Functional Assessment of Ashwagandaha Root Extract During... | NCT03112824

Studies
Functional Assessment of Ashwagandaha Root Extract During Weight Loss

NCT03112824

Sponsor

Loma Linda University

Status

Completed

Last Update Posted

Jan 30, 2023Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Stress Reaction
Sleep Disturbance
Craving
Obesity

Interventions

Ashwagandha Root Extract Capsule
Placebo Capsule

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2017Actual

Primary Completion Date

Jun 23, 2021Actual

Completion Date

Jun 23, 2021Actual

First Submitted Date

Apr 10, 2017

First Submission Date that Met QC Criteria

Apr 12, 2017

First Posted Date

Apr 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2023

Last Update Posted Date

Jan 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ashwagandaha Root Extract Capsule	Experimental	Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks.	Dietary Supplement: Ashwagandha Root Extract Capsule
Placebo Capsule	Placebo Comparator	Participants will take one placebo capsule twice a day for 12 weeks.	Other: Placebo Capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ashwagandha Root Extract Capsule	Dietary Supplement	Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.	Ashwagandaha Root Extract Capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perceived Stress Scale PSS	Standardized questionnaire	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pittsburgh Sleep Quality Index PSQI	Standardized questionnaire	12 weeks
Food Craving Questionnaire - Trait FCQ-T	Standardized questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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),

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Warren R Peters, MD MPH	LLU Administrator	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University Center for Health Promotion		Loma Linda	California	92350	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No current plans to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D015775	Fractures, Stress
D020447	Parasomnias
D009765	Obesity

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

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.