Ashwagandha for Obesity

Overseen By Dr. John Ademola

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SF Research Institute, Inc.

Must not be taking: Blood pressure meds, Beta-blockers

Disqualifiers: Heart disease, Diabetes, Depression, others

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Ashwagandha, a traditional herbal supplement, can aid in weight loss and stress reduction for overweight or obese adults. Participants will take either Ashwagandha or a placebo to compare effects on body weight, stress levels, and other health indicators such as waist size and quality of life. The study seeks adults with a BMI (a measure of body fat based on height and weight) between 25 and 39.9 who can commit to taking the supplement as directed. As an unphased trial, participants can contribute to valuable research on natural health solutions.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, including those for blood pressure, beta-blockers, inhaled beta-agonists, hormonal contraceptives, corticosteroids, and psychotropic medications, to participate in this trial.

Is there any evidence suggesting that Ashwagandha extract is likely to be safe for humans?

Research has shown that Ashwagandha root extract is generally safe for use. In one study, participants used Ashwagandha for eight weeks without any safety issues. Another study found that taking 600 mg of Ashwagandha daily for a year did not harm the liver or kidneys. These studies suggest that Ashwagandha is well-tolerated and does not cause serious side effects. However, the effects of using it for more than a year remain unclear. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for obesity?

Researchers are excited about Ashwagandha extract for obesity because it offers a natural alternative to traditional treatments like lifestyle changes, medications, or surgery. Unlike conventional options, Ashwagandha is a herbal supplement that may help manage weight by reducing stress and cortisol levels, which are often linked to weight gain. This approach targets the root causes of obesity differently, providing a potentially safer and gentler option for those seeking weight management solutions. Additionally, Ashwagandha's adaptogenic properties could offer broader benefits for overall health and well-being, making it a compelling choice for researchers and patients alike.

What evidence suggests that Ashwagandha might be an effective treatment for obesity?

Research has shown that Ashwagandha root extract can help adults manage weight and reduce stress, particularly under constant stress. Some studies found that Ashwagandha led to positive changes in body composition, improving the balance of fat and muscle. Evidence also indicates it can improve blood fat levels, suggesting it might help lower cholesterol. In this trial, participants will receive either Ashwagandha extract or a placebo to evaluate its potential benefits for weight management and stress reduction. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for overweight and obese adults who are looking to manage their weight and reduce stress. Participants should be interested in trying a traditional herbal supplement, Ashwagandha. Specific inclusion or exclusion criteria details were not provided.

Inclusion Criteria

Participants with Body mass index between 25 and 39.9 kg/m2

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

Exclusion Criteria

History of Alcohol or smoking abuse

Pregnant and lactating women

Participation in other clinical trials during previous 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive KSM-66 Ashwagandha or placebo capsules twice daily for weight and stress management

12 weeks

3 visits (in-person) at Baseline, Week 4, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ashwagandha Extract

Trial Overview

The study tests if Ashwagandha root extract (300 mg daily) helps with weight management and stress reduction compared to a placebo. It's a randomized, double-blind trial where neither the participants nor the researchers know who gets the real supplement or placebo until after the results are collected.

How Is the Trial Designed?

Group I: Treatment Arm 1: KSM-66 capsules containing Ashwagandha 300 mg standardized root extract. Active Control 1 Intervention

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.

Group II: Treatment Arm 2: Identical placebo capsule. Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

SF Research Institute, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07215455

Ashwagandha Extract for Weight and Stress Management ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5871210/

Body Weight Management in Adults Under Chronic Stress ...

The outcome of this study suggests that Ashwagandha root extract can be used for body weight management in adults under chronic stress.

3.

nutritionandmetabolism.biomedcentral.com

nutritionandmetabolism.biomedcentral.com/articles/10.1186/s12986-025-01028-6

Impact of ashwagandha (Withania somnifera L ...

Specifically, Ashwagandha supplementation has been associated with positive changes in body composition metrics, leading to a beneficial ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT07215455/ashwagandha-extract-for-weight-and-stress-management-in-overweight-and-obese-adults

Ashwagandha Extract for Weight and Stress Management ...

This study is designed to evaluate the effects of KSM-66 Ashwagandha root extract (300 mg daily) on weight management and stress reduction ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12595879/

Impact of ashwagandha (Withania somnifera L. ...

Ashwagandha supplementation improved serum lipid profiles in adults with overweight and obesity, suggesting potential lipid-lowering effects ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0965229920319099

Safety of Ashwagandha Root Extract: A Randomized, ...

The present study revealed that the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers.

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/ptr.70096

Safety of 12‐Months Administration of Ashwagandha ...

The Ashwagandha root extract (KSM-66; 600 mg/day) administered orally over 12 months failed to show any deleterious effects on hepatic, renal, ...

8.

webmd.com

webmd.com/vitamins/ai/ingredientmono-953/ashwagandha

Ashwagandha - Uses, Side Effects, and More

When taken by mouth: Ashwagandha is possibly safe when used for up to 3 months. The long-term safety of ashwagandha is not known. Large doses of ashwagandha ...