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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botanical Extract 125 | Experimental | 125 mg |
|
| Botanical Extract 250 | Experimental | 250 mg |
|
| Botanical Extract 500 | Experimental | 500 mg |
|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botanical Extract, 125mg | Dietary Supplement | Two capsules per day (125 mg/day) before sleep, with or without food, for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Attention-Rapid Visual Information Processing (RVIP) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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:
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:
Current or recent (in the 4 weeks prior to screening) use of prohibited nutritional or non-nutritional supplements, including:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth Blanco, PHD | Contact | +34 913 80 29 73 | ruth.blanco@kerry.com |
| Name | Affiliation | Role |
|---|---|---|
| Timothy Dinan | Atlantia Clinical Trials LTD. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials Ltd. | Recruiting | Cork | T23 R50R | Ireland |
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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.
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| Botanical Extract, 250mg | Dietary Supplement | Two capsules per day (250 mg/day) before sleep, with or without food, for 8 weeks. |
|
| Botanical Extract, 500mg | Dietary Supplement | Two capsules per day (500 mg/day) before sleep, with or without food, for 8 weeks |
|
| Pacebo | Dietary Supplement | Two capsules per day before sleep, with or without food, for 8 weeks. |
|
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 |
| 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. | 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 | 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). | 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. | 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. | 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. | 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 | 24-hour wear time for 8 weeks |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| C113841 | PACEBO protocol |
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