The Effects of Nutritional Characteristics of Obese Men and Women on Their Sexual Functions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 主要终点
- Sexual function in non-obese women [ Time Frame: through study completion, an average of 6 months]
研究概览
简要总结
Sexuality is integral to personality, influencing feelings, thoughts, actions, and physical and mental health. Female sexual dysfunction is a fairly common condition that covers four main areas: hypoactive sexual desire disorder, arousal disorder, orgasmic disorder, and sexual pain disorder. Although incidence and prevalence rates vary, it has been reported that women range between 30% and 50%.
Male sexual dysfunction is not a single disease. Male sexual arousal refers to the entire process of sexual activity for men, including penile erection, penile penetration, ejaculation, and any obstruction in a single connection. It is a significant psychological distress for affected men, their sexual partners, and their health-related quality of life. Sexual dysfunctions are common among men of all ages and ethnic and cultural backgrounds. It is reported in the literature that 52% of men between the ages of 40-70 experience various degrees of sexual dysfunction.
Cardiovascular disease, smoking, obesity, sedentary lifestyle, diabetes, hypertension, hyperlipidemia, and metabolic syndrome are risk factors for sexual dysfunction. Although the positive effects of adopting healthy lifestyle changes and dietary habits in reducing the risks of these diseases have been proven, few studies have evaluated the impact of these treatment approaches on sexual dysfunction.
Studies evaluating the relationship between diet and erectile dysfunction have focused more on men with diabetes. Some small studies have also shown that lifestyle modification and weight loss interventions improve erectile dysfunction in men with significant cardiovascular risks. The same is valid for female sexual dysfunction. The Western diet and its components are indirectly associated with sexual morbidity. The Western diet has processed foods, refined carbohydrates, and high sodium and monounsaturated fat content, which have been widely linked to the development of MetS, obesity, and diabetes. These comorbidities are also risk factors for female sexual dysfunction as well.
This study aims to evaluate the relationship between the eating habits of obese and non-obese men and women and their sexual functions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female patients with menstrual bleeding
- •Sexually active male and female patients
- •18 years and older age
排除标准
- •<18 years of age
- •Female patients with menopause
- •Female patients that have undergone hormone therapy in the last 12 months
- •Sexually inactive male and female patients
- •Patients with diabetes
- •Patients with a history of psychiatric illness
- •Patients with cognitive impairment
- •Patients with hormone-dependent tumors
- •Patients taking a drug known to reduce sexual desire
结局指标
主要结局
Sexual function in non-obese women [ Time Frame: through study completion, an average of 6 months]
时间窗: Based on The Female Sexual Function Index (FSFI) questionnaire
A domain score of zero indicates that the subject reported having no sexual activity during the past month Desire: Score Range 1-5; Min-Max score 1.2-6.0 Arousal: Score Range 0-5; Min-Max score 0-6.0 Lubrication: Score Range 0-5; Min-Max score 0-6.0 Orgasm: Score Range 0 (or 1)-5; Min-Max score 0-6.0 Satisfaction: Score Range 0-5; Min-Max score 0.8-6.0 Pain: Score Range 0-5; Min-Max score 0-6.0
Sexual function in non-obese men [ Time Frame: through study completion, an average of 6 months]
时间窗: Based on International Index of Erectile Function (IIEF) questionnaire
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Evaluation of which nutrients the participants consume weekly [ Time Frame: through study completion, an average of 6 months]
时间窗: Based on Alternative Healthy Eating Index
The AHEI grades the diet, assigning a score ranging from 0 (nonadherence) to 110 (perfect adherence), based on how often eat certain healthy and unhealthy foods. For example, someone who reports eating no daily vegetables would score a zero, while someone who ate five or more servings a day would earn a 10. For an unhealthy option, such as sugar-sweetened drinks or fruit juice, scoring is reversed: a person who eats one or more servings would score a zero, and zero servings would earn a 10.
Sexual function in obese women [ Time Frame: through study completion, an average of 6 months]
时间窗: Based on The Female Sexual Function Index (FSFI) questionnaire
A domain score of zero indicates that the subject reported having no sexual activity during the past month Desire: Score Range 1-5; Min-Max score 1.2-6.0 Arousal: Score Range 0-5; Min-Max score 0-6.0 Lubrication: Score Range 0-5; Min-Max score 0-6.0 Orgasm: Score Range 0 (or 1)-5; Min-Max score 0-6.0 Satisfaction: Score Range 0-5; Min-Max score 0.8-6.0 Pain: Score Range 0-5; Min-Max score 0-6.0
Sexual function in obese men [ Time Frame: through study completion, an average of 6 months]
时间窗: Based on International Index of Erectile Function (IIEF) questionnaire
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
次要结局
未报告次要终点
研究者
Fulya Calikoglu
MD, PhD; Academician; Principle Investigator
Istanbul University