Impact of the Consumption of (Poly)Phenolic Rich Products on Cardiometabolic Risk Markers in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Changes in serum levels of glucose and insulin.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Total cholesterol lower than 240 mg/dL
排除标准
- •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
研究组 & 干预措施
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.
干预措施: (poly)phenols rich foods (Combination Product)
结局指标
主要结局
Changes in serum levels of glucose and insulin.
时间窗: 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)
The investigators will measure the changes in levels of glucose and insulin. samples
Changes in biomarkers of oxidative stress in urine.
时间窗: 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)
The investigators will measure the level of isoprostanes and malonaldehyde. (MDA)
Changes in blood pressure.
时间窗: 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)
Both, systolic blood pressure (SBP), and diastolic blood pressure (DBP) will be measure.
Changes in biomarkers of inflammation in plasma.
时间窗: 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)
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).
Changes in plasmatic lipid profile.
时间窗: 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)
the investigators will measure the changes in levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and total triglycerides.
次要结局
- Changes 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).(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 mass index.(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.(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))
研究者
Mª Jesús Periago
PhD, Full Professor of Nutrition and Food Science
Universidad de Murcia
