Craving, Obesity, Sleep Disturbance, Stress Reaction
Conditions
Brief 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 quality
Detailed description
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
Interventions
DIETARY_SUPPLEMENTAshwagandha Root Extract Capsule
Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.
OTHERPlacebo Capsule
Participants will take one placebo capsule orally twice a day for 12 weeks.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
A designated MD who is not involved in the study design, application, or interpretation will be available to unblind study participants when medically indicated
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale PSS | 12 weeks | Standardized questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index PSQI | 12 weeks | Standardized questionnaire |
| Food Craving Questionnaire - Trait FCQ-T | 12 weeks | Standardized questionnaire |
| Three-Factor Eating Questionnaire TFEQ | 12 weeks | Standardized questionnaire |
Countries
United States
Outcome results
None listed