Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers With Moderate Hypercholesterolemia. Randomized, Crossover, Controlled and Triple Blind Study.(CIRCAFENOL)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Men and women aged 18 years or older.

• Follow a rotating night shift work schedule\* for at least one year before the start of the study.

• \* shift workers with at least 5 night shifts per month alternating with day and/or afternoon shifts, with a seniority equal to or greater than one year.

• Have no intention of changing the work shift during the course of the study.

• Circulating LDL-C levels between 116 -190 mg/dL\*, without pharmacological treatment with antihypertensives and/or lipid-lowering agents.

• \*Values of 116 to 190 mg/dl indicate moderate alteration in the lipid profile and a greater risk of suffering from cardiovascular diseases, according to the European Society of Cardiology, and the European Society of Atherosclerosis.

• Have signed the informed consent before starting the study.

• Know how to read, write and speak in Catalan or Spanish

Locations
Other Locations
Spain
Eurecat
NOT_YET_RECRUITING
Reus
Fundació EURECAT
RECRUITING
Reus
Contact Information
Primary
Antoni Caimari Palou, PhD
antoni.caimari@eurecat.org
0034 977 300 805
Backup
Anna Crescenti, PhD
anna.crescenti@eurecat.org
0034 977 300 431
Time Frame
Start Date: 2024-10-28
Estimated Completion Date: 2026-02
Participants
Target number of participants: 22
Treatments
Experimental: grape seed proanthocyanidin extract
Participants will receive the grape seed proanthocyanidin extract (GSPE) for 6 weeks.
Placebo_comparator: Placebo
Participants will receive the placebo for 6 weeks.
Sponsors
Leads: Fundació Eurecat
Collaborators: University Rovira i Virgili

This content was sourced from clinicaltrials.gov