Weight ManagementNCT07215455
Ashwagandha Extract for Weight and Stress Management in Overweight and Obese Adults
A study testing Ashwagandha 300 mg standardized root extract in people with Weight Management and Stress, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management, Stress
- What is being tested?
- Ashwagandha 300 mg standardized root extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2025to 22 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Research Institute
San Francisco, California, 94132
About this study
Official title: Efficacy And Safety of KSM66 Ashwagandha (Withania Somnifera) Standardized Root Extract (300 mg) on Weight and Stress Management in Overweight and Obese Adults: A Prospective, Randomized, Double-Blind Placebo- Controlled Study
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.
Read the detailed description
This randomized, double-blind, placebo-controlled clinical study is being conducted to investigate the potential efficacy and safety of KSM-66 Ashwagandha® root extract (300 mg per capsule) in promoting weight management and reducing stress in adults classified as overweight or obese.
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
- Weight Management, Stress
- Being tested
- Ashwagandha 300 mg standardized root extract, Identical placebo capsule.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ashwagandha 300 mg standardized root extractDietary 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Identical placebo capsule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change from baseline in PSS-10 scores, measuring perceived stress levels in overweight and obese adult participants, at Week 4 and Week 12.
Measured: Baseline, Week 4, Week 12
Mean change in SF-12 Health Survey score
Change from baseline in SF-12 scores, evaluating physical and mental health-related quality of life in overweight and obese adult participants, at Week 4 and Week 12.
Measured: Baseline, Week 4, Week 12
Mean change in SSS (Stress Symptom Scale) score
Change from baseline in SSS scores, assessing self-reported stress symptoms in overweight and obese adult participants, at Week 4 and Week 12.
Measured: Baseline, Week 4, Week 12
Mean change in Food Cravings Questionnaire-Trait (FCQ-T) score
Change from baseline in FCQ-T scores, evaluating trait-level food cravings in overweight and obese adult participants, at Week 4 and Week 12.
Measured: Baseline, Week 4, Week 12
Mean change in Complete Blood Count (CBC)
Change from baseline in hematological parameters including hemoglobin (g/dL), total leukocyte count (cells/µL), and platelet count (cells/µL) measured by automated hematology analyzer.
Measured: Baseline, Week 4, Week 12
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
All TEAEs and TESAEs occurring during the 12-week intervention period will be recorded and summarized by number and proportion of participants affected, severity, and relationship to study intervention.
Measured: 12-week treatment period
Mean change in Lipid Profile
Change from baseline in serum lipid parameters including total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), and triglycerides (mg/dL) measured by enzymatic colorimetric method.
Measured: Baseline, Week 4, Week 12
Mean change in Liver Function Test (LFT)
Change from baseline in liver function parameters including serum alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), alkaline phosphatase (ALP; U/L), and total bilirubin (mg/dL) measured using automated biochemistry analyzer.
Measured: Baseline, Week 4, Week 12
Mean change in Renal Function Test (RFT)
Change from baseline in renal function parameters including serum creatinine (mg/dL) and blood urea nitrogen (BUN; mg/dL) measured using automated biochemistry analyzer.
Measured: Baseline, Week 4, Week 12
Mean change in Thyroid Function Parameters
Change from baseline in serum Thyroxine (T4; µg/dL), Triiodothyronine (T3; ng/dL), and Thyroid-Stimulating Hormone (TSH; µIU/mL) measured by chemiluminescent immunoassay.
Measured: Baseline, Week 4, Week 12
Mean change in Fasting Blood Sugar (FBS)
Change from baseline in fasting blood glucose level (mg/dL) measured by enzymatic glucose oxidase method.
Measured: Baseline, Week 4, Week 12
Mean change in Glycated Hemoglobin (HbA1c)
Change from baseline in HbA1c (%) measured by high-performance liquid chromatography (HPLC).
Measured: Baseline, Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start17 Jun 2025
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215455
- Sponsor's protocol ID
- Ixoreal-Weight-CT-03-23
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No