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Completed

NCT Number: NCT05430685

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

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.

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Key information

Conditions

Stress Craving Sleep Well Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Colorado Springs

Colorado Springs, Colorado, 80918, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ashwagandha

Dietary Supplement

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 names: Gaia Herbs, Withania somnifera

Placebo

Other

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.

Other names: glycerin

Primary outcomes

  1. Impact of ashwagandha on Sleep

    Time frame: 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.

  2. Impact of ashwagandha on Perceived Stress

    Time frame: 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).

  3. Impact of ashwagandha on Food Cravings

    Time frame: 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 outcomes

  1. Qualitative analysis of ashwagandha on college students across sleep, stress and food cravings.

    Time frame: 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.

  2. Daily check in qualitative analysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Colorado Springs

Other

Registry information

Official study title

The Impact of Ashwagandha on Stress, Sleep and Food Cravings in College Students: A Mixed Method Double-blinded Randomized Control Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2022
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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