Ashwagandha for Aging

Overseen By Amala Soumyanath, PhD

Age: 65+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Oregon Health and Science University

Disqualifiers: Cancer, Diabetes, Cardiovascular, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a supplement called Shoden, derived from the Ashwagandha plant, is absorbed and processed in the bodies of healthy older adults. Participants will receive different doses of Shoden to observe the body's reaction to each. It targets individuals 65 and older who are generally healthy and willing to stop taking other botanical supplements during the study. As an Early Phase 1 trial, this research focuses on understanding how Shoden works in people, offering participants the opportunity to be among the first to receive this treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must stop all botanical supplements for one week before and during the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that Ashwagandha, also known as Withania somnifera, is generally safe to use. One study found that taking Ashwagandha root extract for 12 months did not harm the liver or kidneys. Another study showed that using Ashwagandha for 8 weeks was safe for both men and women.

While most research suggests Ashwagandha is well-tolerated, more information is needed to fully understand its safety. This trial tests a supplement called Shoden in different doses. As an early-phase trial, researchers focus on how the body handles the treatment. So far, no major safety concerns have emerged, but ongoing studies will help confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for aging, which might include lifestyle changes and supplements like fish oil or vitamin D, Shoden is a unique treatment derived from Ashwagandha, an herb traditionally used in Ayurvedic medicine. Researchers are excited about Shoden because it focuses on enhancing the body's resilience to stress, potentially offering rejuvenating effects that other supplements don't target. The treatment is available in different doses—240 mg and 480 mg—allowing for flexibility in addressing individual needs, which is not commonly seen in traditional aging treatments.

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

Research has shown that Ashwagandha, particularly its extract Shoden, may offer several health benefits. This trial will compare two dosages of Shoden, 240 mg and 480 mg, to assess its effects on aging. Studies have found that Shoden can reduce stress and anxiety by lowering morning cortisol levels, a hormone related to stress. Ashwagandha might also enhance physical abilities like strength and endurance, improving overall health. Some research suggests it could support telomerase activity, helping cells stay healthy and live longer. While these findings are promising, further research is needed to fully understand Ashwagandha's impact on aging. ^{1 6 7 8 9}

Who Is on the Research Team?

Alex Speers, ND

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 65 and older with a BMI between 17-35, good vision and hearing, no major health issues or psychiatric disorders, not currently pregnant or trying to conceive, non-smokers, and without allergies to nightshade plants. Participants must be willing to stop taking botanical supplements one week before the study.

Inclusion Criteria

Willingness to attend all study visits

No known sensitivity to Withania somnifera or any of its derivatives

Normal or clinically not significant 12-lead electrocardiogram (ECG) recording

Exclusion Criteria

I have a condition like Alzheimer's, vascular dementia, normal pressure hydrocephalus, or Parkinson's disease.

Participants who are currently pregnant, actively trying to conceive a child, or planning to within three months of study completion

Participation in drug research study within 90 days of screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pharmacokinetics Study Visit

Participants attend a 13-hour pharmacokinetics study visit, receive a single dose of Shoden®, and return for 24- and 48-hour blood and urine collections

2 days

3 visits (in-person)

Treatment

Participants continue taking Shoden® at the administered dose (120 or 240 mg) for four weeks

4 weeks

1 visit (in-person) at the end of 4 weeks

Washout

A two-week washout period between study periods

2 weeks

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

• Shoden

Trial Overview

The study tests how well two doses (240 mg and 480 mg) of Shoden, an Ashwagandha extract supplement, are absorbed and processed in the body when taken orally by older adults. It aims to understand the bioavailability of its compounds.

How Is the Trial Designed?

Group I: Shoden 240 mg Experimental Treatment 1 Intervention

Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Forty-eight hours later, participants will receive a 35-day supply of Shoden at a dose of 240 mg per day.

Group II: Shoden 480 mg Active Control 1 Intervention

Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Forty-eight hours later, participants will receive a 35-day supply of Shoden at a dose of 480 mg per day.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

A study using DNA barcoding on 103 market samples of Ashwagandha found that 77% were authentic, highlighting significant issues with botanical adulteration, especially in powdered forms.

Among the non-authentic samples, 82% were mixed with other plant species, indicating a need for stricter quality control to ensure the medicinal benefits of Ashwagandha are not compromised.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Authentication of the market samples of Ashwagandha by DNA barcoding reveals that powders are significantly more adulterated than roots. Amritha, N., Bhooma, V., Parani, M.[2021]

A randomized, double-blind study with 56 participants showed that a lotion containing 8% Ashwagandha root extract significantly improved skin conditions in photoaged individuals, with a 74.69% reduction in total physician assessment scores compared to 48.68% for the placebo.

