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

SF Research Institute, Inc.

Status: Completed

Conditions: Stress; Weight Management

Treatments: Other: Identical placebo capsule.; Dietary Supplement: Ashwagandha 300 mg standardized root extract

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07215455

Ixoreal-Weight-CT-03-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult men and women participants ≥ 19 years and ≤65 years of age.
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

1. History of Alcohol or smoking abuse.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Ashwagandha 300 mg standardized root extract

Treatment Arm 2: Identical placebo capsule.

Placebo Comparator group

Description:

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.

Treatment:

Other: Identical placebo capsule.