Clinical trial NCT05430685: The Impact of Ashwagandha on Perceived Stress, Sleep and Food Cravings in College Students
Official title: The Impact of Ashwagandha on Stress, Sleep and Food Cravings in College Students: A Mixed Method Double-blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Sleep
Craving
Well Being
Keywords: Ashwagandha
Lead sponsor: University of Colorado, Colorado Springs
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: one intervention, one placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of ashwagandha on Sleep
timeFrame: Change of restorative sleep quality at 30 days
measure: Impact of ashwagandha on Perceived Stress
timeFrame: Change of perceived stress at 30 days
measure: Impact of ashwagandha on Food Cravings
timeFrame: Change of food cravings at 30 days
Secondary outcomes:
measure: Qualitative analysis of ashwagandha on college students across sleep, stress and food cravings.
timeFrame: At 30 days
measure: Daily check in qualitative analysis
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: University of Colorado Colorado Springs
state: Colorado
Study officials:
affiliation: University of Colorado, Colorado Springs
name: Margaret Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connor J, Lindsay K, Baker C, Kirby J, Hutchins A, Harris M. The Impact of Ashwagandha on Stress, Sleep Quality, and Food Cravings in College Students: Quantitative Analysis of a Double-Blind Randomized Control Trial. J Med Food. 2022 Dec;25(12):1086-1094. doi: 10.1089/jmf.2022.0040. Epub 2022 Aug 18.
citation: Baker C, Kirby JB, O'Connor J, Lindsay KG, Hutchins A, Harris M. The Perceived Impact of Ashwagandha on Stress, Sleep Quality, Energy, and Mental Clarity for College Students: Qualitative Analysis of a Double-Blind Randomized Control Trial. J Med Food. 2022 Dec;25(12):1095-1101. doi: 10.1089/jmf.2022.0042. Epub 2022 Aug 18.