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CompletedNCT06859879RESTORE-ENGUpdated Jan 2, 2026

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

An interventional study of Dietary Supplement: low-dose Rosemary and Daylily extract and Dietary Supplement: medium-dose Rosemary and Daylily extract in Sleep, sponsored by University of Novi Sad, Faculty of Sport and Physical Education. Completed at 1 site in Serbia. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by University of Novi Sad, Faculty of Sport and Physical Education · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Sleep
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In context

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts 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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Experimental 1: Low-dose

    One capsule of active Rosemary and Daylily extract and one placebo capsule

    Dietary Supplement: Dietary Supplement: low-dose Rosemary and Daylily extract

  • Experimental
    Experimental 2: Medium-dose

    Two capsules of active Rosemary and Daylily extract

    Dietary Supplement: Dietary Supplement: medium-dose Rosemary and Daylily extract

  • Placebo comparator
    Experimental 3: Control

    Two capsules of placebo

    Dietary Supplement: Dietary Supplement: control

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

06

What researchers measure

Primary outcomes

  1. Total sleep time

    Total sleep time measured with actigraph monitor

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

Secondary outcomes

  1. Melatonin

    Level of serum melatonin in serum

    Time frame: Change from baseline serum melatonin at 8 weeks

  2. 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.

    Time frame: Change from baseline PSQI at 8 weeks

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Study locations

1 site
  • Applied Bioenergetics Lab at Faculty of Sport and PE
    Novi Sad, Vojvodina 21000, Serbia
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06859879
Lead sponsor
University of Novi Sad, Faculty of Sport and Physical Education
Responsible party
Sergej Ostojic (Professor, University of Novi Sad, Faculty of Sport and Physical Education) — Principal investigator
First posted
Mar 5, 2025
Start date
Apr 15, 2025
Primary completion
Nov 30, 2025
Completion
Dec 15, 2025
Last update
Jan 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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