Non Restorative SleepNCT07085819
Sleep Promoting Properties of a Botanical Extract in a Population Complaining From Non-Restorative Sleep (NRS)
A study testing Botanical Extract, 125mg, Botanical Extract, 250mg and Botanical Extract, 500mg in people with Non Restorative Sleep and Sleep Disorder (Disorder), run by Kerry Group P.L.C at 1 site in Ireland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Restorative Sleep, Sleep Disorder (Disorder)
- What is being tested?
- Botanical Extract, 125mg, Botanical Extract, 250mg and Botanical Extract, 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIreland
- Study dates
- 15 Jul 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to give written informed consent.
- Be between 18 and 65 years, inclusive.
- Self-reported unrefreshing sleep despite sufficient sleep duration for at least three nights a week over a one-month period.
- Have a RSQ-W total score of ≤50 at screening.
- TSH values between 0.27 - 4.20 miU/L
- Is in general good health, as determined by the investigator.
- Willing to consume the Study Product daily for the duration of the study.
Who cannot join
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- 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).
- Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
- 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.
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- 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.
- Has a score ≥10 on Patient Health Questionnaire 8 item (PHQ-8)
- Has a score ≥10 on Athens Insomnia Scale (AIS)
- Participants at a high risk of sleep apnoea as determined by Berlin questionnaire/Score >5 for sleep apnoea.
- High caffeine intake, >400mg/day
- Has a history of drug and/or alcohol abuse at the time of enrolment.
- Has food allergies or other issues with foods that would preclude intake of the Study Products.
- 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.
- Has undertaken shift work within the last three months or plans to undertake shift work during the study.
- Travel across three time zones in the two months prior to screening or plans to travel across time zones during intervention.
- 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:
- Diagnosed gastrointestinal disease.
- Respiratory disorders
- Seizure disorders
- Type 1 or 2 diabetes mellitus
- Thyroid disorders
- Uncontrolled hypertension
- Cardiovascular disease
- Immunocompromised health conditions
- 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:
- Barbiturates, anticonvulsants, benzodiazepines, neuroleptics
- Hypnotics
- Melatonin
- Current or recent (in the 4 weeks prior to screening) use of prohibited nutritional or non-nutritional supplements, including:
- Herbal sleep aid supplements (St. John's Wort, Ginkgo-biloba, kava kava)
- Ashwagandha
- Caffeine supplements
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Atlantia Food Clinical Trials Ltd.
Cork, T23 R50R
About this study
Official title: 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
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
- Non Restorative Sleep, Sleep Disorder (Disorder)
- Being tested
- Botanical Extract, 125mg, Botanical Extract, 250mg, Botanical Extract, 500mg, Pacebo
- Keywords
- Sleep quality, Attention, Focus, Actigraph
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botanical Extract, 125mgDietary supplement
Two capsules per day (125 mg/day) before sleep, with or without food, for 8 weeks.
Botanical Extract, 250mgDietary supplement
Two capsules per day (250 mg/day) before sleep, with or without food, for 8 weeks.
Botanical Extract, 500mgDietary supplement
Two capsules per day (500 mg/day) before sleep, with or without food, for 8 weeks
PaceboDietary supplement
Two capsules per day before sleep, with or without food, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Botanical Extract 125 | Experimental | 125 mg Receives: Dietary Supplement: Botanical Extract, 125mg |
| Botanical Extract 250 | Experimental | 250 mg Receives: Dietary Supplement: Botanical Extract, 250mg |
| Botanical Extract 500 | Experimental | 500 mg Receives: Dietary Supplement: Botanical Extract, 500mg |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Pacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep restorative quality
To evaluate the impact of 8 weeks daily supplementation of the Botanical Extract on Non-Restorative Sleep (NRS) as assessed by Restorative Sleep Questionnaire (RSQ-W) score compared to placebo. The total score range from 0-100 with higher scores indicating better restorative sleep.
Measured: 8 weeks
Secondary outcomes (9)
Sleep Quality
To evaluate the impact of 8 weeks daily supplementation with the Botanical Extract compared to placebo on Sleep quality as assessed by Pittsburgh Sleep Quality Questionnaire (PSQI). The total score range from 0 to 21 with the higher score indicating worse sleep quality.
Measured: 8 weeks
Attention-Rapid Visual Information Processing (RVIP)
To evaluate the impact of 8 weeks of daily supplementation with the Botanical Extract compared to a placebo on attention using the Millisecond Rapid Visual Information Processing (RVIP) task. The following metrics will be collected and evaluated: latency (speed of response) probability of false alarms, and sensitivity
Measured: 8 weeks
Attention-Sustained Attention to Response Task (SART).
To evaluate the impact of 8 weeks of daily supplementation with the Botanical Extract compared to a placebo on attention as assessed by the Millisecond Sustained Attention to Response Task (SART). The following metrics will be collected and evaluated: errors of commission, errors of omission, and reaction time.
Measured: 8 weeks
Cognition
To evaluate the impact of 8 weeks daily supplementation with the Botanical Extract compared to placebo on cognition as assessed by Cognitive Function: PROMIS - Abilities-Short Form 8a. The form consists of 8 items, each rated on a 5-point scale from "Never" to "Very often" with higher scores indicating better cognitive function
Measured: 8 weeks
Stress
To evaluate the impact of 8 weeks daily supplementation with the Botanical Extract compared to placebo on stress as assessed by serum cortisol levels (μg/dL).
