Stress
Conditions
Keywords
energy, fatigue, cognition, nutraceuticals, Ashwagandha
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTashwagandha root
This substance is extracted from the root of the plant.
DIETARY_SUPPLEMENTashwagandha root and leaf
This substance is extracted from both the root and leaves of the plant.
OTHERplacebo
The inert placebo does not contain any of the plant matter.
Sponsors
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-test Cortisol Awakening Response, after controlling for baseline scores | 60 days | salivary cortisol levels will be taken immediately after waking and 30 minutes later to produce a composite score |
| NRI-SS (Nutraceuticals Research Institute's Stress Scale) | 60 days | This is a validated scale measuring 6 subdomains of stress. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater stress levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRI-ES (Nutraceuticals Research Institute's Energy Scale) | 60 days | This is a validated scale measuring 6 subdomains of energy. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater energy levels. |
| NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale) | 60 days | This is a validated scale measuring 7 subdomains of sleep. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of sleep |
| NRI-Cognition Scale | 60 days | This is a validated scale measuring 6 subdomains of cognition. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of cognitive health |
Countries
United States
Contacts
Primary ContactJessie Hawkins, PhD
Outcome results
None listed