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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Dietary Supplement: control; Dietary supplement: Dietary Supplement: low-dose Rosemary and Daylily extract; Dietary supplement: Dietary Supplement: medium-dose Rosemary and Daylily extract

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Experimental 3: Control; Two capsules of placebo	Dietary supplement: Dietary Supplement: control; Supplement containing placebo
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; Supplement containing 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; Supplement containing Rosemary and Daylily extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time	Total sleep time measured with actigraph monitor	Change from baseline total sleep time at 8 weeks

Secondary Outcome Measures

Outcome Measure	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.	Change from baseline PSQI at 8 weeks

Collaborators and Investigators

• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 27, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: 51-02-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: Only qualified researchers with academic interest in sleep medicine
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No