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Introduction: Sexology is a field of study to which too little attention has been paid over the years. It is still regarded as relatively new and is constantly expanding. Undoubtedly, sexual health affects a person's overall heath, influencing not only the development of a person's personality, but also their social communication skills and ability to love. Sexuality, in turn, is also related to reproductive health and mental well-being. The objective of the study was to evaluate female sexual functioning taking into account sociodemographic factors. Material and methods: 333 women aged 20-65 years were enrolled in the study. The anonymous online Female Sexual Function Index questionnaire was distributed via social media. It was enriched with sociodemographic questions and selected questions related to gynaecology (age of first menstruation, treatment). In the descriptive analysis, the non-parametric Mann-Whitney U test was used to assess differences in a single trait between 2 groups of women. However, the correlation between the 2 variables was calculated using Spearman's R correlation coefficient. Results: The highest scores were noted in the domain of sexual-related pain (6) - average of 4.94 pts, and sexual satisfaction (5) - average of 4.77 pts. The lowest scores were observed in the domain of arousal (2) - average of 4.34 pts, and desire (1) - average of 3.5 pts. A slightly higher rate of women with possible sexual dysfunction was reported in rural areas - 31 women (33.3%), and in urban areas - 75 women (31.3%). The highest rates of women with possible sexual dysfunction (score ≤ 26 pts) were reported among women with obesity - 21 (44.7%) and overweight - 31 (31.0%), while the lowest rate was recorded in women with normal body mass index (BMI) - 51 (29.0%). Conclusions: There is a statistical relationship between demographics such as age and female sexuality. Age was in low correlation with the results of domains such as desire, arousal, lubrication, and overall sexual functioning. There was a statistical relationship between BMI and the arousal domain, which remained in low correlation with each other. There was no statistical relationship between demographics such as place of residence and women's sexuality. Body mass index did not statistically affect domains such as desire, lubrication, orgasm, sexual satisfaction, sexual pain complaints, and general sexual functioning.
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Background: Dysmenorrhea, characterised by painful menstrual cramps, is a pressing issue among adolescent girls globally. It significantly impacts their quality of life and has been associated with increased mental health issues and engagement in risky behaviours like smoking. In Poland, there is limited research on menstrual health, emphasising the need for a study to understand dysmenorrhea experiences and their impact on young menstruating individuals. Methods: This research project investigated the effects of dysmenorrhea on quality of life and school attendance, as well as its associations with non-communicable diseases, including mental health among adolescent girls in Poland. Additionally, the study examined risk factors for non-communicable disease development, including high-risk health behaviours and exposure to violence. The study utilised a cross-sectional design, administering self-reported questionnaires in high schools and vocational schools in six voivodeships (regions) in Poland. The analysis was performed using the R language in the Rstudio environment. p-value < 0.05 was considered significant. Results: A significant percentage of respondents experienced heavy menstruation, irregularity, and pain. Adolescents with dysmenorrhea reported higher rates of school absenteeism, mental health issues (such as anxiety and panic attacks), and a higher likelihood of engagement in risk behaviours like smoking and illicit drug use. The study also identified associations between dysmenorrhea and experiences of violence, including sexual abuse and intimate partner violence, as well as links to self-harm and suicidal ideation. Conclusions: These findings contribute to understanding dysmenorrhea among Polish adolescent girls, emphasising the need for tailored interventions and support services. The study underscores the necessity of addressing menstrual health comprehensively, considering its impact on various aspects of young women's lives and promoting their overall well-being.
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As can be seen from research, 44% of oncological problems disclose problems in relationships with a partner. About 80% of oncological patients report deterioration of the quality of their sexual life. Although the situation improves, a significant majority of ill persons do not obtain assistance in the scope of sexuality during oncological treatment. Intimacy is an important sphere of life and can support the process of recovery. Intimacy plays special role in the difficult period of the fight against disease. Independently of the applied method of oncological treatment, side effects of therapy can influence one's sexual life. This means that an increasing number of persons who are healed from cancerous disease are exposed to the long-term undesirable influence of treatment. The process of oncological treatment has an essential impact on the intimate life of those who suffer from oncological diseases. To a great extent, this process and the disease itself contribute to a decrease of the quality of life due to the appearance of symptoms caused by earlier menopause, they negatively influence the feeling desire and sexual performance. Unfortunately, despite the development of oncosexology, sexual problems of oncologically ill persons are not noticed, and sometimes they are played down or overlooked due to everyday problems.
