NCT06422741

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Fundació Eurecat · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The main objective of the study is to evaluate the effect of daily GSPE intake, in combined with dietary recommendations, on LDL-C levels in individuals with rotating night shift work. The secondary objectives are to evaluate the effects of GSPE on: anthropometric parameters,blood pressure, heart rate and endothelial function, markers of lipid and carbohydrate metabolism and insulin resistance, atherogenic indices, circulating levels of sex hormones and those related to hunger, satiety and stress; markers of systemic inflammation; circadian rhythm markers and sleep quality; level of physical activity, energy consumption, and changes in gene expression of key metabolic enzymes. A randomized, crossover, placebo-controlled, triple-blind nutritional intervention study will be conducted. The study will be carried out in a population of 22 volunteers. Men and women aged 18 years or older, who are working a rotating night shift for at least 1 year and with blood levels of LDL-C between 116 and 190 mg/dL may participate. Each volunteer will make 5 visits to the facilities of the EURECAT Nutrition and Health Technological Unit, in accordance with the study design: * A pre-selection visit (to check inclusion/exclusion criteria), and if the inclusion criteria are met. * Two study visits during consumption of the first product (GSPE or placebo), which will take place on the first day of study (visit 1) and after 6 weeks of treatment (visit 2). * Two study visits during consumption of the second product (GSPE or placebo), which will take place after a three-week washout period (visit 3), and after 6 weeks of treatment (visit 4). The main variable of the CIRCAFENOL study is circulating LDL-C levels.

Conditions

• Cardiovascular Diseases
• Circadian Rhythm Sleep Disorder, Shift Work Type
• Cholesterol Level, High

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	grape seed proanthocyanidin extract	250 mg of product presented in capsule form will be given.
DIETARY_SUPPLEMENT	Placebo	165 mg of cellulose will be given presented in capsule form.

Timeline

• Start date: 2024-10-28
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-05-21
• Last updated: 2025-08-27

Locations

2 sites across 1 country: Spain