NCT06422741Recruiting
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)
Source: ClinicalTrials.gov · Last updated 27 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 15 May 2024
- Start date
- 28 Oct 2024
- Primary completion date
- Feb 2026
- Lead sponsor
- Fundació Eurecat
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06422741
What you commit to
- Study type: Interventional
- Planned participants: 22
- From 28 Oct 2024 to the primary completion date, Feb 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Present any previous cardiovascular disease defined as myocardial infarction, angina pectoris, stroke or peripheral arterial disease.
- Individuals with treatment in the last 3 months before the start of the study with lipid-lowering, antidiabetic and/or antihypertensive drugs, or other drugs that may interfere with the results of the study.
- Taking supplements with polyphenol components or those aimed at lipid or blood pressure control in the last 3 months before the start of the study or during participation in the study.
- Be participating or have participated in a clinical trial with medications or nutritional intervention study in the last 30 days before inclusion in the study.
Other illness
- Present food intolerances and/or allergies related to the study products, such as hypersensitivity to cellulose or proanthocyanidins.
- Present any chronic or autoimmune disease in clinical manifestation that may affect the results of the study such as diabetes (type I or II), cardiovascular disease, chronic kidney disease, hyper or hypothyroidism, chronic gastrointestinal diseases or cancer.
- Present hypertension (Systolic ≥140 mmHg; Diastolic ≥90 mmHg)
- Suffering from eating disorders or psychiatric disorders.
Other
- BMI values \> 30 kg/m2
- Take supplements, multivitamin supplements (Vit.D, Vit. E and Vit.C), mineral supplements (Zinc, Selenium), essential fatty acids (omega-3), polyphenols, natural plant extracts, or phytotherapeutic products that interfere with the treatment under study.
- Consumption of alcoholic beverages:
- Men: consume 4 or more Standard Beverage Units daily or 28 Standard Beverage Units weekly.
- Women: Consume 2 or more Standard Beverage Units daily or 17 Standard Beverage Units weekly.
- Be an active smoker.
- Having lost more than 3 kg of weight in the last 3 months.
- Present familial hypercholesterolemia.
- Follow a diet to lose weight, or very restrictive types of eating, such as intermittent fasting, ketogenic diet, etc.
- Being pregnant or intending to become pregnant.
- Being breastfeeding.
- Being unable to follow study guidelines.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eurecat Coordinator of this site? Confirm its status | Reus | Spain | Not yet recruiting |
| Fundació Eurecat Coordinator of this site? Confirm its status | Reus | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.