The Impact of Ashwagandha on Perceived Stress, Sleep and Food Cravings in College Students

June 18, 2022 updated by: Margaret Harris, University of Colorado, Colorado Springs

The Impact of Ashwagandha on Stress, Sleep and Food Cravings in College Students: A Mixed Method Double-blinded Randomized Control Trial

The purpose of this study was to compare the impact of 700 mg daily ashwagandha (Withania Somnifera) in healthy college students on sleep, stress and food cravings to healthy college students taking placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

College aged students tend to report significant daily stress but there is no research on herbal interventions to ameliorate this condition in this population.

This study is a mixed methods, randomized, double blinded, placebo controlled 30 day trial targeting a college aged population. Participants are randomly allocated to either an intervention group (ashwagandha) or a placebo group. Each participant is given a bottle of capsules (capsules look identical but are filled either with a full spectrum dried extract ashwagandha herb or a placebo filled with glycerin). Directions included consuming 1 capsule in the morning and one capsule in the evening. Questionnaires were collected prior to the study and at the end of the study, including an assessment of daily affect. A subset of each group volunteered to attend an intervention specific focus group at 30 days completion of the study.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • University of Colorado Colorado Springs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older
  • Enrolled at the university

Exclusion Criteria:

  • sensitivity to nightshade vegetables;
  • peptic ulcer;
  • pregnant or expected to become pregnant in the near future;
  • breastfeeding;
  • had recent or planned surgery;
  • hypotensive;
  • diagnosed with diabetes;
  • and/or taking any of the following classes of medications: benzodiazepines, central nervous system depressants, diabetes medication, thyroid medication, immune suppressors, cardiovascular medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ashwagandha
Generic name: ashwagandha root extract Dose form: Chloroform capsule Dose: 1 capsule 350 mg ashwagandha root extract Frequency: 2 times per day (one capsule in the morning, one capsule in the evening). Total: 700 mg ashwagandha root extract per day Duration: 30 days
Dietary supplement: Ashwagandha
Intervention and placebo group each received a bottle of 60 capsules. Subjects were instructed to take one capsule in the morning and 1 capsule in the evening. Intervention group was getting 350 mg ashwagandha root extract per capsule (or 700 mg per day). Each intervention capsule delivered 2.5 mg withanolides with equivalence of 2,700 mg dry herb.
Other Names:
  • Withania somnifera
  • Gaia Herbs
Placebo Comparator: Placebo
Generic name: placebo Dose form: Glycerin equivalent weight to ashwagandha Dose: 1 capsule Frequency: one capsule, 2 times per day (one capsule in morning and one in evening) Duration: 30 dys
Other: Placebo
The Placebo group received the same type of bottle with similar looking capsules. Each person in the placebo group was instructed to take 1 capsule twice a day (2 capsules total). Capsules were filled with glycerin to the same weight as ashwagandha. Capsules were indistinguishable from each other.
Other Names:
  • glycerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of ashwagandha on Sleep
Time Frame: Change of restorative sleep quality at 30 days
Restorative Sleep Questionnaire is a 9-item validated scale assessing feelings and experiences about the participant's sleep and their perception of daytime consequences associated with their sleep patterns. Scores range from 0-100 where higher scores indicate better quality sleep.
Change of restorative sleep quality at 30 days
Impact of ashwagandha on Perceived Stress
Time Frame: Change of perceived stress at 30 days
Stress was assessed using the Perceived Stress Scale a 10-item validated questionnaire measuring the degree to which situations in participant's life were viewed as stressful. Questions addressed anxious thoughts, locus of control, and coping mechanisms. Scores range from 0-40 (higher scores indicate higher stress levels).
Change of perceived stress at 30 days
Impact of ashwagandha on Food Cravings
Time Frame: Change of food cravings at 30 days
Eating behavior was assessed using the Food Cravings Questionnaire, a 15-item validated instrument assessing food behavior and appetite using Likert-scales related to intentions for eating, perceived control, hunger cues, emotional states, and guilt associated with cravings. Scores range between 15 and 90 (higher scores indicate more frequent and intense food cravings).
Change of food cravings at 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative analysis of ashwagandha on college students across sleep, stress and food cravings.
Time Frame: At 30 days
A virtual focus group conducted with each intervention group separately and was recorded via a video conferencing platform. Transcript was downloaded and investigators read for thematic analysis.
At 30 days
Daily check in qualitative analysis
Time Frame: Up to 30 days
Participants checked in via Microsoft Teams private chat with a daily question "How are you doing today?" Transcripts were downloaded and analyzed using a qualitative analysis software for coding and thematic analysis
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Colorado Springs

Investigators

  • Principal Investigator: Margaret Harris, PhD, University of Colorado, Colorado Springs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2019

Primary Completion (Actual)

April 10, 2020

Study Completion (Actual)

April 10, 2020

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

June 18, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 18, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19-132

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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