Overweight and Obesity Clinical Trial
— CARDIOGENEOfficial title:
Impact of the Consumption of (Poly)Phenolic Rich Products on Cardiometabolic Risk Markers in Postmenopausal Women
Verified date | July 2022 |
Source | Universidad de Murcia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this investigation is to test the hypothesis that in post-menopausal women with cardiometabolic risk, eating a relatively high daily amount of (poly)phenol-containing products (green tea, dark chocolate and berries) could reduce the risk of metabolic syndrome and cardiovascular disease. Changes in different biomarkers of lipid metabolism, glucose metabolism, inflammation and oxidative stress will be evaluated. Other related factors may be also affected, such as body mass index (BMI) and the percentage of body fat, dietary habits (total energy intake and macronutrient distribution) and microbiota composition.
Status | Completed |
Enrollment | 26 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 65 Years |
Eligibility | Inclusion Criteria: - Women 45-65 years old - With 12 months of amenorrhea - With overweight or obesity (BMI 25-32) or high percentage of body fat or waist to hip ratio >0.85. - Total cholesterol lower than 240 mg/dL Exclusion Criteria: - Pre-menopausal women - Hormonal therapy and other pharmacological treatment - Less than 12 months of amenorrhea - Smoking women - Endocrine (Diabetes mellitus or others), renal, hepatic, cancer or psychiatric disorders |
Country | Name | City | State |
---|---|---|---|
Spain | Edificio Pleyades-Vitalys 5ª y 6ª planta | Murcia |
Lead Sponsor | Collaborator |
---|---|
Universidad de Murcia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in the microbiota in feces | The investigators will analyze the changes in the diversity and abundance of microbiota to evaluate the prebiotic effect of polyphenols and to understand the bioavailability | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Other | Analysis of metabolites and catabolites of (poly)phenols in different biological samples | The investigators will analyze in urine and feces the metabolites and catabolites of (poly)phenols to evaluate their bioavailability | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Primary | Changes in serum levels of glucose and insulin. | The investigators will measure the changes in levels of glucose and insulin. samples | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Primary | Changes in plasmatic lipid profile. | the investigators will measure the changes in levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and total triglycerides. | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Primary | Changes in blood pressure. | Both, systolic blood pressure (SBP), and diastolic blood pressure (DBP) will be measure. | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Primary | Changes in biomarkers of inflammation in plasma. | The investigators will measure the CRP, the TNF-a, the adiponectin, the soluble vascular cell adhesion molecule 1 (sVCAM-1) and the soluble intercellular adhesion molecule 1 (sICAM-1). | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Primary | Changes in biomarkers of oxidative stress in urine. | The investigators will measure the level of isoprostanes and malonaldehyde. (MDA) | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Secondary | Changes in body mass index. | The investigators will measure the body mass index (Kg/m^2). | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Secondary | Changes in body composition. | The investigators will measure the percentage of the body fat mass, body lean mass, total body water and body bone mass using a Tanita DC-430-MA analyzer. | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Secondary | Changes hip-to-waist ratio. | The investigators will measure the hip-to-waist ratio. | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) | |
Secondary | Dietary habits (total energy intake and macronutrient distribution). | The diet will be registered during interventions periods. Volunteers registered the intake of food during 24 h (2 days/week) to determine the adherence to the Mediterranean diet and quantify the intake of energy and macronutrients distribution. | At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention) |
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