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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03112824
Other study ID # #5170083
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2017
Est. completion date June 23, 2021

Study information

Verified date January 2023
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 23, 2021
Est. primary completion date June 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Dietary Supplement:
Ashwagandha Root Extract Capsule
Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.
Other:
Placebo Capsule
Participants will take one placebo capsule orally twice a day for 12 weeks.

Locations

Country Name City State
United States Loma Linda University Center for Health Promotion Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Scale PSS Standardized questionnaire 12 weeks
Secondary Pittsburgh Sleep Quality Index PSQI Standardized questionnaire 12 weeks
Secondary Food Craving Questionnaire - Trait FCQ-T Standardized questionnaire 12 weeks
Secondary Three-Factor Eating Questionnaire TFEQ Standardized questionnaire 12 weeks
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