Functional Assessment of Ashwagandaha Root Extract During Weight Loss

Study Overview
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Brief Summary
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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
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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

Official Title
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Functional Assessment of Ashwagandaha Root Extract During Weight Loss

Conditions
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Stress Reaction, Sleep Disturbance, Craving, Obesity

Intervention / Treatment
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* Dietary Supplement: Ashwagandha Root Extract Capsule
* Other: Placebo Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: 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 Exclusion Criteria: 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 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),

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ashwagandaha Root Extract Capsule<br>Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks. | Dietary Supplement: Ashwagandha Root Extract Capsule<br>* Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.<br>|
| Placebo Comparator: Placebo Capsule<br>Participants will take one placebo capsule twice a day for 12 weeks. | Other: Placebo Capsule<br>* Participants will take one placebo capsule orally twice a day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale PSS | Standardized questionnaire | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index PSQI | Standardized questionnaire | 12 weeks | 
| Food Craving Questionnaire - Trait FCQ-T | Standardized questionnaire | 12 weeks | 
| Three-Factor Eating Questionnaire TFEQ | Standardized questionnaire | 12 weeks |