Functional Assessment of Ashwagandaha Root Extract During Weight Loss

Loma Linda University (LLU)

Status: Completed

Conditions: Stress Reaction; Craving; Obesity; Sleep Disturbance

Treatments: Dietary Supplement: Ashwagandha Root Extract Capsule; Other: Placebo Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03112824

#5170083

Details and patient eligibility

About

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

Full 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

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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),

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

Ashwagandaha Root Extract Capsule

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ashwagandha Root Extract Capsule

Placebo Capsule

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo Capsule