The Ashwagandha lotion also led to greater improvements in skin hydration, transepidermal water loss, and elasticity, while safety profiles were similar between the Ashwagandha and placebo groups, indicating it is a safe and effective option for enhancing skin quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Study of Efficacy and Safety of Ashwagandha (Withania somnifera) Lotion on Facial Skin in Photoaged Healthy Adults. Narra, K., Naik, SK., Ghatge, AS.[2023]

A 90-day study on Wistar rats found that KSM-66 Ashwagandha Root Extract (ARE) was safe at doses up to 2000 mg/kg body weight/day, establishing this as the no observed adverse effect level (NOAEL).

The study involved comprehensive assessments of toxicity, including clinical signs, body weight, food consumption, and organ health, indicating that KSM-66 ARE does not pose significant health risks at the tested doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ninety-day repeated dose toxicity of Ashwagandha (Withania somnifera) root extract in Wistar rats. Kalaivani, P., Siva, R., Gayathri, V., et al.[2023]

In a double-blind, randomized, placebo-controlled study involving 130 healthy adults, taking a daily 300 mg capsule of Ashwagandha root extract for 90 days significantly improved memory recall and reduced stress levels, as indicated by lower scores on the Perceived Stress Scale (PSS-10).

Participants taking Ashwagandha SR also reported better sleep quality and overall psychological well-being, with no adverse events noted, highlighting its safety and efficacy as a stress-reducing intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study. Gopukumar, K., Thanawala, S., Somepalli, V., et al.[2022]

In a study involving 18 healthy volunteers, ashwagandha (WS) was well-tolerated at escalating doses over 30 days, with only one participant experiencing mild adverse effects, indicating its safety for use.

The study showed significant improvements in muscle strength and a trend towards reduced body fat percentage, suggesting that ashwagandha may enhance physical performance and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers. Raut, AA., Rege, NN., Tadvi, FM., et al.[2021]

A systematic review of five clinical studies suggests that Withania somnifera (Ashwagandha) may improve cognitive function in various populations, including older adults with mild cognitive impairment and individuals with mental health disorders.

The studies indicate that Ashwagandha supplementation is well tolerated, showing good adherence and minimal side effects, making it a promising option for managing cognitive dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical use of Withania somnifera (Ashwagandha) to ameliorate cognitive dysfunction. Ng, QX., Loke, W., Foo, NX., et al.[2020]

In a randomized, double-blind, placebo-controlled study involving 80 healthy adults, Ashwagandha root extract (300 mg twice daily for 8 weeks) was found to be safe, with no significant adverse effects or changes in vital signs, hematological, or biochemical parameters.

The study supports the traditional use of Ashwagandha in Ayurvedic medicine, indicating it can be consumed safely by both males and females, although further research is needed to explore long-term effects and different dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers. Verma, N., Gupta, SK., Tiwari, S., et al.[2021]

A study assessed the safety of a hydromethanolic extract of the whole plant of Withania somnifera (Ashwagandha) in Sprague Dawley rats, finding it safe at doses up to 1000 mg/kg/day over 28 days.

This research supports the potential use of whole plant extracts, including leaves, for therapeutic applications, as no toxic effects were observed, aligning with the need for further efficacy and safety profiling of leaf-based products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Withania somnifera (L.) Dunal whole-plant extract demonstrates acceptable non-clinical safety in rat 28-day subacute toxicity evaluation under GLP-compliance. Balkrishna, A., Sinha, S., Srivastava, J., et al.[2022]

A 12-week study involving 50 elderly participants (ages 65-80) found that Ashwagandha root extract significantly improved quality of life, sleep quality, and mental alertness compared to a placebo, with a notable increase in WHOQOL-BREF scores.

The Ashwagandha treatment was well-tolerated and considered safe by participants, indicating its potential as an effective supplement for enhancing general well-being in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Ashwagandha Root Extract in the Elderly for Improvement of General Well-being and Sleep: A Prospective, Randomized, Double-blind, Placebo-controlled Study. Kelgane, SB., Salve, J., Sampara, P., et al.[2020]

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This study measures the bioavailability and pharmacokinetics of a Withania somnifera supplement in older adults, using a crossover design with two doses and ...

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

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Ashwagandha - Uses, Side Effects, and More

Learn more about Ashwagandha uses, effectiveness, possible side effects, interactions, dosage, user ratings and products that contain Ashwagandha.

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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.