Back to resultsFunctional Assessment of Ashwagandaha Root Extract During Weight Loss
Primary Purpose
Stress Reaction, Sleep Disturbance, Craving
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ashwagandha Root Extract Capsule
Placebo Capsule
Sponsored by
About this trial
This is an interventional other trial for Stress Reaction
Eligibility Criteria
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),
Sites / Locations
- Loma Linda University Center for Health Promotion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ashwagandaha Root Extract Capsule
Placebo Capsule
Arm Description
Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks.
Participants will take one placebo capsule twice a day for 12 weeks.
Outcomes
Primary Outcome Measures
Perceived Stress Scale PSS
Standardized questionnaire
Secondary Outcome Measures
Pittsburgh Sleep Quality Index PSQI
Standardized questionnaire
Food Craving Questionnaire - Trait FCQ-T
Standardized questionnaire
Three-Factor Eating Questionnaire TFEQ
Standardized questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03112824
Brief Title
Functional Assessment of Ashwagandaha Root Extract During Weight Loss
Official Title
Functional Assessment of Ashwagandaha Root Extract During Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
June 23, 2021 (Actual)
Study Completion Date
June 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reaction, Sleep Disturbance, Craving, Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
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
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ashwagandaha Root Extract Capsule
Arm Type
Experimental
Arm Description
Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks.
Arm Title
Placebo Capsule
Arm Type
Placebo Comparator
Arm Description
Participants will take one placebo capsule twice a day for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ashwagandha Root Extract Capsule
Intervention Description
Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo Capsule
Intervention Description
Participants will take one placebo capsule orally twice a day for 12 weeks.
Primary Outcome Measure Information:
Title
Perceived Stress Scale PSS
Description
Standardized questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index PSQI
Description
Standardized questionnaire
Time Frame
12 weeks
Title
Food Craving Questionnaire - Trait FCQ-T
Description
Standardized questionnaire
Time Frame
12 weeks
Title
Three-Factor Eating Questionnaire TFEQ
Description
Standardized questionnaire
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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),
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren R Peters, MD MPH
Organizational Affiliation
LLU Administrator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Center for Health Promotion
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No current plans to share IPD
Learn more about this trial
Functional Assessment of Ashwagandaha Root Extract During Weight Loss
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