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New treatment option for Cardiovascular Diseases
Official title Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers
ClinicalTrials.gov ID: NCT06422741
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- Have signed the informed consent before starting the study.
You likely can't join if
- 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)...
- 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.
See the full eligibility 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...
- 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...
- Have signed the informed consent before starting the study.
- Know how to read, write and speak in Catalan or Spanish
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Reus, Tarragona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reus, Tarragona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.