Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422741
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Effect of a Grape Seed Proanthocyanidin Extract GSPE on LDL Cholesterol Levels in Rotating Night Shift Workers
Sponsor:
Fundació Eurecat
Organization:
Fundació Eurecat
Study Overview
Official Title:
Effect of a Grape Seed Proanthocyanidin Extract GSPE on LDL Cholesterol Levels in Rotating Night Shift Workers With Moderate Hypercholesterolemia Randomized Crossover Controlled and Triple Blind StudyCIRCAFENOL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIRCAFENOL
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
Several previous studies show that a grape seed proanthocyanidin extract GSPE has beneficial effects on different parameters by restoring the circadian rhythm
Detailed Description:
The main objective of the study is to evaluate the effect of daily GSPE intake in combined with dietary recommendations on LDL-C levels in individuals with rotating night shift work
The secondary objectives are to evaluate the effects of GSPE on anthropometric parametersblood pressure heart rate and endothelial function markers of lipid and carbohydrate metabolism and insulin resistance atherogenic indices circulating levels of sex hormones and those related to hunger satiety and stress markers of systemic inflammation circadian rhythm markers and sleep quality level of physical activity energy consumption and changes in gene expression of key metabolic enzymes
A randomized crossover placebo-controlled triple-blind nutritional intervention study will be conducted The study will be carried out in a population of 22 volunteers Men and women aged 18 years or older who are working a rotating night shift for at least 1 year and with blood levels of LDL-C between 116 and 190 mgdL may participate
Each volunteer will make 5 visits to the facilities of the EURECAT Nutrition and Health Technological Unit in accordance with the study design
A pre-selection visit to check inclusionexclusion criteria and if the inclusion criteria are met
Two study visits during consumption of the first product GSPE or placebo which will take place on the first day of study visit 1 and after 6 weeks of treatment visit 2
Two study visits during consumption of the second product GSPE or placebo which will take place after a three-week washout period visit 3 and after 6 weeks of treatment visit 4
The main variable of the CIRCAFENOL study is circulating LDL-C levels
The secondary objectives are to evaluate the effects of GSPE on anthropometric parametersblood pressure heart rate and endothelial function markers of lipid and carbohydrate metabolism and insulin resistance atherogenic indices circulating levels of sex hormones and those related to hunger satiety and stress markers of systemic inflammation circadian rhythm markers and sleep quality level of physical activity energy consumption and changes in gene expression of key metabolic enzymes
A randomized crossover placebo-controlled triple-blind nutritional intervention study will be conducted The study will be carried out in a population of 22 volunteers Men and women aged 18 years or older who are working a rotating night shift for at least 1 year and with blood levels of LDL-C between 116 and 190 mgdL may participate
Each volunteer will make 5 visits to the facilities of the EURECAT Nutrition and Health Technological Unit in accordance with the study design
A pre-selection visit to check inclusionexclusion criteria and if the inclusion criteria are met
Two study visits during consumption of the first product GSPE or placebo which will take place on the first day of study visit 1 and after 6 weeks of treatment visit 2
Two study visits during consumption of the second product GSPE or placebo which will take place after a three-week washout period visit 3 and after 6 weeks of treatment visit 4
The main variable of the CIRCAFENOL study is circulating LDL-C levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None