Pilates mat exercises and supplementation as strategies to promote health in women 50+

INTERVENTION: This is a phase 1, randomized, placebo‐controlled, prospective, two‐arm parallel clinical trial, conducted in a double‐blind, third‐person blinding design, which aims to evaluate the effects of Mat Pilates practice, with or without a new phytotherapeutic supplement containing annatto (Bixa orellana L.), yerba mate (Ile Xparaguariensis A. St.‐Hil.) and hops (Humulus lupulus L.), on metabolic and inflammatory biomarkers, Quality of Life (QoL), cognitive function, menopausal symptoms, and muscle strength in menopausal women aged 50 years or older. The study approach is both quantitative and qualitative, in which participants recruited through social networks and the Elderly Care and Reference Center of the University of Passo Fundo (CREATI‐UPF) will undergo initial screening and subsequently be allocated to two groups: Mat Pilates combined with the new phytotherapeutic supplement developed in gummies or Mat Pilates combined with a placebo, also in gummies. Twenty participants will be selected and randomly assigned, through an impartial draw, to two different groups (A and B) of 10 participants each to participate in the interventions. The interventions will last 12 weeks (24 sessions), with Mat Pilates sessions supervised by a physical education professional, held twice a week for 45 minutes each. Assessments will occur at baseline (before the interventions) and after 3 months, including analysis of biomarkers (skin autofluorescence as an indirect marker of advanced glycation end products, homocysteine, lipid profile, inflammatory markers, hormonal tests, and oxidative stress), food diary, Quality of Life (WHOQOL‐Bref), cognitive function (Montreal Cognitive Assessment – ??MoCA), muscle strength (handgrip strength test), habitual level of physical activity (International P CONDITION: G07.345.124 Menopause; Women’s Health; Quality of Life ; Aging PRIMARY OUTCOME: To verify the impact of Mat Pilates practice, associated or not with the use of a compound containing annatto, yerba mate, and hops, on biomarkers, quality of life (QoL), cognitive function, menopausal symptoms, and strength in menopausal women aged = 50 years, over a period of 3 months INCLUSION CRITERIA: To participate voluntarily in the study, participants must: understand the study procedures and agree to participate voluntarily and sign the Informed Consent Form; be 50 years of age or older; be menopausal (12 months or more of amenorrhea); be willing to use the new supplementation with annatto (Bixa orellana L), yerba mate (Ile Xparaguariensis A. ST.‐Hil.) and hops (Humulus lupulus L.) throughout the study; not be using hormone replacement therapy; and have a skin phototype between I and IV on the Fitzpatrick scale (MSD Manuals Professional Edition, [n.d.]), since the equipment used for cutaneous autofluorescence analysis has adequate sensitivity only for these phototypes, ensuring the reliability of the measurements SECONDARY OUTCOME: Assess cognitive functions using the Montreal Cognitive Assessment (MoCA) scale before and after the interventions Assess Handgrip Strength (HGS) before and after the interventions using a Crown® brand manual dynamometer – 100 kgf. Participants will be seated in a chair with their forearms resting on the chair arms and their wrists on the ends. The thumb will be positioned pointing upwards. After a brief demonstration, each participant will perform three attempts on each side, alternating between the right and left hand. A 1‐minute interval will be taken between each attempt. Finally, the average of the 3 measurements from each side will be calculated to obtain the result Assess quality of life using the WHOQOL‐bref questionnaire – short version, before and after the interventions Conduct a mixed‐methods qualitative interview with the participants, containing 7 open‐ended questions developed by the researcher, aiming to understand the perceptions, experiences, and meanings attributed by the participants to the interventions performed. This interview will be conducted after the interventions Estimate the habitual level of physical activity of each participant using the International Physical Activity Questionnaire (IPAQ) – Short Form. This questionnaire will be applied before and after the interventions Evaluate advanced glycation end products (AGEs) using skin autofluorescence (SAF) and homocysteine ??levels, which will be assessed by a contracted laboratory using peripheral blood samples, both before and after the interventions Evaluate blood count and platelet count before and after the procedures; this will be performed by a contracted laboratory through peripheral blood collection Evaluate fasting blood glucose levels before and after the interventions; this will be performed by a contracted laboratory through peripheral blood collection Evaluate the lipid profile (total cholesterol, triglycerides, HDL, LDL, and VLDL) before and after the interventions; this will be performed by a contracted laboratory through peripheral blood collection Evaluating Oxidative Stress (OS) before and after the interventions will be carried out in the pharmacy course laboratory at the University of Passo Fundo. The assays performed to evaluate oxidative stress markers are: non‐protein thiols (glutathione), nitric oxide, and lipid peroxidation in plasma. For the determination of non‐protein thiols, and indirectly of reduced glutathione (the enzyme responsible for the reduction of GSSG to GSH in tissues), the assay described by Ellman (1959) will be used in plasma by measuring a product that reacts with 10 mM DTNB, and reading at 412 nm. For the determination of nitric oxide, the Griess reaction will be performed using a sodium nitrite standard curve as described by Bracht and Ishii‐Iwamato (2003). In the evaluation of lipid peroxidation, the amount of malondialdehyde derived from lipid peroxidation will be measured (thiobarbituric acid reactive substances – TBARS – are measured) by heating the biological material to be tested at 100 °C for 15 minutes in the presence of thiobarbituric acid, under acidic conditions, measuring the formation of a color product spectrophotometrically at 535 nm (Ohkawa; Ohishi; Yagi, 1979). All these results will be normalized with the protein content determined by the Lowry method Evaluating se Xhormones (estrogen, progesterone, etc.) before and after the procedures will be done by a contracted laboratory through peripheral blood collection Evaluating very low levels of chronic inflammation in the blood (high‐sensitivity C‐reactive protein ‐ CRP) before and after the interventions will be performed by a contracted laboratory through peripheral blood collection To identify the variation in symptoms that apply to menopause for each participant using the Menopause Rating Scale (MRS) questionnaire. This questionnaire will be administered before and after the interventions