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

University of Colorado, Colorado Springs

Status and phase: Completed; Phase 2

Conditions: Craving; Well Being; Sleep; Stress

Treatments: Other: Placebo; Dietary Supplement: Ashwagandha

Study type: Interventional

Funder types: Other

Identifiers

NCT05430685

19-132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Ashwagandha

Experimental group

Description:

Generic name: ashwagandha root extract Dose form: Chloroform capsule Dose: 1 capsule 350 mg ashwagandha root extract Frequency: 2 times per day (one capsule in the morning, one capsule in the evening). Total: 700 mg ashwagandha root extract per day Duration: 30 days

Treatment:

Dietary Supplement: Ashwagandha

Placebo

Placebo Comparator group

Description:

Generic name: placebo Dose form: Glycerin equivalent weight to ashwagandha Dose: 1 capsule Frequency: one capsule, 2 times per day (one capsule in morning and one in evening) Duration: 30 dys

Treatment:

Other: Placebo