Functional Assessment of Ashwagandaha Root Extract During Weight Loss

NCT03112824 | Completed DMC

• 1 other identifier: #5170083
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Stress Reaction; Sleep Disturbance; Craving; Obesity

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale PSS

  Standardized questionnaire

  12 weeks

Secondary Outcomes (3)

• Pittsburgh Sleep Quality Index PSQI

  12 weeks

• Food Craving Questionnaire - Trait FCQ-T

  12 weeks

• Three-Factor Eating Questionnaire TFEQ

  12 weeks

Study Arms (2)

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

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

Placebo Capsule OTHER

Participants will take one placebo capsule orally twice a day for 12 weeks.

Placebo Capsule

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Center for Health Promotion

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Fractures, Stress; Parasomnias; Obesity

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Warren R Peters, MD MPH

  LLU Administrator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A designated MD who is not involved in the study design, application, or interpretation will be available to unblind study participants when medically indicated
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: October 5, 2017
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)