Stress Clinical Trial
Official title:
The Impact of Ashwagandha on Stress, Sleep and Food Cravings in College Students: A Mixed Method Double-blinded Randomized Control Trial
NCT number | NCT05430685 |
Other study ID # | 19-132 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 29, 2019 |
Est. completion date | April 10, 2020 |
Verified date | June 2022 |
Source | University of Colorado, Colorado Springs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 10, 2020 |
Est. primary completion date | April 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Colorado Springs | Colorado Springs | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Colorado Springs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of ashwagandha on Sleep | 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 | |
Primary | Impact of ashwagandha on Perceived Stress | 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 | |
Primary | Impact of ashwagandha on Food Cravings | 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 | Qualitative analysis of ashwagandha on college students across sleep, stress and food cravings. | 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 | |
Secondary | Daily check in qualitative analysis | 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 |
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