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| Name | Class |
|---|---|
| Gencor Pacific Limited, Hong Kong | INDUSTRY |
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The goal of this clinical trial is to learn if natural supplements (lavender oil, PEA, and OEA) work to improve sleep and reduce stress in adults with moderate stress levels and sleep difficulties. It will also learn about the safety of these natural supplements.
The main questions it aims to answer are:
Researchers will compare three active treatment groups (lavender oil, PEA, Trpti which contains OEA) to a placebo (a look-alike capsule that contains no active ingredients) to see if these natural supplements work to improve sleep and reduce stress.
Participants will take 1 capsule (either active supplement or placebo) every day for 8 weeks and attend 2 clinic visits with a phone check in in between.
The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial This four-arm, parallel-group trial evaluates bioactive compounds targeting stress-sleep pathophysiology (lavender oil, PEA, and OEA). The 8-week intervention employs validated psychometric instruments alongside salivary biomarkers providing objective HPA axis and circadian rhythm assessment. The trial enrolls 240 participants (60 per arm) with moderate stress (PSS ≥14) and sleep complaints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPO Lavender oil | Experimental | 85mg CPO Lavender oil will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. |
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| Levagen+ PEA | Experimental | 75mg Levagen+ PEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. |
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| Trpti OEA | Experimental | 150mg Trpti OEA will be administered daily, This will be taken as a capsule, 1 capsule daily for 57 days. |
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| Placebo | Placebo Comparator | A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavender Oil | Dietary Supplement | 85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress via Perceived Stress Scale (PSS) | Change from baseline to the end of the study period in Perceived stress via Perceived Stress Scale (PSS). The Perceived Stress Scale is a self-reported tool for measuring psychological stress. A total PSS-10 score from 0 to 40 is presented, with higher scores representing higher levels of stress. | Day 1 to day 57 |
| Anxiety via Beck Anxiety Inventory (BAI) | Change from baseline to the end of the study period in Anxiety via Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report questionnaire evaluating anxiety symptoms, rated on a 4-point scale. | Day 1 to day 57 |
| Sleep quality | Change from baseline to the end of the study period in Sleep quality. This will be measured via Pittsburgh Sleep Quality Index (PSQI) and Consensus Sleep Diary. The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns. | Day 1 to day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Mental wellbeing | Change from baseline to the end of the study period in Mental wellbeing via The World Health Organization-Five Well-Being Index (WHO-5). The WHO-5 is a self-report instrument measuring mental well-being. It consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being. A score ≤ 50 (or < 13 in the raw score) is associated with poor well-being or psychological distress and a score ≤ 28 may denote possible clinical symptoms of depression. |
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Inclusion Criteria:
Generally healthy adults aged 18 and over.
Able to provide informed consent.
Score of at least 14 on the Perceived Stress Scale (PSS).
Those with a sleep complaint with a frequency of at least 2 times per week(1)
Agree not to use other dietary supplements for sleep, depression, stress or anxiety other than the investigational product during entire study period.
Agree not to change current diet and/or exercise frequency or intensity during entire study period.
Agree to not participate in another clinical trial during the study period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Rao, PhD | Contact | +61 (0) 7 3102 4486 | research@rdcglobal.com.au |
| Name | Affiliation | Role |
|---|---|---|
| RV Venkatesh | Gencor Pacific | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Recruiting | Brisbane | Australia |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C045718 | lavender oil |
| C005958 | palmidrol |
| C488250 | oleoylethanolamide |
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| Palmitoylethanolamide (PEA) | Dietary Supplement | 75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days. |
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| Oleoylethanolamide | Dietary Supplement | 150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days |
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| Placebo | Other | A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days. |
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| Day 1 to day 57 |
| Mood | Change from baseline to the end of the study period in Mood via Profile of mood states (POMS). The POMS is a self-reported questionnaire consisting of 65 items, designed to evaluate individuals within seven different mood domains: fatigue-inertia, anger-hostility, vigor-activity, confusion-bewilderment, depression-dejection, tension-anxiety, and friendliness. | Day 1 to day 57 |
| Sleep duration | Change from baseline to the end of the study period in Sleep duration via PSQI and Consensus Sleep Diary. The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns. | Day 1 to day 57 |
| Sleep onset latency | Change from baseline to the end of the study period in Sleep onset latency as measured by duration of time (minutes) from turning light off to falling asleep (PSQI and Consensus Sleep Diary). The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The Consensus Sleep Diary is designed to gather information about daily sleep patterns. | Day 1 to day 57 |
| Sleep efficiency | Change from baseline to the end of the study period in Sleep efficiency as measured by ratio of total sleep time to time in bed (PSQI). The PSQI is a self-report questionnaire used to evaluate overall sleep quality. Each of the 19 items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. | Day 1 to day 57 |
| Daytime sleepiness | Change from baseline to the end of the study period in Daytime sleepiness via Functional Outcomes of Sleep Questionnaire (FOSQ-10). The FOSQ-10 consists of 10 items distributed among 5 subscales i.e. general productivity (2 item), activity level (3 items), vigilance (3 items), social outcomes (1 item) and sexual relationship (1 item). Items are rated on a scale of 1-4 (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, 4 = no difficulty). The total score is the sum of the 5 sub scores. | Day 1 to day 57 |
| Eating in response to experienced stress | Change from baseline to the end of the study period in Eating in response to experienced stress via the Salzburg Stress Eating Scale (SSES). The SSES is a questionnaire use to measure eating in response to experienced stress. The response categories range from 'I eat much less than usual' to 'I eat much more than usual' and are scored on a 5-point Likert scale, i.e., a score from 1 - 5. Higher scores indicate that the respondent eats more when stressed is experienced. | Day 1 to day 57 |
| Serotonin | Change from baseline to the end of the study period in serotonin via saliva test. | Day 1 to day 57 |
| Cortisol | Change from baseline to the end of the study period in cortisol via saliva test. | Day 1 to day 57 |
| Melatonin | Change from baseline to the end of the study period in melatonin via saliva test. | Day 1 to day 57 |
| Safety via AE monitoring | Change from baseline to the end of the study period in Safety via AE monitoring | Day 1 to day 57 |
| Safety via vital signs (blood pressure) | Change from baseline to the end of the study period in safety via vital signs (blood pressure). | Day 1 to day 57 |
| Safety via vital signs (heart rate) | Change from baseline to the end of the study period in safety via vital signs (heart rate). | Day 1 to day 57 |
| Safety via vital signs (O2 saturation) | Change from baseline to the end of the study period in safety via vital signs (O2 saturation). | Day 1 to day 57 |
| Safety via vital signs (temperature) | Change from baseline to the end of the study period in safety via vital signs (temperature). | Day 1 to day 57 |
| D001523 | Mental Disorders |