Overview
The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.
Description
Participants will take one of two extracts or a placebo every day for 60 days; outcomes of stress, sleep, energy, and cognition will provide information on effectiveness.
Eligibility
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
- Self reported high stress
- Baseline score of above-average stress levels on the NRI-SS
- Biological sex of woman; gender identification of female
- Aged 30 to 59, inclusive
- Good general health as evidenced by medical history and screening
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
- Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion Criteria:
- Pregnancy, trying to conceive, or breastfeeding
- Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year
- Consumes > 8 alcoholic beverages in an average week
- Is a primary caretaker for a child younger than 18 months of age
- Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months
- Consumes any stress aid, medication, diet, or supplement intended to improve stress in any way
- Current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants
- Any liver or kidney disorder
- Known allergic reactions to any components of the intervention
- Positive COVID-19 test within 30 days of the study period
- Recent dramatic weight changes (10% change in body weight in the last 6 months)
- Introducing a new investigational drug or other intervention within 60 days before the start of the study
- Introducing a new lifestyle stress-reduction aid (i.e. physical activity, yoga, etc) within 60 days before the start of the study