Botanical extract for nonrestorative sleep
A Prospective, Randomized, Double Blind, Placebo Controlled Study To Evaluate The Effects Of Ashwagandha (Withania Somnifera,Ws) Root Plus Leaf Aqueous Extract On Quality Of Sleep In Subjects With Non-Restorative
This study will see if taking one of three daily doses of a botanical extract for eight weeks helps adults who regularly wake up unrefreshed sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kerry Group P.L.C Industry-sponsored |
| Locations | 1 site (Cork) |
| Trial ID | NCT07085819 on ClinicalTrials.gov |
What this trial studies
Adults 18–65 with self-reported nonrestorative sleep will be assigned to take 125 mg, 250 mg, 500 mg of the botanical extract, or placebo daily for eight weeks. Participants will attend four clinic visits, receive three follow-up phone calls, and complete sleep questionnaires and actigraphy monitoring to measure sleep quality and daytime attention. Key eligibility includes an RSQ-W score ≤50 and TSH within the specified range, and pregnant or breastfeeding people are excluded. The study compares changes in subjective sleep symptoms and objective sleep measures between each extract dose and placebo.
Who should consider this trial
Good fit: Adults aged 18–65 who routinely experience unrefreshing sleep despite adequate sleep duration, are generally healthy, and meet screening criteria (including RSQ-W and TSH ranges) are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, outside the 18–65 age range, with other diagnosed sleep disorders or uncontrolled medical conditions, or who cannot attend visits in Cork are unlikely to benefit from participating.
Why it matters
Potential benefit: If effective, the extract could help people with nonrestorative sleep wake feeling more refreshed and improve daytime focus.
How similar studies have performed: Previous trials of botanical remedies for sleep have produced mixed and often modest results, so this approach is plausible but not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Be able to give written informed consent.
2. Be between 18 and 65 years, inclusive.
3. Self-reported unrefreshing sleep despite sufficient sleep duration for at least three nights a week over a one-month period.
4. Have a RSQ-W total score of ≤50 at screening.
5. TSH values between 0.27 - 4.20 miU/L
6. Is in general good health, as determined by the investigator.
7. Willing to consume the Study Product daily for the duration of the study.
Exclusion Criteria:
1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
1. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
2. Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
3. Sexual partner(s) is/are exclusively female.
4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
5. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
3. Has a score ≥10 on Patient Health Questionnaire 8 item (PHQ-8)
4. Has a score ≥10 on Athens Insomnia Scale (AIS)
5. Participants at a high risk of sleep apnoea as determined by Berlin questionnaire/Score \>5 for sleep apnoea.
6. High caffeine intake, \>400mg/day
7. Has a history of drug and/or alcohol abuse at the time of enrolment.
8. Has food allergies or other issues with foods that would preclude intake of the Study Products.
9. Is an active smoker or user of nicotine products, or with a history of cigarettes smoking, tobacco or nicotine product use in the last 6 months.
10. Has undertaken shift work within the last three months or plans to undertake shift work during the study.
11. Travel across three time zones in the two months prior to screening or plans to travel across time zones during intervention.
12. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
1. Diagnosed gastrointestinal disease.
2. Respiratory disorders
3. Seizure disorders
4. Type 1 or 2 diabetes mellitus
5. Thyroid disorders
6. Uncontrolled hypertension
7. Cardiovascular disease
8. Immunocompromised health conditions
13. Current or recent (in the 12 weeks prior to screening) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
1. Barbiturates, anticonvulsants, benzodiazepines, neuroleptics
2. Hypnotics
3. Melatonin
14. Current or recent (in the 4 weeks prior to screening) use of prohibited nutritional or non-nutritional supplements, including:
1. Herbal sleep aid supplements (St. John's Wort, Ginkgo-biloba, kava kava)
2. Ashwagandha
3. Caffeine supplements
15. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
16. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
Where this trial is running
Cork
- Atlantia Food Clinical Trials Ltd. — Cork, Ireland (Recruiting)
Study contacts
- Principal investigator: Timothy Dinan — Atlantia Clinical Trials LTD.
- Study coordinator: Ruth Blanco, PHD
- Email: ruth.blanco@kerry.com
- Phone: +34 913 80 29 73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.