Sleep
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDietary Supplement: low-dose Rosemary and Daylily extract
Supplement containing Rosemary and Daylily extract
DIETARY_SUPPLEMENTDietary Supplement: medium-dose Rosemary and Daylily extract
Supplement containing Rosemary and Daylily extract
DIETARY_SUPPLEMENTDietary Supplement: control
Supplement containing placebo
Sponsors
University of Novi Sad, Faculty of Sport and Physical Education
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 50 years * Trouble falling asleep \> 5 times a month (NHANES criteria) * Body mass index 18.5-29.9 kg/m2 * Free of major chronic diseases or acute disorders * Given written informed consent
Exclusion criteria
* History of dietary supplement use \> 2 weeks before the study commences * Abnormal values for lab clinical chemistry (\> 2 SD) * Unwillingness to return for follow-up analysis * Participation in other clinical trials * Moderate-to-heavy use of alcohol (\> 3 drinks per week)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total sleep time | Change from baseline total sleep time at 8 weeks | Total sleep time measured with actigraph monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Melatonin | Change from baseline serum melatonin at 8 weeks | Level of serum melatonin in serum |
| Pittsburgh Sleep Quality Index (PSQI) | Change from baseline PSQI at 8 weeks | 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. |
Countries
Serbia
Outcome results
None listed