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THE PURPOSE OF THE ARTICLE: The article aims to indicate the interdisciplinary and complex nature of the problem of adolescent pregnancy. MATERIALS AND METHODS: An analysis of materials contained in the literature on adolescent pregnancy was used. RESULTS: Adolescent pregnancy is both a serious health and social challenge. Lack of proper sex education, regressive age of sexual initiation, emotional immaturity and limited access to contraception are the main reasons for teenage pregnancy. It can also be the result of sexual abuse, which is a punishable offense. Pregnancy in minors is associated with a higher risk of complications for both the mother and the fetus, such as hypertension, preterm birth, low birth weight, fetal growth restriction, and preeclampsia. Pregnancy is a significant psychological burden and a major trauma for girls. Low socioeconomic status and lack of support from the family or partner exacerbate this problem, increasing the risk of depression and substance abuse. As a multidisciplinary problem, it requires action on multiple fronts to prevent it and to reduce the number of adolescent pregnancies. Increasing access to contraception, medical care, and sexual education is crucial in combating this issue. Adolescent pregnant women are a group of women who require special antenatal care. When planning educational activities for these patients, one should remember about the specific needs of said girls related to key nutrients such as iodine, iron, folic acid, and calcium. A poor diet may result from difficult living conditions and conflicts with family and partners. Moreover, this pregnancy is often unplanned. CONCLUSIONS: A good solution for pregnant adolescents would be the possibility of specialized assistance not only in gynecology and obstetrics, sexology, but also pedagogical, psychological, sociological and dietary.
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Embarazo en Adolescencia , Humanos , Femenino , Embarazo , Embarazo en Adolescencia/psicología , Adolescente , Complicaciones del Embarazo/psicología , Complicaciones del Embarazo/epidemiología , Educación SexualRESUMEN
This study was conducted in two groups of girls with PCOS (polycystic ovary syndrome) categorized as slim (group N) and overweight-to-obese (group Ov/Ob). The study's primary outcome was to assess the impact of a 12-week anti-inflammatory diet (AIDiet) intervention, without energy deficit, on daily diet quality improvement, evaluated according to the KIDMED index. The secondary outcome was improving inflammatory, redox, hormonal, and metabolic statuses. In the study, which was completed by 13 girls from the Ov/Ob group and 19 girls from the N group, a significant improvement in the mean KIDMED score was obtained. Moreover, the intervention significantly improves concentration of total antioxidant capacity (TAC), fasting insulin, and the homeostatic model assessment for insulin resistance (HOMA-IR) index, in the Ov/Ob group, while both groups experienced a reduction in the concentration of interleukin (IL)-1 and IL-6, tumour necrosis factor (TNF-α), and androstenedione. The AIDiet intervention effectively improved the quality of the subjects' diets, which was associated with the improvement of hormonal and immuno-metabolic markers. However, these changes in normal-weight patients were observed regardless of body weight reduction. ClinicalTrials.gov Identifier NCT04738409.
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Resistencia a la Insulina , Síndrome del Ovario Poliquístico , Femenino , Humanos , Sobrepeso/terapia , Sobrepeso/complicaciones , Síndrome del Ovario Poliquístico/metabolismo , Proyectos Piloto , Dieta , Insulina , Antiinflamatorios , Índice de Masa CorporalRESUMEN
The aim of this study was to investigate the association between PMS (premenstrual syndrome)-related pain among young women following a particular type of diet during the COVID-19 pandemic. This was compared to the period before the pandemic. Furthermore, we aimed to determine whether the increase in the intensification of pain was correlated to their age, body weight, height and BMI, and whether there are differences in PMS-related pain between women who differ in their diet. A total of 181 young female Caucasian patients who met the criteria for PMS were involved in the study. Patients were divided according to the kind of diet they had followed during the last 12 months before the first medical evaluation. The rise in pain score was evaluated according to the Visual Analog Scale before and during the pandemic. Women following a non-vegetarian ("basic") diet had a significantly higher body weight in comparison to those on a vegetarian diet. Furthermore, a significant difference was noted between the level of intensification of pain before and during the pandemic in women applying a basic diet, a vegetarian and an elimination diet. Before the pandemic, women from all groups felt weaker pain than during the pandemic. No significant difference in the intensification of pain during the pandemic was shown between women with various diets, nor was there a correlation between intensification of pain and the girl's age, BMI, their body weight and also height for any of the diets applied.
