Functional Assessment of Ashwagandaha Root Extract During Weight Loss

• Sponsor: Loma Linda University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03112824
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Stress Reaction; Sleep Disturbance; Craving; Obesity	Drug: Ashwagandha Root Extract Capsule; Drug: Placebo Capsule	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: If the PSS score is than 20, those patients who are interested in participating are consented to the Ashwagandha study. The patients will then be randomized in a double-blind fashion to receive a 31 day supply of study capsules which will be either Ashwagandha 300mg twice a day or identical placebo capsules in a 1:1 ratio. They will be given careful directions into the use of the study capsules and will be asked to mark a daily log (See addendum #3: Treatment Log) of taking the capsules in the morning and at night.If the PSS score is than 20, those patients who are interested in participating are consented to the Ashwagandha study. The patients will then be randomized in a double-blind fashion to receive a 31 day supply of study capsules which will be either Ashwagandha 300mg twice a day or identical placebo capsules in a 1:1 ratio. They will be given careful directions into the use of the study capsules and will be asked to mark a daily log (See addendum #3: Treatment Log) of taking the capsules in the morning and at night.
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: A designated MD who is not involved in the study design, application, or interpretation will be available to unblind study participants when medically indicated
• Primary Purpose: Treatment
• Official Title: Functional Assessment of Ashwagandaha Root Extract During Weight Loss
• Actual Study Start Date: Oct 5, 2017
• Actual Primary Completion Date: Jun 23, 2021
• Actual Study Completion Date: Jun 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ashwagandaha Root Extract Capsule Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks.	Drug: 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.	Drug: Placebo Capsule; Participants will take one placebo capsule orally twice a day for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Perceived Stress Scale PSS [12 weeks]

   Standardized questionnaire

Secondary Outcome Measures

1. Pittsburgh Sleep Quality Index PSQI [12 weeks]

   Standardized questionnaire

2. Food Craving Questionnaire - Trait FCQ-T [12 weeks]

   Standardized questionnaire

3. Three-Factor Eating Questionnaire TFEQ [12 weeks]

   Standardized questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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),

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Center for Health Promotion	Loma Linda	California	United States	92350

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: Warren R Peters, MD MPH, LLU Administrator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT03112824
• Other Study ID Numbers: #5170083
• First Posted: Apr 13, 2017
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Weight Loss; Fractures, Stress

Study Results

No Results Posted as of Nov 10, 2021