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OpenTrials
Completed

NCT Number: NCT03112824

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

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Key information

Conditions

Stress Reaction Body Weight Craving Fractures, Bone Fractures, Stress Mental Disorders Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Center for Health Promotion

Loma Linda, California, 92350, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria:
  • BMI of 27 kg/m2 with comorbidities or 30 kg/m2 and above
  • Perceived Stress Scale (PSS) score of ≥ 20 at screening
  • Age 18 to 70 years
  • Generally healthy male or female in the judgement of the principal investigator.
  • Able to attend the testing site at CHP.
  • 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)
  • 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.
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Nursing an infant
  • Currently undergoing cancer treatment
  • Untreated hypertension, diabetes or cardiac arrhythmias
  • Dieting to lose weight in the last month
  • 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),

Treatment and study plan

Ashwagandha Root Extract Capsule

Dietary Supplement

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

Placebo capsule

Other

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

Primary outcomes

  1. Perceived Stress Scale PSS

    Time frame: 12 weeks

    Standardized questionnaire

Secondary outcomes

  1. Pittsburgh Sleep Quality Index PSQI

    Time frame: 12 weeks

    Standardized questionnaire

  2. Food Craving Questionnaire - Trait FCQ-T

    Time frame: 12 weeks

    Standardized questionnaire

  3. Three-Factor Eating Questionnaire TFEQ

    Time frame: 12 weeks

    Standardized questionnaire

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2017
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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