Effect of (Poly)Phenolic on Cardiometabolic Risk of Postmenopausal Women (CARDIOGENE)

Impact of the Consumption of (Poly)Phenolic Rich Products on Cardiometabolic Risk Markers in Postmenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Post-menopausal Women
• Intervention / Treatment: Combination product: (poly)phenols rich foods

Detailed Description

Menopause is a stage characterized by the sudden decrease in estrogens linked to the absence of amenorrhea for at least 12 months. Estrogens are involved in certain metabolic pathways such as lipids metabolism and the distribution of body fat in the body. As a result of the fall of estrogen production, postmenopausal women experience a number of alterations of the energy homeostasis that are accompanied by an increase in body weight and a tendency to obesity and visceral fat deposition, as well as variations in the levels of total cholesterol (T-C), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TGs), increasing the risk for cardiometabolic diseases. In addition, menopause contributes to disorders of the glucose metabolism increasing insulin resistance (IR) that can predispose to the development of type 2 diabetes mellitus (T2DM).

(Poly)phenols are recognized as bioactive compounds with general antioxidant and anti-inflammatory activity and as potent vasodilators and stimulators of the immune response with the capacity to modulate a range of cardiovascular and metabolic risk factors. An increasing number of intervention studies have built up the evidence of the cardiovascular and metabolic benefits of the intake of these compounds in humans, however, the results remain limited and contradictory, leading to the current controversy regarding the consistency and magnitude of the protective effects that these compounds exert in humans. The lack of consistent and significant results may be partially due to the heterogeneity of the studies and the interindividual variability of the participants.

The investigators have designed this intervention to clearly described the effects of the (poly)phenolic compounds in postmenopausal women with a well-characterized cardiometabolic status. The observed beneficial effects will be correlated with the absorption and metabolism of these compounds.

The protocol will be a single arm intervention study with 22 postmenopausal women as a participants. Prior to start the intervention (initial time of the study) the volunteers will follow their habitual diet during 30 days as a control period. Immediately, they will start with the intervention period (baseline) following their habitual diet supplemented with (poly)phenol rich products, eating daily 100 ml of a commercial juice of berries and pomegranate, 20 g dark chocolate and 1 green tea, during 60 days (after intervention).

At the beginning of the study (initial time), at the beginning of the intervention (baseline) and at the end of the intervention (after the intervention) with rich (poly)phenols foods, biological samples (blood, urine and feces) and anthropometric measurements will be taken. In addition, the participants will record the food intake weekly with a 24 h dietary-recall form.

The investigators will evaluate followed parameters: 1) glucose metabolism indicators, i.e. glucose, insulin and Homeostatic Model Assessment of IR (HOMA-IR), 2) lipid profile (T-C, LDL-C, HDL-C and TGs), 3) blood pressure, both, systolic blood pressure (SBP), and diastolic blood pressure (DBP), 4) biomarkers of inflammation, CRP, TNF-α, adiponectin, soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), 5) biomarkers of oxidative stress: oxidized isoprostanes and malonaldehyde (MDA), 6) body mass index, body fat and waist-to-hip ratio, 7) dietary habits (total energy intake and macronutrient distribution), 8) metabolites and catabolites of (poly)phenols, and 9) changes in the microbiota.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30100
    • Edificio Pleyades-Vitalys 5ª y 6ª planta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intake of (poly)phenol rich foods; Daily consumption of 100 ml of a commercial juice of berries and pomegranate, 20 g dark chocolate and 1 green tea, to test if the supplementation of the diet with (poly)phenol rich foods, during 2 months, reduce the cardiometabolic risk in post-post-menopausal women.

Combination product: (poly)phenols rich foods; Prior to start the intervention (initial time of the study) the volunteers will follow their habitual diet during 30 days as a control period, and then they will start with the intervention period (baseline) following their habitual diet supplemented with (poly)phenol rich products during 60 days (after intervention). At the beginning of the study (initial time), at the beginning of the intervention (baseline) and at the end of the intervention (after the intervention) with rich (poly)phenols foods, biological samples (blood, urine and feces) and anthropometric measurements will be taken. In addition, the participants will record the food intake weekly with a 24 h dietary-recall form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Changes in biomarkers of inflammation in plasma.	The investigators will measure the CRP, the TNF-α, 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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Universidad de Murcia
• Investigators: Study Director: Maria J Periago Castón, Full Prof., Universidad de Murcia; Principal Investigator: Rocio González Barrio, Assis. Prof., Universidad de Murcia

Publications and helpful links

Helpful Links

• Previously to this intervention study we have done a systematic review about the consumption of (poly)phenol-rich products and the effect on cardiometabolic risk in post-menopausal women.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Oxidative stress; Menopause; Cardiometabolic risk; Lipid and glucose metabolism; (Poly)phenols
• Additional Relevant MeSH Terms: Body Weight; Overweight; Anti-Infective Agents, Local; Anti-Infective Agents; Pharmaceutical Solutions; Disinfectants; Sclerosing Solutions; Phenol
• Other Study ID Numbers: (Poly)phenol and menopause; 20904/PI/2018 (Other Grant/Funding Number: Fundación Séneca (Research Agency of Murcia, Spain))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No