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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
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.
University of Colorado Colorado Springs
Colorado Springs, Colorado, United States
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.
Time frame: Change of restorative sleep quality at 30 days
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).
Time frame: Change of perceived stress at 30 days
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).
Time frame: Change of food cravings at 30 days
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.
Time frame: At 30 days
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
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Time frame: Up to 30 days