Clinical Trial

Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers

Study acronym: CIRCAFENOL
Recruiting
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Record status
This record was last updated August 27, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
Summary
The physiological processes of the body present daily oscillations called circadian rhythm. The circadian rhythm is essential for maintaining the vital functions of organisms, intervening directly and indirectly in a multitude of key processes, such as hormone secretion, cycles of activity and rest throughout the day, body temperature, the metabolism or absorption, processing and detoxification of nutrients. There are factors such as certain work schedules, prolonged exposure to screens, certain eating patterns or social jetlag, which have a negative impact on the circadian rhythm, causing its disruption and favoring the appearance of health alterations. Thus, there is evidence that associates night shift work with a higher incidence of risk factors for developing metabolic syndrome and cardiovascular diseases, including obesity, elevated blood levels of glucose, triglycerides, and low-density lipoprotein cholesterol (LDL-C), as well as lower levels of high-density lipoprotein cholesterol (HDL-C). In addition, disorders in the sleep cycle are associated with the development of hypertension and type 2 diabetes. Several previous studies show that a grape seed proanthocyanidin extract (GSPE) has beneficial effects on different parameters by restoring the circadian rhythm.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-20; most recent amendment 2025-08-26.
Status change: Not Yet Recruiting → Recruiting 2024-10-29
Trial Details
NCT Number NCT06422741
Lead Sponsor Fundació Eurecat
Collaborators: University Rovira i Virgili
Conditions Cardiovascular Diseases, Circadian Rhythm Sleep Disorder, Shift Work Type, Cholesterol Level, High
Enrollment 22 participants
Start Date 2024-10-28
Primary Completion 2026-02 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-08-27