Measured: 8 weeks
Sleep parameters-Total Sleep Time (TST)
To assess the effect of 8 weeks of daily Botanical Extract supplementation versus placebo on TST(minutes), based on Actigraphy-measured average weekly differences and total change from baseline (Day 0) to Day 56.
Measured: 24-hour wear time for 8 weeks
Sleep Parameters- Wake After Sleep Onset (WASO)
To assess the effect of 8 weeks of daily Botanical Extract supplementation versus placebo on WASO (minutes), based on Actigraphy-measured average weekly differences and total change from baseline (Day 0) to Day 56.
Measured: 24-hour wear time for 8 weeks
Sleep Parameters- Sleep Onset Latency (SOL)
To assess the effect of 8 weeks of daily Botanical Extract supplementation versus placebo on SOL (minutes), based on Actigraphy-measured average weekly differences and total change from baseline (Day 0) to Day 56.
Measured: 24-hour wear time for 8 weeks.
Sleep Parameters- Sleep Efficiency (SE)
To assess the effect of 8 weeks of daily Botanical Extract supplementation versus placebo on SE (%), based on Actigraphy-measured average weekly differences and total change from baseline (Day 0) to Day 56. 24-hour wear time for 8 weeks
Measured: 24-hour wear time for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start15 Jul 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Restorative SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1:1 ratio to receive either a dose of a Botanical Extract or a placebo. Study products will be dispensed by the site according to the randomization scheme during the study visits.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerry Group P.L.C
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Principal investigator, Atlantia Clinical Trials LTD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085819
- Sponsor's protocol ID
- S24-1511769
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07085819
- Acronym / sponsor ID
- S24-1511769
- Conditions
- Non Restorative Sleep, Sleep Disorder (Disorder)
- Keywords
- Sleep quality, Attention, Focus, Actigraph
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kerry Group P.L.CIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned in a 1:1:1:1 ratio to receive either a dose of a Botanical Extract or a placebo. Study products will be dispensed by the site according to the randomization scheme during the study visits.
| Arm | Type | Receives |
|---|---|---|
| Botanical Extract 125 | Experimental | Dietary Supplement: Botanical Extract, 125mg125 mg |
| Botanical Extract 250 | Experimental | Dietary Supplement: Botanical Extract, 250mg250 mg |
| Botanical Extract 500 | Experimental | Dietary Supplement: Botanical Extract, 500mg500 mg |
| Placebo | Placebo comparator | Dietary Supplement: PaceboMaltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be able to give written informed consent.
- Be between 18 and 65 years, inclusive.
- Self-reported unrefreshing sleep despite sufficient sleep duration for at least three nights a week over a one-month period.
- Have a RSQ-W total score of ≤50 at screening.
- TSH values between 0.27 - 4.20 miU/L
Key exclusion criteria (35 listed)
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Has a score ≥10 on Patient Health Questionnaire 8 item (PHQ-8)
- Has a score ≥10 on Athens Insomnia Scale (AIS)
- Participants at a high risk of sleep apnoea as determined by Berlin questionnaire/Score >5 for sleep apnoea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botanical Extract, 125mgTwo capsules per day (125 mg/day) before sleep, with or without food, for 8 weeks. | Dietary supplement | Botanical Extract 125 |
| Botanical Extract, 250mgTwo capsules per day (250 mg/day) before sleep, with or without food, for 8 weeks. | Dietary supplement | Botanical Extract 250 |
| Botanical Extract, 500mgTwo capsules per day (500 mg/day) before sleep, with or without food, for 8 weeks | Dietary supplement | Botanical Extract 500 |
| PaceboTwo capsules per day before sleep, with or without food, for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
Sleep restorative quality
Time frame: 8 weeks
To evaluate the impact of 8 weeks daily supplementation of the Botanical Extract on Non-Restorative Sleep (NRS) as assessed by Restorative Sleep Questionnaire (RSQ-W) score compared to placebo. The total score range from 0-100 with higher scores indicating better restorative sleep.
9 secondary outcomes
Sleep Quality
Time frame: 8 weeks
Attention-Rapid Visual Information Processing (RVIP)
Time frame: 8 weeks
Attention-Sustained Attention to Response Task (SART).
Time frame: 8 weeks
Cognition
Time frame: 8 weeks
Stress
Time frame: 8 weeks
Sleep parameters-Total Sleep Time (TST)
Time frame: 24-hour wear time for 8 weeks
Sleep Parameters- Wake After Sleep Onset (WASO)
Time frame: 24-hour wear time for 8 weeks
Sleep Parameters- Sleep Onset Latency (SOL)
Time frame: 24-hour wear time for 8 weeks.
Sleep Parameters- Sleep Efficiency (SE)
Time frame: 24-hour wear time for 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Dinan principal investigator
Atlantia Clinical Trials LTD.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanical Extract, 125mg, Botanical Extract, 250mg and Botanical Extract, 500mg in people with Non Restorative Sleep and Sleep Disorder (Disorder), run by Kerry Group P.L.C at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Blanco, PHD (+34 913 80 29 73, ruth.blanco@kerry.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep restorative quality (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.