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This study aims to investigate the impact of supplementation with two different doses of Rosemary and Daylily herbal extract on various health outcomes in middle-aged adults. Over an eight-week period, the trial will assess improvements in sleep quality, circadian rhythms, energy metabolism, and relevant biochemical markers. The study employs a randomized, placebo-controlled, crossover design to evaluate the efficacy of these supplements in enhancing overall health and well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1: Low-dose | Experimental | One capsule of active Rosemary and Daylily extract and one placebo capsule |
|
| Experimental 2: Medium-dose | Experimental | Two capsules of active Rosemary and Daylily extract |
|
| Experimental 3: Control | Placebo Comparator | Two capsules of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: low-dose Rosemary and Daylily extract | Dietary Supplement | Supplement containing Rosemary and Daylily extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time | Total sleep time measured with actigraph monitor | Change from baseline total sleep time at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Melatonin | Level of serum melatonin in serum | Change from baseline serum melatonin at 8 weeks |
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-report tool used to assess sleep quality and disturbances. It consists of 19 items covering seven components: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, daytime dysfunction, and use of sleep medications. Each component is scored from 0 to 3, with higher scores indicating worse sleep quality. The total score ranges from 0 to 21, where a score of 5 or higher suggests poor sleep quality. The PSQI is widely used in clinical and research settings to evaluate sleep health. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Bioenergetics Lab at Faculty of Sport and PE | Novi Sad | Vojvodina | 21000 | Serbia |
Data obtained through this study may be provided to qualified researchers with academic interest in sleep medicine. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Only qualified researchers with academic interest in sleep medicine
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| Dietary Supplement: medium-dose Rosemary and Daylily extract | Dietary Supplement | Supplement containing Rosemary and Daylily extract |
|
| Dietary Supplement: control | Dietary Supplement | Supplement containing placebo |
|
| Change from baseline PSQI at 8 weeks |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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