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

NCT07215455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-06

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • SF Research Institute, Inc.

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2025-10-22
Completion
2025-10-22

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215455 on ClinicalTrials.gov