Ashwagandha Extract for Weight and Stress Management in Overweight and Obese Adults
NCT ID: NCT07215455
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2025-06-17
2025-10-22
Brief Summary
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Detailed Description
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Participants will be randomly assigned to receive either KSM-66 Ashwagandha® capsules or matching placebo capsules for the study duration. Each participant will undergo baseline and follow-up assessments that include anthropometric measurements (body weight, BMI, and waist circumference), psychological evaluations (Perceived Stress Scale and related questionnaires), and laboratory investigations relevant to metabolic and stress-related health.
The study hypothesis is that daily supplementation with KSM-66 Ashwagandha® will lead to a statistically significant reduction in stress levels and body weight compared to placebo. The trial outcomes are expected to contribute to the growing body of evidence supporting the role of Ashwagandha as a safe and natural adaptogenic supplement for weight and stress management in adults.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Arm 1: KSM-66 capsules containing Ashwagandha 300 mg standardized root extract.
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.
Ashwagandha 300 mg standardized root extract
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 2: Identical placebo capsule.
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.
Identical placebo capsule.
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.
Interventions
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Ashwagandha 300 mg standardized root extract
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.
Identical placebo capsule.
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.
Eligibility Criteria
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Inclusion Criteria
2. Willingness to follow the protocol requirements as evidenced by written informed consent.
3. Participants willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
4. Participants who agree to take investigational product (i.e., Till Week 8).
5. Participants with Body mass index between 25 and 39.9 kg/m2
Exclusion Criteria
2. History of hypersensitivity to Ashwagandha
3. Taking nutritional or energy supplements, medication, or steroids,
4. Any history of drug abuse
5. Having any clinical abnormalities
6. Simultaneously participating in any other clinical trial or participated in the past three months
7. 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
8. Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression.
9. Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
10. Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania.
11. Patients with post traumatic disorder.
12. Have an established practice of meditation (as meditating for at least 20 minutes, three or more times per week) for three or more months.
13. Pregnant and lactating women
14. Participation in other clinical trials during previous 3 months
15. Any clinical condition, according to the investigator which does not allow safe fulfilment of clinical trial protocol.
19 Years
65 Years
ALL
Yes
Sponsors
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SF Research Institute, Inc.
NETWORK
Responsible Party
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Locations
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San Francisco Research Institute
San Francisco, California, United States
Countries
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Other Identifiers
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Ixoreal-Weight-CT-03-23
Identifier Type: -
Identifier Source: org_study_id