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Human Papillomavirus (HPV) is the main cause of cervical cancer and genital warts and constitutes one of the most common sexually transmitted infections. Cervical cancer is the only reproductive cancer that has a primary prevention programme through the introduction of HPV vaccinations. Even though the majority of European countries have nationally funded HPV vaccination programmes, in Poland these are exclusively local and scarcely funded. Moreover, the majority of local programmes are directed to females only. Meanwhile, Poland has one of the highest cervical cancer incidence rates among high income countries. The aim of this study was to measure HPV vaccination levels among final-year students in Poland and to establish the association between vaccination status and gender, region and level of sexual education received. This study is a part of the POLKA 18 Study, which used original self-reported paper-based questionnaires distributed in schools in six Polish regions. The study was conducted between April and December 2019. The obtained data were analysed in STATA 17. In total, 2701 fully completed questionnaires were collected. Over half of the respondents (58.2%) did not know their HPV vaccination status. Only 16.0% of the respondents replied that they have been vaccinated against HPV (18.2% of females and 14.5% of males). There was no direct association between vaccination status and access to 'family life education' classes. The vaccination level significantly differed among the different regions of Poland (p < 0.0001), with the Slaskie and Wielkopolskie regions achieving the highest rates. At least a quarter of adolescents after their sexual debut have not been vaccinated against HPV. Regions with immunization programmes introduced to their provincial capitals had higher vaccination rates. Our findings indicate the need for the introduction of state-funded vaccination programmes at the national level for the vaccination rate to increase, which will have the potential to decrease cervical cancer incidence in the country.
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HIV data for 2020 show a decline in the number and rate of new HIV cases diagnosed in the EU during the last decade. The COVID-19 pandemic has paralyzed the functioning of healthcare facilities in Poland and worldwide, also impacting the detection of HIV infection. Early diagnosis of HIV and implementation of antiretroviral treatment limit HIV transmission. A woman with HIV diagnosed during pregnancy should be under the care of a specialist in infectious diseases experienced in antiretroviral treatment. In this way, she will be properly protected during the delivery, and relevant medications can be implemented for the newborn baby. Taking these aspects into account, the medical team should consist of: A specialist in infectious diseases, an obstetrician, a neonatologist and pediatrician, a midwife, and a dermato-venereologist. Every effort should be made to increase the scope and quality of monitoring of the spread of the epidemic in Poland, with special emphasis on diagnostics based on specific tests among populations particularly exposed to HIV infections cooperating with non-governmental organizations.
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Patients with endometriosis had limited possibilities for contemporary diagnosis and treatment during the SARS-CoV-2 (COVID-19) pandemic. Surgeries that may have eliminated pain or restored fertility were postponed. Endometriosis may affect the vagina, peritoneum, bladder, or other organs outside the pelvis and impact women's sexual health, especially during pandemics. Holistic care of patients is crucial to improving their lives and sexual health. A scoping review was conducted to analyze the relevant literature in light of our experience in gynecology and physiotherapy during the COVID-19 pandemic.
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Oxidative stress has been implicated in many diseases, including reproductive and pregnancy disorders, from subfertility to maternal vascular disease or preterm labour. There is, however, discrepancy within the standardized markers of oxidative stress in obstetrics and gynaecology in clinical studies. This review aims to present the scope of markers used between 2012 and 2022 to describe oxidative stress with regard to reproduction, pregnancy, and pregnancy-related issues. Despite the abundance of evidence, there is no consensus on the set of standardised markers of oxidative stress which poses a challenge to achieve universal consensus in order to appropriately triangulate the results.
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Movement is a physiological phenomenon and a fundamental aspect of the living human body in a global context (e.g., musculoskeletal system function) and local one (e.g., visceral system function). The local activity of the body is expressed in the rhythm of pulsations, peristalsis and vibrations. Visceral therapy supports movement, articulation and tissue rhythm. The use of visceral treatment for pain is complementary and is relevant for pregnant women. Maintaining the mobility and motility of internal organs by means of visceral techniques can regulate anatomical relations and physiological processes within the urogenital diaphragm. The role of physical activity is also important. A scoping review was conducted to analyze the relevant literature on pain in pregnant women, the role of visceral therapy in pregnant women and oxidative stress. Eligible articles presented aspects of the occurrence of pain in locomotive organs in pregnant women, the use of visceral therapy in pain management, and the reduction of oxidative stress. The use of visceral therapy and physical activity in the treatment of pain is complementary and also important for pregnant women, and so may have an effect on reducing oxidative stress in pregnant women.
