Effects of Ashwagandha Extract on Stress Levels

NCT06793891 | Recruiting

• 1 other identifier: 24-09-900
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

energy; fatigue; cognition; nutraceuticals; Ashwagandha

Outcome Measures

Primary Outcomes (2)

• Post-test Cortisol Awakening Response, after controlling for baseline scores

  salivary cortisol levels will be taken immediately after waking and 30 minutes later to produce a composite score

  60 days

• NRI-SS (Nutraceuticals Research Institute's Stress Scale)

  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.

  60 days

Secondary Outcomes (3)

• NRI-ES (Nutraceuticals Research Institute's Energy Scale)

  60 days

• NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale)

  60 days

• NRI-Cognition Scale

  60 days

Study Arms (3)

Plant Extract 1

EXPERIMENTAL

Participants in this arm will take an ashwagandha root supplement each day for 60 days.

Dietary Supplement: ashwagandha root

Plant Extract 2

EXPERIMENTAL

Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days.

Dietary Supplement: ashwagandha root and leaf

Placebo

PLACEBO COMPARATOR

Participants in this arm will take an inert placebo each day for 60 days.

Other: placebo

Interventions

ashwagandha root DIETARY_SUPPLEMENT

This substance is extracted from the root of the plant.

Plant Extract 1

ashwagandha root and leaf DIETARY_SUPPLEMENT

This substance is extracted from both the root and leaves of the plant.

Plant Extract 2

placebo OTHER

The inert placebo does not contain any of the plant matter.

Placebo

Eligibility Criteria

• Age: 30 Years - 59 Years
• Gender Eligibility Details: biological sex of woman; gender identification of female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead

Study Sites (1)

Nutraceuticals Research Institute

Huntsville, Alabama, 35801, United States

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessie Hawkins, PhD

CONTACT

256-203-9010; j.hawkins@nutraceuticalsresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: October 21, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)