Functional Assessment of Ashwagandaha Root Extract During Weight Loss

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

Study Overview

• Status: Completed
• Conditions: Obesity; Sleep Disturbance; Craving; Stress Reaction
• Intervention / Treatment: Dietary supplement: Ashwagandha Root Extract Capsule; Other: Placebo Capsule

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University Center for Health Promotion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ashwagandaha Root Extract Capsule; Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks.	Dietary supplement: Ashwagandha Root Extract Capsule; Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.
Placebo Comparator: Placebo Capsule; Participants will take one placebo capsule twice a day for 12 weeks.	Other: Placebo Capsule; Participants will take one placebo capsule orally twice a day for 12 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Warren R Peters, MD MPH, LLU Administrator

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): June 23, 2021
• Study Completion (Actual): June 23, 2021

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Fractures, Bone; Wounds and Injuries; Body Weight; Body Weight Changes; Dyssomnias; Parasomnias; Weight Loss; Fractures, Stress
• Other Study ID Numbers: #5170083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No current plans to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No