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OpenTrials
Completed

NCT Number: NCT06859879

A Combined Supplementation of Rosemary and Daylily for Enhancing Sleep Quality in Middle-Aged Adults

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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Key information

Conditions

Sleep

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary Supplement: low-dose Rosemary and Daylily extract

Dietary Supplement

Supplement containing Rosemary and Daylily extract

Dietary Supplement: medium-dose Rosemary and Daylily extract

Dietary Supplement

Supplement containing Rosemary and Daylily extract

Dietary Supplement: control

Dietary Supplement

Supplement containing placebo

Primary outcomes

  1. Total sleep time

    Time frame: Change from baseline total sleep time at 8 weeks

    Total sleep time measured with actigraph monitor

Secondary outcomes

  1. Melatonin

    Time frame: Change from baseline serum melatonin at 8 weeks

    Level of serum melatonin in serum

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Acronym: RESTORE-ENG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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