Stress ReactionNCT03112824
Functional Assessment of Ashwagandaha Root Extract During Weight Loss
A study testing Ashwagandha Root Extract Capsule in people with Stress Reaction and Sleep Disturbance, run by Loma Linda University at 1 site in United States.
Trial summary
Patients who are involved in a clinical protocol driven 12 week medical weight loss intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root extract. The study endpoints are primarily the patients self-reported perception of life stress and sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction, Sleep Disturbance, Craving
- What is being tested?
- Ashwagandha Root Extract Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 23 Jun 2021
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 27 kg/m2 with comorbidities or 30 kg/m2 and above
- Perceived Stress Scale (PSS) score of ≥ 20 at screening
- Age 18 to 70 years
- Generally healthy male or female in the judgement of the principal investigator.
- Able to attend the testing site at CHP.
- Access to a computer and are able to enter information into the computer
Who cannot join
- Exclusion criteria (Justification of exclusion group based on demographics or their vulnerability)
- Taking chronic anti-anxiety, anti-obesity (other than phentermine) or anti-insomnia medication on a regular basis and unwilling to stop taking these classes of medications for the duration of the 12 week trial.
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Show all 14Show fewer
- Nursing an infant
- Currently undergoing cancer treatment
- Untreated hypertension, diabetes or cardiac arrhythmias
- Dieting to lose weight in the last month
- Started within the last 14 days or plan to start taking:
- Birth control pills
- Hormone supplements (Estrogen/Progesterone etc)
- MAO inhibitors, Oral Corticosteroids, Tricyclic antidepressants, SSRI's (except Fluoxetine),
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Center for Health Promotion
Loma Linda, California, 92350
About this study
Patients who are involved in a clinical protocol driven 12 week medical weight loss intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root extract. The study endpoints are primarily the patients self-reported perception of life stress and sleep quality. The working hypothesis of this study is that the addition of aschwagandha to .the medical weight loss program will improve the self-reported perception of life stress and sleep quality
Read the detailed description
During this 12-week medical weight loss program, the randomized patients will also have a baseline measurements and final measurements of blood for selected adipokines , cytokines, and telomerase measurements
- Conditions
- Stress Reaction, Sleep Disturbance, Craving, Obesity
- Being tested
- Ashwagandha Root Extract Capsule, Placebo Capsule
- Medical subject headings
- Fractures, Stress, Parasomnias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ashwagandha Root Extract CapsuleDietary supplement
Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.
Placebo CapsuleOther
Participants will take one placebo capsule orally twice a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ashwagandaha Root Extract Capsule | Experimental | Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks. Receives: Dietary Supplement: Ashwagandha Root Extract Capsule |
| Placebo Capsule | Placebo comparator | Participants will take one placebo capsule twice a day for 12 weeks. Receives: Other: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale PSS
Standardized questionnaire
Measured: 12 weeks
Secondary outcomes (3)
Pittsburgh Sleep Quality Index PSQI
Standardized questionnaire
Measured: 12 weeks
Food Craving Questionnaire - Trait FCQ-T
Standardized questionnaire
Measured: 12 weeks
Three-Factor Eating Questionnaire TFEQ
Standardized questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start5 Oct 2017
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- If the PSS score is than 20, those patients who are interested in participating are consented to the Ashwagandha study. The patients will then be randomized in a double-blind fashion to receive a 31 day supply of study capsules which will be either Ashwagandha 300mg twice a day or identical placebo capsules in a 1:1 ratio. They will be given careful directions into the use of the study capsules and will be asked to mark a daily log (See addendum #3: Treatment Log) of taking the capsules in the morning and at night.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren R Peters, MD MPH, Principal investigator, LLU Administrator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112824
- Sponsor's protocol ID
- #5170083
- Status last verified
- Jan 2023
- First submitted
- 10 Apr 2017
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plans to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment of Ashwagandaha Root Extract During Weight Loss
- ClinicalTrials.gov ID
- NCT03112824
- Acronym / sponsor ID
- #5170083
- Conditions
- Stress Reaction, Sleep Disturbance, Craving, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 13 Apr 2017 (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.
Patients who are involved in a clinical protocol driven 12 week medical weight loss intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root extract. The study endpoints are primarily the patients self-reported perception of life stress and sleep quality. The working hypothesis of this study is that the addition of aschwagandha to .the medical weight loss program will improve the self-reported perception of life stress and sleep quality
Detailed description
During this 12-week medical weight loss program, the randomized patients will also have a baseline measurements and final measurements of blood for selected adipokines , cytokines, and telomerase measurements
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- If the PSS score is than 20, those patients who are interested in participating are consented to the Ashwagandha study. The patients will then be randomized in a double-blind fashion to receive a 31 day supply of study capsules which will be either Ashwagandha 300mg twice a day or identical placebo capsules in a 1:1 ratio. They will be given careful directions into the use of the study capsules and will be asked to mark a daily log (See addendum #3: Treatment Log) of taking the capsules in the morning and at night.
| Arm | Type | Receives |
|---|---|---|
| Ashwagandaha Root Extract Capsule | Experimental | Dietary Supplement: Ashwagandha Root Extract CapsuleParticipants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks. |
| Placebo Capsule | Placebo comparator | Other: Placebo CapsuleParticipants will take one placebo capsule twice a day for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (14 listed)
- Exclusion criteria (Justification of exclusion group based on demographics or their vulnerability)
- Birth control pills
- Hormone supplements (Estrogen/Progesterone etc)
- MAO inhibitors, Oral Corticosteroids, Tricyclic antidepressants, SSRI's (except Fluoxetine),
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 |
|---|---|---|
| Ashwagandha Root Extract CapsuleParticipants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks. | Dietary supplement | Ashwagandaha Root Extract Capsule |
| Placebo CapsuleParticipants will take one placebo capsule orally twice a day for 12 weeks. | Other | Placebo Capsule |
Primary outcome
Perceived Stress Scale PSS
Time frame: 12 weeks
Standardized questionnaire
3 secondary outcomes
Pittsburgh Sleep Quality Index PSQI
Time frame: 12 weeks
Food Craving Questionnaire - Trait FCQ-T
Time frame: 12 weeks
Three-Factor Eating Questionnaire TFEQ
Time frame: 12 weeks
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 30 Jan 2023.
- Individual participant dataSharing planned: No. No current plans to share IPD
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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.
Warren R Peters, MD MPH principal investigator
LLU Administrator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ashwagandha Root Extract Capsule in people with Stress Reaction and Sleep Disturbance, run by Loma Linda University 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 6 inclusion and 14 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 30 Jan 2023. 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.
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?
Perceived Stress Scale PSS (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2023.