Actively Recruiting
A Prospective, Randomized, Double Blind, Placebo Controlled Study To Evaluate The Effects Of Ashwagandha Extract On Sleep Quality In Adults With Non-Restorative Sleep
Led by Kerry Group P.L.C · Updated on 2025-08-26
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kerry Group P.L.C
Lead Sponsor
A
Atlantia Food Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a Botanical Extract on improving symptoms of nonrestorative sleep (NRS) in healthy adults aged 18 to 65. The main question is whether this Botanical Extract can enhance sleep quality and reduce symptoms of NRS compared to a placebo. The study is a prospective, randomized, double-blind, placebo-controlled trial sponsored by Kerry Group P.L.C. Participants will be randomly assigned to take one of three doses of the Botanical Extract (125 mg, 250 mg, or 500 mg per day) or a placebo daily for 8 weeks. Each dose is given as two capsules before sleep, with or without food. The study includes four clinic visits for checkups and tests, along with three follow-up phone calls during the trial period. During the trial, participants will be monitored for sleep restorative quality as the primary outcome after 8 weeks. Secondary outcomes include overall sleep quality, attention and cognition tests, stress levels, and detailed sleep parameters such as total sleep time, wake time after sleep onset, sleep onset latency, and sleep efficiency using 24-hour wear-time monitoring. Safety and adherence will be assessed through regular visits and phone calls, with total participation lasting 8 weeks.
CONDITIONS
Brief Title
Sleep Promoting Properties of a Botanical Extract in a Population Complaining From Non-Restorative Sleep (NRS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent.
- Aged between 18 and 65 years, inclusive.
- Self-reported unrefreshing sleep at least three nights a week over one month.
- RSQ-W total score of 50 or less at screening.
- TSH levels between 0.27 and 4.20 miU/L.
- In generally good health as determined by the investigator.
- Willing to take the study product daily for the full study duration.
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Of childbearing potential without continuous effective contraception.
- PHQ-8 score of 10 or higher.
- Athens Insomnia Scale score of 10 or higher.
- High risk of sleep apnea (Berlin questionnaire score over 5).
- High caffeine intake over 400 mg/day.
- History of drug or alcohol abuse at enrollment.
- Food allergies or issues preventing intake of study products.
- Active smoker or nicotine user or use within last 6 months.
- Shift work in last three months or planned during study.
- Travel across three time zones in two months before or during study.
- Significant acute or chronic health conditions affecting study participation or results.
- Current or recent use of medications interfering with study objectives or safety.
- Use of prohibited supplements including herbal sleep aids, Ashwagandha, or caffeine supplements within specified timeframes.
- Poor attendance or unlikely to comply with study requirements.
- Participation in other clinical studies without sufficient washout period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take two capsules of botanical extract or placebo daily before sleep for 8 weeks.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
Atlantia Food Clinical Trials Ltd.
Cork, Ireland, T23 R50R
Actively Recruiting
Research Team
R
Ruth Blanco, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here