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

NCT06859879 | Completed

• 1 other identifier: 51-02-18
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Total sleep time

  Total sleep time measured with actigraph monitor

  Change from baseline total sleep time at 8 weeks

Secondary Outcomes (2)

• Melatonin

  Change from baseline serum melatonin at 8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline PSQI at 8 weeks

Study Arms (3)

Experimental 1: Low-dose

EXPERIMENTAL

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

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

Experimental 2: Medium-dose

EXPERIMENTAL

Two capsules of active Rosemary and Daylily extract

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

Experimental 3: Control

PLACEBO COMPARATOR

Two capsules of placebo

Dietary Supplement: Dietary Supplement: control

Interventions

Dietary Supplement: medium-dose Rosemary and Daylily extract DIETARY_SUPPLEMENT

Supplement containing Rosemary and Daylily extract

Experimental 2: Medium-dose

Dietary Supplement: control DIETARY_SUPPLEMENT

Supplement containing placebo

Experimental 3: Control

Dietary Supplement: low-dose Rosemary and Daylily extract DIETARY_SUPPLEMENT

Supplement containing Rosemary and Daylily extract

Experimental 1: Low-dose

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: April 15, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 15, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Only qualified researchers with academic interest in sleep medicine

Locations

SE (1)