Functional Assessment of Ashwagandaha Root Extract During Weight Loss

Obesity Clinical Trial

Official title:

Functional Assessment of Ashwagandaha Root Extract During Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112824
• Other study ID #: #5170083
• Status: Completed
• Phase: N/A
• 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
• 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),

Related Conditions & MeSH terms

• Craving
• Dyssomnias
• Fractures, Stress
• Obesity
• Parasomnias
• Sleep Disturbance
• Stress Reaction
• Weight Loss

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