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

Launched by FUNDACIÓ EURECAT · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special extract from grape seeds, called grape seed proanthocyanidin extract (GSPE), can help lower LDL cholesterol levels in people who work rotating night shifts. Night shift work can disrupt the body's natural daily rhythms, which may lead to health issues such as higher cholesterol and increased risk of heart disease. The study aims to see if GSPE can improve cholesterol levels for these workers, ultimately promoting better heart health.

To participate, individuals must be at least 18 years old, have been working night shifts for at least a year, and have specific LDL cholesterol levels without currently taking cholesterol-lowering medications. Participants should not be significantly overweight, should not consume excessive alcohol, and should not have certain health conditions like diabetes or heart disease. If eligible, participants will be asked to take the grape seed extract and monitor their cholesterol levels during the study. This trial could potentially provide valuable insights into managing cholesterol for those affected by the challenges of shift work.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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 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 familial hypercholesterolemia.
• • Present hypertension (Systolic ≥140 mmHg; Diastolic ≥90 mmHg)
• • 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.
• • 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.
• • 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.
• • Suffering from eating disorders or psychiatric disorders.
• • Being unable to follow study guidelines.