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

Sponsor
University of Colorado, Colorado Springs (Other)
Overall Status
Completed
CT.gov ID
NCT05430685
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
10.4
Actual Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ashwagandha
  • Other: Placebo
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups: one intervention, one placeboTwo groups: one intervention, one placebo
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The company (Gaia Herbs) prepared the intervention and placebo and had knowledge with Intervention A and B. Neither the investigators, coordinators, subjects or data analyst had knowledge of the group designation.
Primary Purpose:
Treatment
Official Title:
The Impact of Ashwagandha on Stress, Sleep and Food Cravings in College Students: A Mixed Method Double-blinded Randomized Control Trial
Actual Study Start Date :
May 29, 2019
Actual Primary Completion Date :
Apr 10, 2020
Actual Study Completion Date :
Apr 10, 2020

Arms and Interventions

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:
  • Gaia Herbs
  • Withania somnifera

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Impact of ashwagandha on Sleep [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.

    2. Impact of ashwagandha on Perceived Stress [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).

    3. Impact of ashwagandha on Food Cravings [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).

    Secondary Outcome Measures

    1. Qualitative analysis of ashwagandha on college students across sleep, stress and food cravings. [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.

    2. Daily check in qualitative analysis [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Colorado Springs Colorado Springs Colorado United States 80918

    Sponsors and Collaborators

    • University of Colorado, Colorado Springs

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Margaret Harris, Associate Professor, University of Colorado, Colorado Springs
    ClinicalTrials.gov Identifier:
    NCT05430685
    Other Study ID Numbers:
    • 19-132
    First Posted:
    Jun 24, 2022
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Margaret Harris, Associate Professor, University of Colorado, Colorado Springs
    Ashwagandha

    Study Results

    No Results Posted as of Jun 24, 2022