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Dyspareunia is genital pain during sexual intercourse without constriction of the vulva or vagina. This is one of the most significant issues that lies at the border of gynaecology and sexology. Dyspareunia can be caused by endometriosis. Many women can also experience premenstrual syndrome, which can occur as a separate problem. All three of these can result from an imbalance between the female genital organs and their surrounding tissues with other structures of the skeletal or visceral system, with impaired mobility and motility of organs, intra-organ movement, vascular drainage, a pressure gradient between the urogenital and diaphragmatic cylinders, dysfunctions in the area of the broad ligament of the uterus, and fascial bonding. Apart from standard treatment methods used in gynaecology and sexology, physiotherapy (e.g., visceral therapy) is of great value. Visceral therapy aims at restoring intra-organ movement, reducing tension, focusing on the area of the two cylinders of the trunk, and supporting the functioning of the vascular system in the vicinity of the uterus. All these activities reduce pain and substantially change the functioning of the uterus and ovaries.
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Dispareunia , Endometriosis , Dispareunia/etiología , Endometriosis/complicaciones , Femenino , Humanos , Dolor , VaginaRESUMEN
We investigated whether long-term social restrictions and COVID-19 exposure have different impacts on the mental and sexual health of Polish women compared to the effects experienced at the beginning of the pandemic. An online survey was conducted among Polish women via Facebook groups. The Beck Depression Inventory (BDI) and Female Sexual Function Index (FSFI) scores were compared for the first wave (April-May 2020) and the second wave (November 2020 to February 2021) of the pandemic. We enrolled 1644 participants (mean age 25.11 ± 7.09 years) during the first wave and 720 participants (mean age 23.23 ± 5.34 years) during the second wave of COVID-19 pandemic. Significant differences were observed in libido levels and frequency of sexual activity before and during the first and second wave of the COVID-19 pandemic (both p < 0.001). The percentage of participants under psychiatric or psychological care increased from 6.5% to 14.44% and those who were anxious about the health conditions of loved ones increased from 57.5% to 65.14%. BDI scores increased significantly from 11 (IQR 5-18) to 12 (IQR 7-20). The change in the FSFI score was not significant (27.01 ± 7.61 vs. 26.38 ± 7.76). The COVID-19 pandemic affected various aspects of human life, including sexual life. The data obtained during the first and the second wave of the COVID-19 pandemic in Poland showed that female sexual dysfunction did not differ, but depressive symptoms and fear intensified.
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COVID-19 , Pandemias , Adolescente , Adulto , Ansiedad , Femenino , Humanos , Polonia/epidemiología , SARS-CoV-2 , Adulto JovenRESUMEN
Proper diet and physical activity are a form of prevention of female genital prolapse disorders. The causal substrate of pelvic floor dysfunction is multifactorial. Fifty percent of women over the age of 50 have pelvic organ prolapse, often accompanied by urinary incontinence. It is a complicated social and medical (urogynecological and sexological) problem. The authors conducted a literature review on the role of visceral therapy, Kegel and core stability exercises and diet in pelvic support disorders and urinary incontinence. The eligible articles provided insights into sexological factors, as well as the role of osteopathy and physiotherapy. These results provide new insights into the relevance of clinical practice. In addition to standard treatment methods used in gynaecology, sexology, physiotherapy and osteopathy (e.g., visceral therapy), Kegel muscle and core stability exercises are becoming increasingly important. The aim of visceral therapy is to restore the mobility of the organs while reducing increased tension and improving blood and lymph circulation. This has the effect of reducing pain sensations, thereby influencing the function of the uterus and ovaries.
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Estabilidad Central , Incontinencia Urinaria , Femenino , Humanos , Incontinencia Urinaria/terapia , Modalidades de Fisioterapia , Dieta , MúsculosRESUMEN
Inflammation within the genital organs in women is an important problem in gynaecology and venereology. Understanding the factors contributing to the inflammatory process and the role of defence mechanisms against their occurrence is important in terms of prevention and treatment. It is especially visible in paediatric gynaecology, where inflammatory diseases of the vulva, dermatoses, injuries and the effects of possible sexual harassment may overlap.
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Getting to know the history of syphilis should begin with an attempt to establish the original source of its spread throughout the world. The dispute about the origin of syphilis, a sexually transmitted infection caused by Treponema pallidum (subspecies pallidum), had not been resolved even as late as in the twenty-first century, and to this day the supporters and opponents of the thesis that syphilis was brought to Europe by Christopher Columbus' sailors have been fighting without solid and sustainable foundations. The French named syphilis "the Neapolitan disease", while the Italians called it "the French disease".
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INTRODUCTION: The Female Sexual Function Index (FSFI) is recognized as an excellent tool for assessing female sexuality and screening female sexual dysfunction, but it also has important venereological implications as sexually transmitted diseases result from human behaviour in the sexual sphere. It is influenced by socio-economic, psychological and cultural factors. AIM: To present the results of an attempt to implement FSFI in gynaecological practice. MATERIAL AND METHODS: The study comprised 91 women aged 20-35 (mean: 24.3 ±4.0) undergoing prophylactic gynaecological examinations. All of them voluntarily agreed to fill in the FSFI questionnaire, and provide data on weight, height, hormone treatments, the age of menarche and sexual initiation and information essential in health promotion and prevention, including the prevention of sexually transmitted diseases. RESULTS: The average age of the first sexual intercourse was 18.2 ±2.4. The total FSFI score ranged from 3.8 to 35.1 points (mean: 27.4 ±6.5). As many as 34.1% of the women presented with FSFI < 27.50, suggesting an increased risk of sexual dysfunction. Patients' age as well as the age of menarche were both negatively correlated with desire. The mean FSFI scores for almost all of the domains and the FSFI total score were higher for women taking oral contraceptives, although statistically significant differences were detected only for the orgasm domain. CONCLUSIONS: A high percentage of sexually active Polish women presented with FSFI below the threshold, suggesting some grade of sexual dysfunction. Gynaecological and STI medical history should be extended to include issues related to female sexual function.
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The role of inappropriate lifestyle in the etiology of polycystic ovary syndrome (PCOS) and its metabolic and reproductive complications has attracted much attention in recent years; however, most studies involve adult patients. Thus, the study aimed to compare dietary patterns, physical activity, metabolic, anthropometric and inflammatory markers of 14-18-year-old girls with and without PCOS (n = 61 and n = 35, respectively) as well as to assess correlations between concentrations of metabolic and inflammatory markers and macronutrient intake and to identify the independent predictors of PCOS, related to diet and physical activity (PA). Compared to the control group, PCOS girls consumed significantly more total fat (p = 0.0005), including both saturated (SFA) (p = 0.03), monounsaturated (MUFA) (p = 0.0003) and polyunsaturated fatty acids (PUFA) (p = 0.01). A significantly higher percentage of PCOS patients consumed high and medium glycemic index (GI) foods (p = 0.03) and represented a low level of PA, both during school and in leisure time (41.67 vs. 6.06%; p = 0.0001 and 32.79 vs. 5.71%; p = 0.003, respectively). The PCOS group had also significantly higher waist circumference (WC), C-reactive protein (CRP) (p = 0.01), LDL cholesterol (p = 0.01), fasting insulin (p = 0.002) and HOMA-IR (p = 0.006) levels. There was an inverse correlation between fiber intake and fasting insulin, (p = 0.0002, r = -0.37), HOMA-IR (p = 0.0004, r = -0.35), WC (p = 0.029; r = -0.222) and a positive relationship between high and medium GI diet and insulin concentration (p = 0.003; r = 0.3). An increase of 10 g/day in total fat intake per day increases the probability of PCOS by 1.4 times. If the SFA or MUFA intakes increase by 10 g, the probability of PCOS increase 1.7-fold and 2.5-fold, respectively. The consumption of foods with a medium GI raises the probability of PCOS by more than 3 times, after adjusting for age. The odds ratio decreased for the moderate and high PA at school/work and in leisure time. Further research in girls with PCOS is needed to test whether low GI and dietary fatty acid reduction combined with increased PA is effective in the nonpharmacological treatment and prevention of PCOS complications. ClinicalTrial.gov Identifier: NCT04738409.
