Clinical trial NCT03112824: Functional Assessment of Ashwagandaha Root Extract During Weight Loss
Official title: Functional Assessment of Ashwagandaha Root Extract During Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Reaction
Sleep Disturbance
Craving
Obesity
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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

Eligibility 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),

Primary outcomes:
measure: Perceived Stress Scale PSS
timeFrame: 12 weeks
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index PSQI
timeFrame: 12 weeks
measure: Food Craving Questionnaire - Trait FCQ-T
timeFrame: 12 weeks
measure: Three-Factor Eating Questionnaire TFEQ
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Center for Health Promotion
state: California
Study officials:
affiliation: LLU Administrator
name: Warren R Peters, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: