Effect of (Poly)Phenolic on Cardiometabolic Risk of Postmenopausal Women
Condition: Post-menopausal Women; Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): (poly)phenols rich foods
Intervention type(s): Combination Product
Intervention description(s): 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.
Intervention MeSH terms: Phenol
Intervention model: Single Group Assignment
Intervention model description: Single group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Menopause; (Poly)phenols; Cardiometabolic risk; Oxidative stress; Lipid and glucose metabolism