~8weeks

Secondary Outcomes

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

Time frame: Baseline, ~4 weeks,. ~8weeks

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

Time frame: 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).

Central Contacts

Research Scientist

CONTACT

918-517-6151 erica.crockett@okstate.edu

Data from ClinicalTrials.gov

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