Loma Linda, California 92350

  • Obesity

Purpose:

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


Study summary:

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


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),


NCT ID:

NCT03112824


Primary Contact:

Principal Investigator
Warren R Peters, MD MPH
LLU Administrator

Peter Bastian, MD
Phone: 909-558-4920
Email: pbastian@llu.edu


Backup Contact:

Email: kbruhjell@llu.edu
Kristin M Bruhjell, BS
Phone: 909-558-4920


Location Contact:

Loma Linda, California 92350
United States

Warren R Peters, MD MPH
Phone: 909-558-8736
Email: wpeters@llu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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