Functional Assessment of Ashwagandaha Root Extract During Weight Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-05

Study Completion Date

2021-06-23

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

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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

Conditions

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Stress Reaction Sleep Disturbance Craving Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

A designated MD who is not involved in the study design, application, or interpretation will be available to unblind study participants when medically indicated

Study Groups

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Ashwagandaha Root Extract Capsule

Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks.

Group Type EXPERIMENTAL

Ashwagandha Root Extract Capsule

Intervention Type DIETARY_SUPPLEMENT

Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.

Placebo Capsule

Participants will take one placebo capsule twice a day for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type OTHER

Participants will take one placebo capsule orally twice a day for 12 weeks.

Interventions

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Ashwagandha Root Extract Capsule

Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo Capsule

Participants will take one placebo capsule orally twice a day for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

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),

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes