Ashwagandha Extract for Weight and Stress Management in Overweight and Obese Adults

NCT07215455 | Completed

• 1 other identifier: Ixoreal-Weight-CT-03-23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the effects of KSM-66 Ashwagandha root extract (300 mg daily) on weight management and stress reduction in overweight and obese adults. Ashwagandha (Withania somnifera) is a traditional herbal supplement that may help reduce stress and support overall health. In this randomized, double-blind, placebo-controlled trial, participants will receive either Ashwagandha extract or a placebo for the study duration. The main goal is to measure changes in body weight and stress levels. Other health outcomes, such as body mass index (BMI), waist circumference, and quality of life, will also be assessed. The study will help determine whether Ashwagandha is effective and safe for managing stress and supporting weight loss in adults with overweight or obesity.

Conditions

Weight Management; Stress

Outcome Measures

Primary Outcomes (1)

• Mean change in body weight and BMI

  Change from baseline in body weight (kg) and body mass index (BMI, kg/m²) will be assessed in overweight and obese adult participants at Week 4 and Week 12. Measurements will be performed using standardized calibrated equipment under consistent conditions at each visit.

  aseline (Visit 1/Screening/Enrolment), Week 4 (Visit 2), Week 12 (Visit 3/End of Study)

Secondary Outcomes (12)

• Mean change in Perceived Stress Scale (PSS-10) score

  Baseline, Week 4, Week 12

• Mean change in SF-12 Health Survey score

  Baseline, Week 4, Week 12

• Mean change in SSS (Stress Symptom Scale) score

  Baseline, Week 4, Week 12

• Mean change in Food Cravings Questionnaire-Trait (FCQ-T) score

  Baseline, Week 4, Week 12

• Mean change in Complete Blood Count (CBC)

  Baseline, Week 4, Week 12

Study Arms (2)

Treatment Arm 1: KSM-66 capsules containing Ashwagandha 300 mg standardized root extract.

ACTIVE COMPARATOR

Ashwagandha 300 mg root extract in a dose of 300 mg capsules orally twice daily after breakfast and dinner with a glass of water or milk for 12 weeks.

Dietary Supplement: Ashwagandha 300 mg standardized root extract

Treatment Arm 2: Identical placebo capsule.

PLACEBO COMPARATOR

Identical Placebo in a dose of 300 mg capsules orally twice daily after breakfast and dinner with a glass of water or milk for 12 weeks.

Other: Identical placebo capsule.

Interventions

Ashwagandha 300 mg standardized root extract DIETARY_SUPPLEMENT

Participants in this group will receive KSM-66 Ashwagandha, a standardized root extract of Withania somnifera, 300 mg once daily in capsule form. KSM-66 is a high-concentration, full-spectrum extract of Ashwagandha root, designed to provide adaptogenic effects for stress reduction and support weight management. Participants will be instructed to take the capsule with water, preferably at the same time each day, for the duration of the 8-week study. Adherence will be monitored via pill counts and participant diaries.

Treatment Arm 1: KSM-66 capsules containing Ashwagandha 300 mg standardized root extract.

Identical placebo capsule. OTHER

Participants in this group will receive an identical placebo capsule that matches the appearance, size, color, and taste of the KSM-66 Ashwagandha capsule but contains inactive ingredients. The placebo is administered once daily for 8 weeks. Participants will be instructed to take the capsule with water, preferably at the same time each day. Adherence will be monitored via pill counts and participant diaries. The use of a placebo allows comparison with the Ashwagandha group to evaluate efficacy and safety outcomes while maintaining blinding for participants and study staff.

Treatment Arm 2: Identical placebo capsule.

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult men and women participants ≥ 19 years and ≤65 years of age.
• Willingness to follow the protocol requirements as evidenced by written informed consent.
• Participants willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
• Participants who agree to take investigational product (i.e., Till Week 8).
• Participants with Body mass index between 25 and 39.9 kg/m2

You may not qualify if:

• History of Alcohol or smoking abuse.
• History of hypersensitivity to Ashwagandha
• Taking nutritional or energy supplements, medication, or steroids,
• Any history of drug abuse
• Having any clinical abnormalities
• Simultaneously participating in any other clinical trial or participated in the past three months
• Participants who use medication for blood pressure, use beta-blockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks
• Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression.
• Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
• Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania.
• Patients with post traumatic disorder.
• Have an established practice of meditation (as meditating for at least 20 minutes, three or more times per week) for three or more months.
• Pregnant and lactating women
• Participation in other clinical trials during previous 3 months
• Any clinical condition, according to the investigator which does not allow safe fulfilment of clinical trial protocol.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

Location

MeSH Terms

Interventions

Ashwagandha

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 10, 2025
• Study Start: June 17, 2025
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)