StressPhase 2NCT05430685
The Impact of Ashwagandha on Perceived Stress, Sleep and Food Cravings in College Students
A Phase 2 study testing Ashwagandha in people with Stress and Sleep, run by University of Colorado, Colorado Springs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Ashwagandha
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 10 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Enrolled at the university
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Colorado Springs
Colorado Springs, Colorado, 80918
About this study
Official title: The Impact of Ashwagandha on Stress, Sleep and Food Cravings in College Students: A Mixed Method Double-blinded Randomized Control Trial
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.
Read the 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.
- Conditions
- Stress, Sleep, Craving, Well Being
- Being tested
- Ashwagandha, Placebo
- Keywords
- Ashwagandha
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AshwagandhaDietary supplement
Also called Gaia Herbs, Withania somnifera
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.
PlaceboOther
Also called glycerin
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.
| Study group | Role | What they receive |
|---|---|---|
| Ashwagandha | Experimental | 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 Receives: Dietary Supplement: Ashwagandha |
| Placebo | Placebo comparator | 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Change of food cravings at 30 days
Secondary outcomes (2)
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.
Measured: 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
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start29 May 2019
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: one intervention, one placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Harris, University of Colorado, Colorado Springs
- Investigators
- Margaret Harris, PhD, Principal investigator, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430685
- Sponsor's protocol ID
- 19-132
- Status last verified
- Jun 2022
- First submitted
- 27 May 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35984871Baker 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.
PubMed 35984870
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ashwagandha on Stress, Sleep and Food Cravings in College Students: A Mixed Method Double-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05430685
- Acronym / sponsor ID
- 19-132
- Conditions
- Stress, Sleep, Craving, Well Being
- Keywords
- Ashwagandha
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: one intervention, one placebo
| Arm | Type | Receives |
|---|---|---|
| Ashwagandha | Experimental | Dietary Supplement: AshwagandhaGeneric 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 |
| Placebo | Placebo comparator | Other: PlaceboGeneric 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Enrolled at the university
Key exclusion criteria (8 listed)
- sensitivity to nightshade vegetables;
- peptic ulcer;
- pregnant or expected to become pregnant in the near future;
- breastfeeding;
- had recent or planned surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AshwagandhaAlso: Gaia Herbs, Withania somniferaIntervention 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. | Dietary supplement | Ashwagandha |
| PlaceboAlso: glycerinThe 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 | Placebo |
Primary outcome
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.
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).
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).
2 secondary outcomes
Qualitative analysis of ashwagandha on college students across sleep, stress and food cravings.
Time frame: At 30 days
Daily check in qualitative analysis
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Derived from this study: PubMed 35984871O'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.
- Derived from this study: PubMed 35984870Baker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Harris, PhD principal investigator
University of Colorado, Colorado Springs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ashwagandha in people with Stress and Sleep, run by University of Colorado, Colorado Springs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of ashwagandha on Sleep (time frame: Change of restorative sleep quality at 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430685, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.