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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Eurecat

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • grape seed proanthocyanidin extract

    Dietary supplement

    250 mg of product presented in capsule form will be given.

  • Placebo

    Dietary supplement

    165 mg of cellulose will be given presented in capsule form.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: grape seed proanthocyanidin extractExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in LDL cholesterol levels.

Serum LDL cholesterol levels will be measured by commercial colorimetric kit.

Time frame
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).

Secondary outcomes

1

Change in body weight.

Body weight will be measured by standardized method.

Time frame
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).
2

Height.

Height will be measured by standardized method.

Time frame
At week 1.
3

Change in BMI.

Weight and height will be combined to report BMI in kg/m\^2.

Time frame
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).
4

Change in waist circumference.

Waist circumference will be measured using a measuring tape.

Time frame
Before (baseline) and after treatment period (6 weeks) for each of the two treatments (GSPE and placebo).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundació Eurecat

Lead sponsor

University Rovira i Virgili

Collaborator