Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06422741

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

Led by Fundació Eurecat · Updated on 2025-08-27

22

Participants Needed

2

Research Sites

65 weeks

Total Duration

On this page

Sponsors

F

Fundació Eurecat

Lead Sponsor

U

University Rovira i Virgili

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 years or older
  • Work rotating night shifts with at least 5 night shifts per month for one year or more
  • No intention to change work shift during the study
  • LDL cholesterol levels between 116 and 190 mg/dL without treatment for hypertension or lipid lowering
  • Signed informed consent
  • Able to read, write, and speak Catalan or Spanish
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) over 30 kg/m2
  • Use of supplements or products that may interfere with the study treatment such as vitamins D, E, C, zinc, selenium, omega-3, polyphenols, or plant extracts
  • Alcohol consumption exceeding 4 standard drinks daily or 28 weekly for men, 2 daily or 17 weekly for women
  • Active smoker
  • Weight loss over 3 kg in the last 3 months
  • Food intolerances or allergies to study products like cellulose or proanthocyanidins
  • Chronic or autoimmune diseases affecting results, such as diabetes, cardiovascular disease, kidney disease, thyroid disorders, gastrointestinal diseases, or cancer
  • Familial hypercholesterolemia
  • Hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
  • Previous cardiovascular disease (heart attack, angina, stroke, or peripheral artery disease)
  • Recent use (within 3 months) of lipid-lowering, antidiabetic, or antihypertensive drugs or supplements affecting lipids or blood pressure
  • Following weight loss or very restrictive diets
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Participation in other clinical trials within 30 days before enrollment
  • Eating or psychiatric disorders
  • Unable to follow study guidelines

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Eurecat

Reus, Tarragona, Spain, 43204

Not Yet Recruiting

2

Fundació EURECAT

Reus, Tarragona, Spain, 43204

Actively Recruiting

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Research Team

A

Antoni Caimari Palou, PhD

CONTACT

A

Anna Crescenti, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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