Overview
Functional Assessment of Ashwagandaha Root Extract During Weight Loss
Status:
Completed
Completed
Trial end date:
2021-06-23
2021-06-23
Target enrollment:
0
0
Participant gender:
All
All
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 qualityPhase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Loma Linda University
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),