Craving, Sleep, Stress, Well Being
Conditions
Keywords
Ashwagandha
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.
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.
Interventions
DIETARY_SUPPLEMENTAshwagandha
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.
OTHERPlacebo
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.
Sponsors
University of Colorado, Colorado Springs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Two groups: one intervention, one placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Outcome results
None listed