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BACKGROUND: Research studies indicate that polycystic ovary syndrome (PCOS) may increase susceptibility to periodontal disease. The mechanisms that link both conditions are not entirely understood. Thus, the study aimed to investigate the impact of hormonal and metabolic disturbances on the gingival health and salivary levels of tumor necrosis factor (TNF-α), interleukin 1ß (IL1-ß), and interleukin 6 (IL-6) in adolescent girls with PCOS. METHODS: Thirty-one patients with PCOS and twenty-eight healthy age-mates (as the control group) were enrolled in the study. Individuals with PCOS underwent blood tests for the determination of hormonal and metabolic parameters. Saliva samples were collected to measure salivary testosterone and proinflammatory cytokines in both studied groups. Calibrated dentist assessed oral hygiene and gingival health of all subjects. RESULTS: Salivary testosterone was significantly higher in the study group (p = 0.0007). The groups did not differ significantly concerning periodontal parameters. Patients with PCOS revealed higher levels of salivary cytokines (p < 0.0001). Gingival index (GI) and the percentage of sites bleeding upon probing (BOP%) were positively correlated with the plaque index (PI) in both groups (rs ≥ 0.60, p < 0.001), and negatively correlated with salivary testosterone level in the PCOS group (rs = - 0.44, p = 0.0138 and rs = - 0.37, p = 0.0424, respectively). BOP% was also positively correlated with body mass index (BMI) in the control group (rs = 0.40, p = 0.0368) and index of insulin resistance (HOMA-IR) in the study group (rs = 0.48, p = 0.0068). Salivary testosterone was positively correlated with TNF-α in the control group (rs = 0.41, p = 0.0321), while in the study group, total testosterone (TT) was positively correlated with IL-6 (rs = 0.37, p = 0.0400) and free androgen index (FAI) with TNF-α (rs = 0.36, p = 0.0491). CONCLUSIONS: Gingival health of the examined population was associated primarily with oral hygiene and, to a lesser extent, with the hormonal and metabolic profile. Despite similar periodontal parameters in the both studied groups, patients with PCOS revealed significantly higher levels of proinflammatory cytokines in saliva, which might be the manifestation of the systemic low-grade inflammation associated with PCOS.
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Resistencia a la Insulina , Síndrome del Ovario Poliquístico , Adolescente , Índice de Masa Corporal , Citocinas , Femenino , Humanos , Síndrome del Ovario Poliquístico/complicaciones , SalivaRESUMEN
The impact of diet on inflammation and oxidative stress (OS) in girls with polycystic ovary syndrome (PCOS) is unknown. Therefore, our study aimed to investigate, in PCOS girls, whether certain macronutrient intakes can be associated with these disturbances. For this purpose, 59 PCOS participants (aged 14-18 years) were recruited to this study and divided into two subgroups: overweight/obese-Ov/Ob group (n = 22) and normal weight-N group (n = 37). Nutrition was assessed using a 3-day food record. The studied markers were total antioxidant capacity (TAC), malondialdehyde (MDA), C-reactive protein (CRP), tumor necrosis factor α (TNF-α), and interleukins 1 and 6 (IL-1 and IL-6). We found plant protein intake inversely correlated with IL-6 (p = 0.007; r = -0.557), TNF-α (p = 0.006; r = -0.564), MDA (p = 0.01; r = -0.539) in the Ov/Ob group and with TAC (p = 0.021; r = -0.38) in the N group. Inverse correlations in the Ov/Ob group were observed between protein intake and IL-6 (p = 0.031; r = -0.461), TNF- α (p = 0.043; r = -0.435); carbohydrates and IL-6 (p = 0.037; r = -0.448), MDA (p = 0.045; r = -0.431); fiber and IL-6 (p = 0.025; r = -0.475). A positive relationship between cholesterol intake and CRP concentration (p = 0.038; r = 0.342) was also found in the N group. These findings revealed that inflammation and OS are increased in Ov/Ob girls with decreased plant protein intake and low carbohydrates in the diet. Moreover, inflammation may be increased by cholesterol intake in slim PCOS girls. On the other hand, decreased intake of fiber and total protein intake increased inflammation. ClinicalTrials.gov Identifier: NCT04738409.