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

University of Novi Sad, Faculty of Sport and Physical Education

Status: Completed

Conditions: Sleep

Treatments: Dietary Supplement: Dietary Supplement: medium-dose Rosemary and Daylily extract; Dietary Supplement: Dietary Supplement: control; Dietary Supplement: Dietary Supplement: low-dose Rosemary and Daylily extract

Study type: Interventional

Funder types: Other

Identifiers

NCT06859879

51-02-18

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 3 patient groups, including a placebo group

Experimental 1: Low-dose

Experimental group

Description:

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

Treatment:

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

Experimental 2: Medium-dose

Experimental group

Description:

Two capsules of active Rosemary and Daylily extract

Treatment:

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

Experimental 3: Control

Placebo Comparator group

Description:

Two capsules of placebo

Treatment:

Dietary Supplement: Dietary Supplement: control