Functional Assessment of Ashwagandaha Root Extract During Weight Loss
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Obesity Weight Loss, Orthopedic |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/1/2019 |
| Start Date: | October 5, 2017 |
| End Date: | December 2020 |
| Contact: | Peter Bastian, MD |
| Email: | pbastian@llu.edu |
| Phone: | 909-558-4920 |
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
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
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
baseline measurements and final measurements of blood for selected adipokines , cytokines,
and telomerase measurements
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),
We found this trial at
1
site
24785 Stewart Street
Loma Linda, California 92350
Loma Linda, California 92350
Phone: 909-558-8736
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