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Functional Assessment of Ashwagandaha Root Extract During Weight Loss

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ClinicalTrials.gov Identifier: NCT03112824
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Brief 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. 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

Condition or disease Intervention/treatment Phase
Stress Reaction Sleep Disturbance Craving Obesity Drug: Ashwagandha Root Extract Capsule Drug: Placebo Capsule Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Masking Description: A designated MD who is not involved in the study design, application, or interpretation will be available to unblind study participants when medically indicated
Primary Purpose: Treatment
Official Title: Functional Assessment of Ashwagandaha Root Extract During Weight Loss
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ashwagandaha Root Extract Capsule
Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks.
Drug: Ashwagandha Root Extract Capsule
Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.

Placebo Comparator: Placebo Capsule
Participants will take one placebo capsule twice a day for 12 weeks.
Drug: Placebo Capsule
Participants will take one placebo capsule orally twice a day for 12 weeks.




Primary Outcome Measures :
  1. Perceived Stress Scale PSS [ Time Frame: 12 weeks ]
    Standardized questionnaire


Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index PSQI [ Time Frame: 12 weeks ]
    Standardized questionnaire

  2. Food Craving Questionnaire - Trait FCQ-T [ Time Frame: 12 weeks ]
    Standardized questionnaire

  3. Three-Factor Eating Questionnaire TFEQ [ Time Frame: 12 weeks ]
    Standardized questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria:

    1. BMI of 27 kg/m2 with comorbidities or 30 kg/m2 and above
    2. Perceived Stress Scale (PSS) score of ≥ 20 at screening
    3. Age 18 to 70 years
    4. Generally healthy male or female in the judgement of the principal investigator.
    5. Able to attend the testing site at CHP.
    6. Access to a computer and are able to enter information into the computer

Exclusion Criteria:

  • Exclusion criteria (Justification of exclusion group based on demographics or their vulnerability)

    1. 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.
    2. Adults unable to consent
    3. Individuals who are not yet adults (infants, children, teenagers)
    4. Pregnant women
    5. Prisoners
    6. Nursing an infant
    7. Currently undergoing cancer treatment
    8. Untreated hypertension, diabetes or cardiac arrhythmias
    9. Dieting to lose weight in the last month
    10. 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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112824


Contacts
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Contact: Peter Bastian, MD 909-558-4920 pbastian@llu.edu
Contact: Kristin M Bruhjell, BS 909-558-4920 kbruhjell@llu.edu

Locations
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United States, California
Loma Linda University Center for Health Promotion Recruiting
Loma Linda, California, United States, 92350
Contact: Warren R Peters, MD MPH    909-558-8736    wpeters@llu.edu   
Contact: Linda M Ball, BS RN    909-558-4594    lball@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Warren R Peters, MD MPH LLU Administrator
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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT03112824    
Other Study ID Numbers: #5170083
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plans to share IPD

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Weight Loss
Fractures, Stress
Body Weight Changes
Body Weight
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Fractures, Bone
Wounds and Injuries