Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers
CIRCAFENOL
1 other identifier
interventional
22
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Oct 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedStudy Start
First participant enrolled
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedAugust 27, 2025
August 1, 2025
1.3 years
May 15, 2024
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in LDL cholesterol levels.
Serum LDL cholesterol levels will be measured by commercial colorimetric kit.
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).
Secondary Outcomes (49)
Change in body weight.
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).
Height.
At week 1.
Change in BMI.
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).
Change in waist circumference.
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).
Change in conicity index.
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).
- +44 more secondary outcomes
Study Arms (2)
grape seed proanthocyanidin extract
EXPERIMENTALParticipants will receive the grape seed proanthocyanidin extract (GSPE) for 6 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive the placebo for 6 weeks.
Interventions
250 mg of product presented in capsule form will be given.
Eligibility Criteria
You may qualify 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 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
You may not qualify 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), 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundació Eurecatlead
- University Rovira i Virgilicollaborator
Study Sites (2)
Eurecat
Reus, Tarragona, 43204, Spain
Fundació EURECAT
Reus, Tarragona, 43204, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoni Caimari Palou, PhD
UTNS (Eurecat, Reus)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2024
First Posted
May 21, 2024
Study Start
October 28, 2024
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share