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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05430685
• Other study ID #: 19-132
• Status: Completed
• Phase: Phase 2
• Start date: May 29, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: June 2022
• Source: University of Colorado, Colorado Springs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Craving
• Sleep
• Stress
• Well Being

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Colorado Springs	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Colorado Springs

Country where clinical trial is conducted

United States, 

Outcome

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