Actively Recruiting
Sleep Promoting Properties of a Botanical Extract in a Population Complaining From Non-Restorative Sleep (NRS)
Led by Kerry Group P.L.C · Updated on 2025-08-26
160
Participants Needed
1
Research Sites
19 weeks
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
The goal of this clinical trial is to evaluate the effect of the Botanical Extract in improving sleep symptoms of nonrestorative sleep (NRS) in healthy adults. The main question it aims to answer is • Does the Botanical Extract improve sleep quality and reduce symptoms of nonrestorative sleep (NRS)? Researchers will compare the Botanical Extract to a placebo to see if it works. Participants will: * Take one of 3 doses of the Botanical Extract (125 mg/day, 250mg/day ,500mg/day) or a placebo every day for 8 weeks. * Visit the clinic four times for checkups and tests and receive three follow-up phone calls.
CONDITIONS
Official 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
- Between 18 and 65 years old, inclusive
- Self-reported unrefreshing sleep despite sufficient sleep duration for at least three nights a week over one month
- RSQ-W total score of 50 or less at screening
- TSH values between 0.27 and 4.20 miU/L
- In general good health as determined by the investigator
- Willing to take the study product daily for the study duration
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Biological childbearing potential without effective contraception use
- PHQ-8 score of 10 or higher
- Athens Insomnia Scale score of 10 or higher
- High risk of sleep apnea as per Berlin questionnaire (score >5)
- High caffeine intake over 400 mg/day
- History of drug or alcohol abuse at enrollment
- Food allergies or issues preventing study product intake
- Active smoker or nicotine product user or history within last 6 months
- Shift work within last 3 months or planned during study
- Travel across three time zones in 2 months before screening or planned during intervention
- Significant acute or chronic health conditions including gastrointestinal disease, respiratory disorders, seizure disorders, diabetes, thyroid disorders, uncontrolled hypertension, cardiovascular disease, or immunocompromised conditions
- Use of medications interfering with study objectives or safety within 12 weeks prior, including barbiturates, anticonvulsants, benzodiazepines, neuroleptics, hypnotics, melatonin
- Use of prohibited supplements within 4 weeks prior, including herbal sleep aids (St. John's Wort, Ginkgo-biloba, kava kava), Ashwagandha, caffeine supplements
- Considered likely to be poor attendees or unable to comply
- Participation in other clinical studies without sufficient washout time
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Atlantia Food Clinical Trials Ltd.
Cork, Ireland, T23 R50R
Actively Recruiting
Research Team
R
Ruth Blanco, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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